APA Format
2 reference minimal
Complete 2-3 page article critique and john hopkins tool
Must use article provided and 1 other outside reference
Part 1: Write a two-page critique on the article Telecoaching plus a portion control plate for weight care management: a randomized trial
Part 2: Complete the
Johns Hopkins Quantitative Research Appraisal Tool (Links to an external site.)
.
Content of critique should include at a minimum:
1. Participant sampling,
2. Questionnaires/tools,
3. Ethics,
4. Analysis of findings,
5. Limitations,
6.
Discussion section,
7. Summary: Application (translation) to practice specialty, and future implications.
Preparing the Assignment:
1. APA Format According to 6th edition.
2. Word Doc per assignment requirements
3. Word Doc Format:
Cover page, no abstract, introduction (no heading per APA), body of the paper/review, reference list, appendix with Johns Hopkins appraisal doc. For review sections refer to your readings and the Johns Hopkins Research Appraisal Tool.
· Article title, author, journal, publication date
· Evidence level and quality
· Analysis of the study methodology (specific to study type, e.g., qualitative versus quantitative versus non-research)
Reference List should include the chosen article and other resources used to construct the review, such as course textbook, Johns Hopkins Evidence Based Practice: Model and Guidelines (2018), and How to Read a Paper by Greenhalgh (2014).
Rubric
NR505NP WK4,5,6 Article Critique_SEPT19
NR505NP WK4,5,6 Article Critique_SEPT19
Criteria
Ratings
Pts
This criterion is linked to a Learning OutcomeIntroduction
Required content for this section includes:
• Introduction to chosen article
• Succinct overview of assignment focus.
10.0 pts
Excellent
Content includes well-written, succinct, information that includes: Article topic/focus, authors and specific aim of assignment.
9.0 pts
V. Good
Content is well-written but omits or is thin in one area.
8.0 pts
Satisfactory
Section content is basic in its explanation of the article (overview) and the purpose of the assignment but lacks specific detail and depth.
5.0 pts
Needs Improvement
All content is included but difficult to piece together in its explanation of the article (overview) and the purpose of the assignment OR a piece of the content is missing, for example, overview of assignment focus, yet what is written is well stated.
0.0 pts
Unsatisfactory
Missing OR Section content is vague in its introduction of the article (overview) and the purpose of the assignment is missing OR article overview is missing, and purpose of the assignment is vague.)
10.0 pts
This criterion is linked to a Learning OutcomeCritique of Article
Required content for this section includes:
• Methodological review specific to type (non-research versus research): (use text and resources)
• Ethical review (not always present with guidelines or systematic reviews)
• Analysis of findings
• Limitations
• Discussion
• Application to practice (translation)
• Future implications
50.0 pts
Excellent
All content is included in the critique with comprehensive definitions, examples and with in-text citations that support the article evaluation with depth.
46.0 pts
V. Good
All content is included in the critique. One or two sections may be included without depth: For example, Definitions, examples and with in-text citations that support the article evaluation with depth. Or: All content has explanatory depth of analysis including definitions, examples and in-text citations supporting the analysis, however, a content area may be missing (such as ethical review or limitations)
42.0 pts
Satisfactory
Two or three content areas are missing, or all content areas are included but there is inconsistent depth/ integration of definitions, examples and in-text citations that support the article evaluation with depth
25.0 pts
Needs Improvement
Four or more content areas are missing, or all content areas are included but there is little to no depth/ integration of definitions, examples and in-text citations that support the article evaluation with depth.
0.0 pts
Unsatisfactory
Critique is vague, without structure, without discernible integration of definitions, examples, and in-text citations that support the writing.
50.0 pts
This criterion is linked to a Learning OutcomeJohns Hopkins Appraisal Tool
50.0 pts
Excellent
All sections of the Appraisal Tool are completed for the correct article review (for example, the non-research tool is used for guidelines, the qualitative tool is used for qualitative review).
46.0 pts
V. Good
Tool is included, is the correct tool, and is missing: A. Non-Evidence Tool: 1 of the 6 sections B. Evidence Tool: 1 section missing
42.0 pts
Satisfactory
Tool is included, is the correct tool, and is missing: A. Non-Evidence Tool 2 or 3 of the 6 sections B. Evidence Tool: 2 sections missing
25.0 pts
Needs Improvement
Tool is included and is missing: A. Non-Evidence Tool 4 or more of the 6 sections B. Evidence Tool – 3 more sections missing.
0.0 pts
Unsatisfactory
Tool is missing or the wrong tool is used.
50.0 pts
This criterion is linked to a Learning OutcomeOrganization & Format
Requirements:
• Cover (title) page
• No abstract
• Introduction
• Body of paper and reference page must follow APA guidelines as found in the 6th edition of the manual. This includes the use of headings for each section of the paper except for the introduction where no heading is used.
15.0 pts
Excellent
All aspects of paper follow APA guidelines (cover, no abstract, introduction, headings (not on introduction), body of paper and reference page
14.0 pts
V. Good
1-3 APA errors
12.0 pts
Satisfactory
4-5 APA errors
8.0 pts
Needs Improvement
6-9 APA errors
0.0 pts
Unsatisfactory
10 or greater APA errors
15.0 pts
This criterion is linked to a Learning OutcomeSyntax, grammar, spelling
Rules of grammar, spelling, word usage, and punctuation are followed and consistent with formal written work as found in the 6th edition of the APA manual.
5.0 pts
Excellent
There are no grammatical, spelling, word usage or punctuation errors.
4.0 pts
V. Good
1-3 grammatical, spelling, word usage or punctuation errors.
3.0 pts
Satisfactory
4-5 grammatical, spelling, word usage or punctuation errors.
2.0 pts
Needs Improvement
6-9 grammatical, spelling, word usage or punctuation errors.
0.0 pts
Unsatisfactory
10 or greater grammatical, spelling, word usage or punctuation errors.
5.0 pts
Total Points: 130.0
Evidence level and quality rating:
Article title:
Number:
Author(s):
Publication date:
Journal:
Setting:
Sample (composition and size):
Does this evidence address my EBP question?
Yes
No- Do not proceed with appraisal of this evidence
· Clinical Practice Guidelines LEVEL IV Systematically developed recommendations from nationally recognized experts based on research evidence or expert consensus panel · Consensus or Position Statement LEVEL IV Systematically developed recommendations, based on research and nationally recognized expert opinion, that guide members of a professional organization in decision-making for an issue of concern |
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· Are the types of evidence included identified? |
· Yes |
· No |
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· Were appropriate stakeholders involved in the development of recommendations? |
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· Are groups to which recommendations apply and do not apply clearly stated? |
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· Have potential biases been eliminated? |
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· Does each recommendation have an identified level of evidence stated? |
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· Are recommendations clear? |
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Findings That Help Answer the EBP Question |
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Complete the corresponding quality rating section. |
Johns Hopkins Nursing Evidence-Based Practice
Appendix F: Non-Research Evidence Appraisal Tool
Johns Hopkins Nursing Evidence-Based Practice
Appendix F
Non-Research Evidence Appraisal
1
· Literature review LEVEL V Summary of selected published literature including scientific and nonscientific such as reports of organizational experience and opinions of experts · Integrative review LEVEL V Summary of research evidence and theoretical literature; analyzes, compares themes, notes gaps in the selected literature |
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· Is subject matter to be reviewed clearly stated? |
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· Is literature relevant and up-to-date (most sources are within the past five years or classic)? |
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· Of the literature reviewed, is there a meaningful analysis of the conclusions across the articles included in the review? |
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· Are gaps in the literature identified? |
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· Are recommendations made for future practice or study? |
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Complete the corresponding quality rating section. |
· Expert opinion LEVEL V Opinion of one or more individuals based on clinical expertise |
· Has the individual published or presented on the topic? |
· Is the author’s opinion based on scientific evidence? |
· Is the author’s opinion clearly stated? |
· Are potential biases acknowledged? |
Organizational Experience · Quality improvement LEVEL V Cyclical method to examine workflows, processes, or systems with a specific organization · Financial evaluation LEVEL V Economic evaluation that applies analytic techniques to identify, measure, and compare the cost and outcomes of two or more alternative programs or interventions · Program evaluation LEVEL V Systematic assessment of the processes and/or outcomes of a program; can involve both quaNtitative and quaLitative methods |
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Sample Size/Composition: |
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· Was the aim of the project clearly stated? |
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· Was the method fully described? |
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· Were process or outcome measures identified? |
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· Were results fully described? |
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· Was interpretation clear and appropriate? |
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· Are components of cost/benefit or cost effectiveness analysis described? |
· N/A |
· Case report LEVEL V In-depth look at a person or group or another social unit |
· Is the purpose of the case report clearly stated? |
· Is the case report clearly presented? |
· Are the findings of the case report supported by relevant theory or research? |
· Are the recommendations clearly stated and linked to the findings? |
Complete the corresponding quality rating. |
Community standard, clinician experience, or consumer preference LEVEL V · Community standard: Current practice for comparable settings in the community · Clinician experience: Knowledge gained through practice experience · Consumer preference: Knowledge gained through life experience |
|
Information Source(s) |
Number of Sources |
· Source of information has credible experience |
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· Opinions are clearly stated |
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· Evidence obtained is consistent |
|
Findings That Help You Answer the EBP Question |
Quality Rating for Clinical Practice Guidelines, Consensus, or Position Statements (Level IV) |
A High quality Material officially sponsored by a professional, public, or private organization or a government agency; documentation of a systematic literature search strategy; consistent results with sufficient numbers of well-designed studies; criteria-based evaluation of overall scientific strength and quality of included studies and definitive conclusions; national expertise clearly evident; developed or revised within the past five years. B Good quality Material officially sponsored by a professional, public, or private organization or a government agency; reasonably thorough and appropriate systematic literature search strategy; reasonably consistent results, sufficient numbers of well-designed studies; evaluation of strengths and limitations of included studies with fairly definitive conclusions; national expertise clearly evident; developed or revised within the past five years. C Low quality or major flaw Material not sponsored by an official organization or agency; , poorly defined, or limited literature search strategy; no evaluation of strengths and limitations of included studies; insufficient evidence with inconsistent results; conclusions cannot be drawn; not revised within the past five years. |
Quality Rating for Organizational Experience (Level V) |
A High quality
Clear aims and objectives; consistent results across multiple settings; formal quality improvement or financial evaluation methods used; definitive conclusions; consistent recommendations with thorough reference to scientific evidence. B Good quality Clear aims and objectives; formal quality improvement or financial evaluation methods used; consistent results in a single setting; reasonably consistent recommendations with some reference to scientific evidence. C Low quality or major flaws Unclear or missing aims and objectives; inconsistent results; poorly defined quality; improvement/financial analysis method; recommendations cannot be made. |
Quality Rating for Case Report, Integrative Review, Literature Review, Expert Opinion, Community Standard, Clinician Experience, Consumer Preference (Level V) |
A High quality
Expertise is clearly evident, draws definitive conclusions, and provides scientific rationale; thought leader in the field. B Good quality Expertise appears to be credible, draws fairly definitive conclusions, and provides logical argument for opinions. C Low quality or major flaws Expertise is not discernable or is dubious; conclusions cannot be drawn. |
RESEARCH Open Access
Telecoaching plus a portion control plate
for weight care management: a
randomized trial
Jill M. Huber1, Joshua S. Shapiro2, Mark L. Wieland1, Ivana T. Croghan1, Kristen S. Vickers Douglas3,
Darrell R. Schroeder4, Julie C. Hathaway5 and Jon O. Ebbert1,6*
Abstract
Background: Obesity is a leading preventable cause of death and disability and is associated with a lower health-
related quality of life. We evaluated the impact of telecoaching conducted by a counselor trained in motivational
interviewing paired with a portion control plate for obese patients in a primary care setting.
Methods: We conducted a randomized, clinical trial among patients in a primary care practice in the midwestern
United States. Patients were randomized to either usual care or an intervention including telecoaching with a
portion control plate. The intervention was provided during a 3-month period with follow-up of all patients
through 6 months after randomization. The primary outcomes were weight, body mass index (BMI),waist
circumference, and waist to hip ratio measured at baseline, 6, 12, 18, and 24 weeks. Secondary outcomes included
measures assessing eating behaviors, self-efficacy, and physical activity at baseline and at 12 and 24 weeks.
Results: A total of 1,101 subjects were pre-screened, and 90 were randomly assigned to telecoaching plus portion
control plate (n = 45) or usual care (n = 45). Using last-value carried forward without adjustment for baseline
demographics, significant reductions in BMI (estimated treatment effect -0.4 kg/m2, P = .038) and waist to hip ratio
(estimated treatment effect -.02, P = .037) at 3 months were observed in the telecoaching plus portion control plate
group compared to usual care. These differences were not statistically significant at 6 months. In females, the
telecoaching plus portion control plate intervention was associated with significant reductions in weight and BMI
at both 3 months (estimated treatment effect -1.6 kg, P = .016 and -0.6 kg/m2, P = .020) and 6 months (estimated
treatment effect -2.3 kg, P = .013 and -0.8 kg/m2, P = .025). In males, the telecoaching plus portion control
intervention was associated with a significant reduction in waist to hip ratio at 3 months (estimated treatment
effect -0.04, P = .017), but failed to show a significant difference in weight and BMI.
Conclusion: Telecoaching with a portion control plate can produce positive change in body habitus among obese
primary care patients; however, changes depend upon sex.
Trial registration: ClinicalTrials.gov NCT02373878, 13 February 2015. https://clinicaltrials.gov/ct2/show/
NCT02373878.
Keywords: Obesity, Telecoaching, Portion control plate, Primary care, Patient-centered medical home
* Correspondence: Ebbert.Jon@mayo.edu
1Division of Primary Care Internal Medicine, Department of Medicine,
Rochester, MN 55905, USA
6Mayo Clinic, 200 First Street Southwest, Rochester, MN 55905, USA
Full list of author information is available at the end of the article
TRIALS
© 2015 Huber et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License
(http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium,
provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://
creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Huber et al. Trials (2015) 16:323
DOI 10.1186/s13063-015-0880-1
http://crossmark.crossref.org/dialog/?doi=10.1186/s13063-015-0880-1&domain=pdf
https://clinicaltrials.gov/ct2/show/NCT02373878
https://clinicaltrials.gov/ct2/show/NCT02373878
mailto:Ebbert.Jon@mayo.edu
http://creativecommons.org/licenses/by/4.0
http://creativecommons.org/publicdomain/zero/1.0/
http://creativecommons.org/publicdomain/zero/1.0/
Background
Obesity is a leading cause of preventable death and dis-
ability in the United States [1], a lower health-related qual-
ity of life [2], and contributes to chronic disease burdens
of hypertension, hyperlipidemia, osteoarthritis, cancer,
diabetes mellitus, and sleep apnea. Medical costs for
people who are obese are $1429 higher per year than
those of normal weight and total $147 billion annually [3].
The American Medical Association, American College
of Physicians, and the United States Preventive Services
Task Forces have published guidelines that define obesity
as a disease and recommend intensive physician-patient
behavioral modification for obese patients [1, 2, 4–7].
However, lack of physician disease recognition, time, and
skills make implementation of these recommendations
unlikely [8–10]. Furthermore, existing trials of obesity
counseling by primary care physicians have demon-
strated mixed results [11–13]. A large meta-analysis of
primary care diet and physical activity interventions re-
cently showed that the most effective interventions
utilize a combined lifestyle approach and require inten-
sive patient contact spread over several months [14].
This intensive patient contact may be best achieved by
utilizing allied healthcare providers as has been demon-
strated with successful clinical weight loss interventions
administered by a registered dietician [15, 16], a medical
assistant [17], or by a counselor using motivational inter-
view techniques [18].
Recently, there has also been an increased interest in
maintaining patient contact via information technology
such as email, telephone, and online messaging [19, 20].
Telephone counseling has been associated with positive
behavior changes such as increasing physical activity and
improving nutrition [21] while also being associated with
significant weight loss [16]. Additionally, group tele-
phone counseling via conference calls conducted by
counselors has also demonstrated promising results [22].
Although telecoaching has proven efficacious, it remains
poorly understood how it lends itself to a combined life-
style approach in weight loss interventions.
We conducted a pilot study of a weight loss interven-
tion utilizing telecoaching conducted by a counselor
trained in motivational interviewing for obese patients in
a primary care setting. Additionally, patients received a
portion control plate, which previously had been shown
to be helpful for monitoring food portions [23]. We
hypothesized that an intervention utilizing a combined
lifestyle approach to weight management would be feas-
ible and result in significant weight loss.
Methods
Study overview
We conducted a randomized clinical trial evaluating the
effectiveness of telecoaching combined with a portion
control plate. Telecoaching was provided during a
3-month intervention period with follow-up through
6 months after randomization. The primary study out-
comes were weight reduction, BMI, waist circumference,
and waist to hip ratio, measured at 6, 12, 18, and 24 weeks.
Secondary outcomes included measures assessing eating
behaviors, self-efficacy, and physical activity collected at
12 and 24 weeks. Enrollment took place between May
2011 and June 2012. This trial was performed in accord-
ance with the CONSORT guidelines for randomized con-
trolled trials (see Additional file 1 and 2 for details).
Setting
The study was conducted at a large academic primary
care practice in the Midwestern United States. The
practice provides primary care to approximately
130,000 patients.
Study participants
Participants were eligible for the study if they were be-
tween the ages of 18 and 55 years with a body mass
index ≥30 and ≤39.9 kg/m2 (obesity class I and II) and
were motivated to pursue weight loss. We selected the
upper age limit of 55 years because we were most inter-
ested in determining if the intervention was effective in
a population at risk for complications related to over-
weight and obesity who may not yet be suffering these
consequences. Participants were excluded if they had a
significant health condition (for example, recent myocar-
dial infarction, untreated hypertension, bipolar disorder,
etcetera), had undergone bariatric surgery, were preg-
nant, or were utilizing an investigational weight loss
medication. This study was approved by the Institutional
Review Board of Mayo Clinic prior to patient contact:
reference number 11-001395.
Study enrollment
Study personnel performed a limited chart review based
on BMI and age eligibility criteria to identify primary
care patients eligible for the study. For potentially eli-
gible participants who had an upcoming appointment,
their primary care providers were alerted of their eligibil-
ity. The study was then introduced at the clinic visit with
referral of those interested to study personnel for con-
sideration of enrollment. For eligible participants who
did not have an upcoming appointment in primary care,
a recruitment letter was sent with instructions on how
to contact study personnel for enrollment. All interested
eligible patients underwent initial pre-screening via tele-
phone by study personnel. Potential subjects then met
with study personnel to review the study protocol in de-
tail. Informed consent was obtained from all participants
(or next of kin) prior to enrolment in the trial.
Huber et al. Trials (2015) 16:323 Page 2 of 9
Randomization
A computer generated randomization schedule was cre-
ated using blocks of size 4 to ensure that treatment as-
signment was balanced across groups over the course of
the enrollment period. Using this randomization sched-
ule, individuals who did not have any subject contact for
the present study prepared randomization envelopes,
which were labeled according to subject ID number and
contained an index card indicating the treatment assign-
ment for the given subject. At the time of enrollment, a
subject was assigned the next sequential subject ID
number, and the appropriate sealed envelope was
opened to reveal the subject’s randomized treatment as-
signment. The authors were blinded to randomization.
The interventionist was not blinded to study assignment
given the nature of the intervention Additional files 3.
Intervention
In the intervention group, participants received a por-
tion control plate with instructions on use along with
telecoaching. Telecoaching involved telephone counsel-
ing on lifestyle modification from a single master’s level
female counselor trained in motivational interviewing
and wellness coaching.
The wellness coach proactively contacted the partici-
pants every 2 weeks for 3 months for a total of seven
phone calls. Motivational interviewing was the frame-
work for intervention delivery. Motivational interviewing
is a directive, patient-centered counseling style for elicit-
ing behavior change by helping patients to explore and
resolve ambivalence [24], with efficacy data for weight
loss in face-to-face clinical settings [25]. The focus of
the discussion was an improvement in lifestyle by identi-
fying barriers to incorporating healthy behaviors and
problem solving to overcome these, collaborative goal
setting, and progress toward patient-identified behavior
change goals. Specific strategies were utilized to focus
on improving diet and physical activity. These included,
giving information about the “500 calorie challenge,”
which is a strategy for reducing daily caloric intake by
500 calories. Additionally, recommendations were given
for incorporating routine self-weighing, tools for moni-
toring and documenting intake, and regular physical
activity with a goal of 150 min of moderate intensity
exercise per week.
Average phone call duration was approximately 20 mi-
nutes with the first and final calls being slightly longer.
The format of the coaching session was a “check in,” fo-
cusing on progress towards behavior change goals from
the previous call, discussion around successes and bar-
riers, problem solving, and collaboratively setting an ac-
tion plan for the upcoming 2 weeks. The usual care
group received institutional pamphlets on healthy eating
and exercise habits.
Study measures
Participants in both groups were evaluated in the clinic
at baseline and at 6, 12, 18, and 24 weeks to obtain
weight, BMI, waist circumference, and waist to hip ratio.
Participants also completed measures assessing eating
behaviors and physical activity at baseline and at 12 and
24 weeks.
The primary outcomes included body weight, BMI,
waist circumference, and waist to hip ratio. Body weight
was measured by a digital scale calibrated on a regular
basis using certified weights. Participants were measured
with their shoes and heavy outer garments removed and
pockets emptied. The BMI was calculated from mea-
sured height and weight (kg/height [meters]2). Waist
circumference measurement was standardized utilizing a
measuring tape held in the horizontal plane around the
abdomen at the iliac crest and taken at the end of a nor-
mal expiration with the tape snug and not compressing
the skin. Waist to hip ratio was calculated by dividing
the waist circumference measurement by the measure-
ment obtained at the narrowest part of the hips.
Secondary outcomes included physical activity level,
dietary changes, self-efficacy, social support, and con-
structs of behavioral change. Physical activity was mea-
sured via two separate surveys. The Seven-Day Physical
Activity Recall [26] is a five-item assessment of physical
activity over the previous 7 days that characterizes sleep,
light, moderately hard, hard, and very hard activity.
Results are reported as total daily energy expenditure
(kcal/day). The International Physical Activity Question-
naire (IPAQ) [27] is a seven-question self-report meas-
ure of physical activity that has been shown valid and
repeatable in very diverse settings throughout 12 dif-
ferent countries. The questionnaire assesses frequency
and duration of walking, moderate-intensity activity,
and vigorous-intensity activity over a 1-week period,
with results reported in total Metabolic Equivalents
(METs) per week.
Dietary changes were measured via the Food Frequency
Questionnaire (FFQ), which is a self-administered food
questionnaire that asks the participant to report frequency
of consumption and portion size of 125 common food
items over a given time [28, 29]. This was administered
electronically.
The Eating Inventory [30] measured dietary restraint,
disinhibition, and hunger. Research has demonstrated
that scores can improve following obesity treatment, and
that scores predict outcome to obesity treatment [31].
Additionally, we utilized the Weight Efficacy Life-Style
Questionnaire (WEL) [32], which is a 20-item eating
self-efficacy scale consisting of a total score and five situ-
ational factors: negative emotions, availability, social
pressure, physical discomfort, and positive activities.
Participants rated their confidence in being able to
Huber et al. Trials (2015) 16:323 Page 3 of 9
successfully resist the urge to eat using a 10-point scale
ranging from 0 (not confident) to 9 (very confident)
[33]. Improvements in eating self-efficacy have been
associated with both greater weight loss as well as im-
proved performance in weight control behaviors during
intensive treatments [34]. We measured social support
with the Weight Management Support Inventory
(WMSI) [35], which assesses four dimensions of social
support (emotional, instrumental, informational, and ap-
praisal). The WMSI allows measurement of baseline
levels of support for weight management and verifies
changes in support via intervention. Finally, we mea-
sured commonly accepted constructs of behavioral
change with the Neis Behavior Change Scale (NEIS),
which is a 16-item questionnaire that evaluates three
theoretical constructs: (a) goal setting, (b) restructuring
plans, and (c) relapse prevention and maintenance.
These constructs have previously been identified as im-
portant aspects of interventions, and this scale has been
shown to have both internal and test-retest reliability in
assessing these [36].
Sample size and statistical analysis
This randomized trial was a pilot study, and a power
analysis to determine number of subjects needed for
statistical significance was not performed. Data are pre-
sented as mean ± SD or median (25th, 75th) for continu-
ous variables and frequency percentages for nominal
variables. Body size measurements at 3 and 6 months
were compared between groups using analysis of covari-
ance. For these models, the follow-up measurement was
the dependent variable, treatment group was the inde-
pendent variable and the baseline value of the measure-
ment was included as the covariate. These analyses were
performed using only subjects with complete data, and
using the approach of last value carried forward. For
these analyses, the results are summarized by presenting
the estimated treatment effect and corresponding 95 %
confidence interval. From initial comparisons of baseline
characteristics, the distribution of males and females was
found to differ significantly between treatment groups.
For this reason, post-hoc analyses were performed
which included sex as a covariate, and supplemental
analyses were performed separately for males and fe-
males. Due to skewed distributions, the change from
baseline to 3 months for secondary outcomes was
compared between groups using the rank sum test. In
all cases, two-sided tests were performed with P
values ≤ .05 considered statistically significant.
Results
Enrollment and follow-Up
Of the 1101 subjects screened, 106 passed a telephone
pre-screen. Of these 106, 92 attended a consent/screen
visit, and 90 were randomly assigned to telecoaching
plus portion control plate (n = 45) or usual care (n = 45)
(Table 1). Although the majority of both treatment
groups were female, the percentage of males in the tele-
coaching plus portion control group was significantly
lower than that for the usual care group (16 % versus
36 %; P = .030). Other baseline characteristics were simi-
lar between groups. Fourteen subjects discontinued the
study, as they were not present for the 6-month follow-
up visit resulting in an overall study completion rate of
84 % (82 % for telecoaching plus portion control, 87 %
for usual care).
Body measurement outcomes
In the primary analysis using last-value carried forward
without adjustment for baseline demographics, significant
reductions in BMI (estimated treatment effect -0.4 kg/m2,
P = .038) and waist to hip ratio (estimated treatment
effect -.02, P = .037) at 3 months were observed in the
telecoaching plus portion control plate group com-
pared to usual care (Table 2). These differences were
not statistically significant at 6 months.
Because the distribution of males and females was found
to differ significantly between treatment groups, post-hoc
analyses with last-value carried forward were performed
with sex included as a covariate. For the endpoints of
weight and BMI, significant sex-by-treatment interaction
effects were detected at both 3 months (P = .027 and
P = .049) and 6 months (P = .020 and P = .044). Given
these significant sex-by-treatment interaction effects, add-
itional analyses were performed to assess all endpoints
separately for males and females. For females, the tele-
coaching plus portion control intervention was associated
with significant reductions in weight and BMI at both
3 (estimated treatment effect -1.6 kg, P = .016 and-
0.6 kg/m2, P = .020) and 6 months (estimated treat-
ment effect -2.3 kg, P = .013 and -0.8 kg/m2, P = .025).
For males, the telecoaching plus portion control inter-
vention was associated with a significant reduction in
waist to hip ratio at 3-months (estimated treatment
effect -0.04, P = .017).
Changes in activity, diet and theory-based measures
We observed no significant overall difference in physical
activity, dietary quality, or theory-based measures be-
tween the intervention and usual care groups. Among
women, significant differences were observed for the
change in METs per week based on the IPAQ (median
change from baseline +778 versus -257 for telecoaching
plus portion control versus usual care, respectively;
P = .011), change in WEL total score (+12.5 versus -1.5,
P = .041) and change in NEIS restructuring plans (+1.0
versus -1.0, P = .012) (Table 3).
Huber et al. Trials (2015) 16:323 Page 4 of 9
Discussion
We observed that use of telecoaching with a portion con-
trol plate among obese primary care patients can produce
positive change in body habitus and that changes
depended upon sex. For women, the intervention was as-
sociated with weight loss maintained at 6 months as well
as corresponding positive behavioral changes as assessed
by the secondary outcome measures.
We observed an improvement in the waist to hip ratio
at 3 months among the men in our study. Among men,
waist to hip ratio may actually be a better predictor of
mortality risk than weight loss [37, 38]. Interventions such
as ours that have a clinically significant beneficial impact
on waist to hip ratio may therefore potentially have a clin-
ically significant impact on mortality risk in men.
A number of studies have recently highlighted possible
differences between males and females in weight loss tri-
als. Historically, men have been underrepresented in
weight loss trials and many trials have enrolled females
exclusively [39]. In the past, this has made it difficult to
compare accurately the magnitude of effect in men ver-
sus women. A recent systematic review comparing
weight loss interventions through diet and exercise
found that men are generally more successful than
women in weight-loss trials, but found no evidence that
men and women should adopt different weight loss
strategies [40].
To our knowledge, specific sex-based determinants
influencing response to lifestyle intervention by motiv-
ational interviewing and setting behavior change goals
have not been well characterized. However, our findings
imply that telephone-based, motivational interview-
based interventions in a primary care practice may be
more successful among women.
The positive change in the NEIS and the WEL scores
among the female participants who received telecoach-
ing plus a portion control plate could indicate that these
participants experienced improvements in eating self-
efficacy as well as improvements in some constructs of
Table 1 Baseline demographic characteristics
Telecoaching +
portion control
Usual care
(N = 45) (N = 45)
Age, years
mean ± SD 48.3 ± 12.3 47.4 ± 14.1
range 20 to 65 18 to 70
Sex, no. (%)
Male 7 (16) 16 (36)
Female 38 (84) 29 (64)
Race/ethnicity, no. (%)
White, non-Hispanic 43 (96) 41 (91)
Other 2 (4) 4 (9)
Marital status, no. (%)
Married/living as married 26 (58) 34 (76)
Separated/divorced 2 (4) 4 (9)
Never married 13 (29) 7 (16)
Widowed 4 (9) 0 (0)
Number of people in
household, no. (%)
1 11 (24) 7 (16)
2 13 (29) 21 (47)
3 7 (16) 6 (13)
4 or more 14 (31) 11 (24)
Education, no. (%)
Less than high school 1 (2) 0 (0)
High school graduate 8 (18) 3 (7)
Some college 17 (38) 17 (38)
4-year college degree
or more
19 (42) 25 (56)
Work status, no. (%)
Full time 34 (76) 29 (66)
Part time 6 (13) 7 (16)
Unemployed 2 (4) 0 (0)
Retired 1 (2) 8 (18)
Current tobacco use, no. (%) 4 (9) 1 (2)
Diabetes, no. (%) 3 (7) 4 (9)
Prior treatment fordepression,
no. (%)
14 (31) 13 (29)
Prior treatment for alcoholism,
no. (%)
2 (4) 2 (4)
Weight,, mean ± SD, kg 99.6 ± 14.0 103.6 ± 18.9
BMI, mean ± SD 36.5 ± 4.2 36.1 ± 3.9
Waist, mean ± SD, cm 108.6 ± 9.3 112.4 ± 13.3
Waist-hip ratio, mean ± SD 0.88 ± 0.10 0.91 ± 0.11
FFQ, total calories,
median (25th, 75th) 2271 (1531, 3054) 2366 (1865, 3725)
Table 1 Baseline demographic characteristics (Continued)
IPAQ, total METs,
median (25th, 75th) 1760 (998, 4666) 1440 (680, 4596)
WEL, total score,
median (25th, 75th) 129 (110, 139) 116 (95, 136.5)
Nies Behavior Change, median (25th, 75th)
Goal setting 20.0 (17.5, 23.0) 20.0 (17.5, 24.0)
Restructuring plans 14.0 (13.0, 15.0) 14.0 (13.0, 16.0)
Relapse prevention 18.0 (16.0, 21.0) 18.5 (15.0, 21.0)
BMI body mass index (calculated as weight in kilograms divided by height in
meters squared), FFQ Food Frequency Questionnaire, IPAQ International
Physical Activity Questionnaire, WEL Weight Efficacy Life-Style Questionnaire
Huber et al. Trials (2015) 16:323 Page 5 of 9
behavioral change. Specifically, the significantly increased
scores of the NEIS behavior change construct of restruc-
turing indicates that these participants would be more
comfortable restructuring their weight loss plan if success
is not immediately achieved. Setting weight loss goals can
have both positive as well as negative effects, and an
increase in the construct of restructuring in behavioral
change indicates a necessary skill in overcoming setbacks
in behavioral change. Although the telecoaching interven-
tion was not primarily focused on eating self-efficacy or
restructuring, these appeared to be positive changes
related to the overall effects of the intervention.
The strengths of this study include a randomized de-
sign and assessment of an intervention that is feasible in
a primary care clinic. Telecoaching allows the behavioral
interventions and frequent patient contact necessary to
Table 2 Body size change from baseline to 3 and 6 months, overall and according to sex
Change from baseline
Telecoaching + portion
control
Usual care Complete case estimated treatment
effect
Last value carried forward estimated treatment
effect
N Mean ± SD N Mean ± SD Est (95 % C.I.) P* Est (95 % C.I.) P value*
All Subjects
3-months
Weight, kg 38 −2.2 ± 3.1 40 −1.0 ± 2.0 −1.2 (-2.4, -0.1) 0.045 −0.9 (-1.9, +0.1) 0.091
BMI, kg/m2 38 −0.9 ± 1.2 40 −0.3 ± 0.7 −0.5 (-1.0, -0.1) 0.020 −0.4 (-0.8, -0.0) 0.038
Waist, cm 38 −3.2 ± 3.6 39 −1.9 ± 2.6 −1.3 (-2.7, +0.1) 0.072 −0.9 (-2.2, +0.4) 0.180
Waist-hip ratio 38 −0.02 ± 0.05 39 −0.00 ± 0.03 −0.02 (-0.04, -0.00) 0.037 −0.02 (-0.04, -0.00) 0.037
6-months
Weight, kg 37 −2.6 ± 4.4 39 −1.1 ± 3.7 −1.5 (-3.3, +0.4) 0.118 −1.0 (-2.6, +0.6) 0.225
BMI, kg/m2 37 −1.0 ± 1.7 39 −0.4 ± 1.3 −0.7 (-1.4, -0.1) 0.038 −0.5 (-1.1, +0.1) 0.093
Waist, cm 36 −4.1 ± 6.1 39 −2.8 ± 4.1 −1.4 (-3.8, +0.9) 0.240 −1.1 (-3.2, +0.9) 0.282
Waist-hip ratio 36 −0.02 ± 0.07 39 −0.00 ± 0.05 −0.02 (-0.05, +0.00) 0.083 −0.02 (-0.05, +0.00) 0.083
Women
3-months
Weight, kg 33 −2.5 ± 3.1 26 −0.7 ± 2.1 −1.9 (-3.2, -0.6) 0.007 −1.6 (-2.8, -0.3) 0.016
BMI, kg/m2 33 −1.0 ± 1.2 26 −0.3 ± 0.8 −0.7 (-1.2, -0.2) 0.012 −0.6 (-1.1, -0.1) 0.020
Waist, cm 33 −3.5 ± 3.6 25 −1.9 ± 2.9 −1.6 (-3.4, +0.1) 0.074 −1.4 (-3.0, +0.2) 0.083
Waist-hip ratio 33 −0.01 ± 0.05 25 0.00 ± 0.03 −0.01 (-0.03, +0.01) 0.350 −0.01 (-0.03, +0.01) 0.295
6-months
Weight, kg 33 −2.9 ± 4.5 25 −0.3 ± 3.4 −2.9 (-4.8, -1.0) 0.004 −2.3 (-4.0, -0.5) 0.013
BMI, kg/m2 33 −1.1 ± 1.7 25 −0.2 ± 1.4 −1.0 (-1.8, -0.2) 0.014 −0.8 (-1.5, -0.1) 0.025
Waist, cm 33 −4.0 ± 6.2 25 −2.0 ± 4.1 −2.0 (-4.8, +0.8) 0.172 −1.7 (-4.2, +0.8) 0.199
Waist-hip ratio 33 −0.02 ± 0.07 25 0.00 ± 0.05 −0.01 (-0.04, +0.02) 0.428 −0.01 (-0.04, +0.01) 0.371
Men
3-months
Weight, kg 5 −0.0 ± 2.4 14 −1.4 ± 1.8 +1.4 (-0.6, +3.3) 0.190 +1.3 (-0.3, +2.8) 0.135
BMI, kg/m2 5 −0.0 ± .08 14 −0.4 ± 0.6 +0.4 (-0.2, +0.9) 0.206 +0.4 (-0.1, +0.9) 0.102
Waist, cm 5 −1.5 ± 3.2 14 −2.0 ± 2.1 +0.3 (-2.0, +2.7) 0.785 +0.9 (-1.6, +3.4) 0.501
Waist-hip ratio 5 −0.04 ± 0.05 14 −0.00 ± 0.04 −0.04 (-0.07, -0.00) 0.037 −0.04 (-0.07, -0.01) 0.017
6-months
Weight, kg 4 −0.2 ± 3.5 14 −2.4 ± 4.0 +2.4 (-1.3, +6.1) 0.227 +2.3 (-0.5, +5.1) 0.122
BMI, kg/m2 4 −0.1 ± 1.1 14 −0.7 ± 1.1 +0.6 (-0.5, +1.7) 0.281 +0.7 (-0.1, +1.5) 0.098
Waist, cm 3 −6.2 ± 3.6 14 −4.0 ± 4.0 −2.4 (-6.6, +1.8) 0.286 −0.2 (-3.8, +3.4) 0.902
Waist-hip ratio 3 −0.03 ± 0.06 14 0.00 ± 0.06 −0.03 (-0.09, +0.03) 0.338 −0.04 (-0.08, +0.00) 0.077
*Treatment effects were estimated using analysis of covariance (ANCOVA). For these analyses, the follow-up measurement was the dependent variable, treatment
group was the independent variable and the baseline value of the measurement was included as the covariate
Huber et al. Trials (2015) 16:323 Page 6 of 9
guide weight loss, and may utilize resources more effi-
ciently than frequent clinic visits. The collaborative care
model engages nonphysician members of the medical
team. Minimal exclusion criteria of participants show
that the intervention is successful primarily for obese
women representative of those patients routinely seen in
primary care clinics in regards to age, comorbidities, and
baseline nutrition and physical activity status; however,
generalizability is limited in regards to ethnicity, as a
majority of participants was Caucasian.
Our study has limitations. First, we were limited by a
relatively small sample size, low enrollment of males,
and a random imbalance of males. We anticipated
randomization would result in an even balance and did
not stratify in anticipation of an imbalance. In addition,
our study is limited by underrepresentation of minority
populations who have higher rates of obesity [7].
Differences in patient contact time of the intervention
existed between the two groups. Differences in contact
time may potentially confound the assessment of efficacy
of the telecoaching plus portion control plate interven-
tion compared to a control intervention if contact time
influenced outcome. Our study was not designed to
assess the influence of contact time on our outcomes.
Furthermore, we did not record the counseling sessions,
nor did we require the counselors to follow a predefined
script. This may hinder reproducibility but may increase
generalizability.
Available evidence suggests that average weight losses
of 2.5 kg to 5.5 kg at ≥2 years achieved with lifestyle
intervention reduces the risk of diabetes by 30 % to 60 %
[41]. Among women, we observed a significant weight
loss of 2.9 kg in the complete case analysis at 6 months.
We did not examine weight maintenance beyond this
interval. Measures of physical activity and exercise inten-
sity included the Seven Day Physical Activity Recall and
the IPAQ. Although we did observe a significant differ-
ence in METS/week in the intervention group, these
self-reporting tools are not the most reliable measures of
physical activity. Finally, while the portion control plate
was used as a tool to facilitate discussion with the tele-
coach, the study was not designed to isolate the relative
impact of the plate versus the telecoaching intervention
components.
Table 3 Secondary outcomes change from baseline to 3 months, overall, and according to sex
Telecoaching + portion control Usual care
N median (25th, 75th) N median (25th, 27th) P value*
All Subjects
FFQ, total calories 38 −796, (-1303, -196) 41 −694 (-1371, -303) 0.662
IPAQ, total METs/week 39 +757 (-720, +2104) 40 +61 (-1071, +790) 0.090
WEL, total score 39 +12.0 (-4.0, +21.0) 40 +1.0 (-18.5, +16.25) 0.070
NEIS: Goal setting 39 +1.0 (-1.0, +3.0) 40 −1.0 (-2.0, +1.0) 0.027
NEIS: Restructuring plans 37 +1.0 (0.0, +1.0) 40 −1.0 (-2.0, +0.75) 0.006
NEIS: Relapse prevention 39 +2.0 (0.0, +3.0) 39 0.0 (-1.0, +3.0) 0.066
Women
FFQ, total calories 33 −745 (-1233, -177) 26 −471 (-1224, -241) 0.598
IPAQ, total METs/week 34 +778 (-479, +2158) 26 −257 (-2690, +565) 0.011
WEL, total score 34 +12.5 (-4.0, +21.0) 26 −1.5 (-17.5, +14.0) 0.041
NEIS: Goal setting 34 +1.0 (-0.25, +3.0) 26 0.0 (-2.0, +0.25) 0.104
NEIS: Restructuring plans 32 +1.0 (0.0, +1.0) 26 −1.0 (-2.0, +0.25) 0.012
NEIS: Relapse prevention 34 +2.0 (+0.75, +3.75) 25 0.0 (-1.5, +3.5) 0.125
Men
FFQ, total calories 5 −1316 (-2512, -607) 15 −707 (-1864, -342) 0.485
IPAQ, total METs/week 5 −5280 (-8611, +3598) 14 +480 (-248, +1248) 0.431
WEL, total score 5 +2.0 (-15.0, +31.0) 14 +6.5 (-23.0, +22.0) 0.963
NEIS: Goal setting 5 +1.0 (-3.5, +2.5) 14 −1.5 (-2.0, +1.0) 0.811
NEIS: Restructuring plans 5 +1.0 (−2.5, +15.0) 14 0.0 (−1.0, +1.0) 0.317
NEIS: Relapse prevention 5 −2.0 (−2.5, +1.5) 14 0.0 (−1.25, +1.25) 0.543
FFQ Food Frequency Questionnaire, IPAQ International Physical Activity Questionnaire, NEIS Neis Behavior Change Scale, WEL Weight Efficacy
Life-Style Questionnaire
*Wilcoxon rank sum test
Huber et al. Trials (2015) 16:323 Page 7 of 9
Conclusion
The recent AHA/ACC Obesity guidelines support the
use of electronically delivered, including telephone,
primary care weight loss programs focused on lifestyle
interventions facilitated by a trained interventionist.
This study supports telecoaching plus a portion con-
trol plate as a promising weight management strategy
for obese women in primary care. Future research
should evaluate whether this weight loss is maintained
over time in these programs
Additional files
Additional file 1: CONSORT Checklist. (DOC 217 kb)
Additional file 2: TIDieR Checklist. (DOC 62 kb)
Additional file 3: CONSORT Diagram. (JPEG 187 kb)
Abbreviations
BMI: body mass index; IPAQ: The International Physical Activity Questionnaire;
METs: metabolic equivalents; FFQ: Food Frequency Questionnaire;
WEL: Weight Efficacy Life-Style Questionnaire; WMSI: Weight Management
Support Inventory; NEIS: Neis Behavior Change Scale..
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
JMH designed the trial, obtained funding, oversaw the conduct of the study,
and drafted the initial draft of the manuscript. JSS interpreted the data and
provided critical revisions of the manuscript. MLW helped with study design,
interpretation of results, and writing. ITC coordinated the study, helped
draft the initial draft of the manuscript, and provided critical revisions of the
manuscript. KSV interpreted the data and provided critical revisions of the
manuscript. DRS helped with data acquisition, analyzed the data and
provided critical revisions of the manuscript. JCH provided the study
interventions and provided critical revisions of the manuscript. JOE helped
design the trial, helped secure resources to fund the study, oversaw the
conduct of the study, mentored the principal investigator, helped draft the
manuscript, interpreted the data, and provided critical revisions of the
manuscript. All authors read and approved the final manuscript and agree
to be accountable for all aspects of the work.
Funding/support
This study was funded by the Mayo Clinic in Rochester, MN.
Author details
1Division of Primary Care Internal Medicine, Department of Medicine,
Rochester, MN 55905, USA. 2Division of Internal Medicine, Department of
Medicine, Rochester, MN 55905, USA. 3Department of Psychiatry and
Psychology, Mayo Clinic, Rochester, MN 55905, USA. 4Division of Biomedical
Statistics and Informatics, Department of Health Sciences Research, Mayo
Clinic, Rochester, MN 55905, USA. 5Patient Education and Consulting
Services, Mayo Clinic, Rochester, MN 55905, USA. 6Mayo Clinic, 200 First
Street Southwest, Rochester, MN 55905, USA.
Received: 27 April 2015 Accepted: 21 July 2015
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