Is Non-Adherence Unique to Weight-Loss? Predictors of Adherence to a Heart-Healthy Diet in Lean vs. Obese Individuals
Phase: NA
Conditions: Obesity, Overweight
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1 
 
Version Date: 4.24.2018 
 
Is non-adherence unique to weight loss? 
 Predictors of adherence to a heart-healthy diet in lean vs. obese individuals 
 
 
Principal Investigator: 
Marci E. Gluck, PhD* 
 
 
 
 
4212 N. 16th Street 
 
 
 
 
Phoenix, AZ   85016 
 
 
 
 
gmarci@mail.nih.gov  
 
 
 
 
 
Type:  
 
 
Clinical Trial: Intervention 
 
 
Associate Investigators: 
Jonathan Krakoff, MD* 
ODCRS, PECRB, NIDDK 
602-200-5217 
 
 
 
 
jkrakoff@mail.nih.gov 
Doug Chang, MD* 
 
Medical Advisory Investigator  
 
 
 
 
ODCRS, PECRB, NIDDK 
602-200-5312 
 
 
 
 
Douglas.chang2@nih.gov 
Susanne Votruba, PhD 
ODCRS, PECRB, NIDDK 
602-200-5336 
 
 
 
 
votrubas@mail.nih.gov 
Emma Stinson1  
 
ODCRS, PECRB, NIDDK  602-200-5328  
 
 
 
 
 
 
Emma.stinson.nih.gov 
 
Non-NIH Collaborators: 
Scott Engel, PhD 
 
Neuropsychiatric Research Institute (701) 365-4941 
 
 
 
 
 sengel@nrifargo.com 
Ross Crosby, PhD 
 
Neuropsychiatric Research Institute (701) 365-4926  
 
 
 
 
 rcrosby@nrifargo.com 
 
 
Estimated Duration of Study: 4 Years 
 
 
Start Date: 3/1/2013 
 
 
End Date: 2/28/2018  
 
 
 
 
Number and Type of Patient:  
Number 
Sex 
 
Age Range 
 
 
 
 
                      Volunteers 
150 
 
M/F 
 
> 18 
 
 

2 
 
 
 
Uses Ionizing Radiation? 
 
 
Yes 
Research indicated:  RSC Approval Number: 0158   Expiration Date: 
 
 
 
 
Requires IND/IDE?  
 
 
No 
 
Sponsor: 
 
 
 
 
None 
 
Uses “Durable Power of Attorney”  
No 
 
Study Location 
 
 
 
Clinical Research Unit, NIDDK Phoenix 
 
Multi-Institutional Project?  
 
No  
 
Expedited Review Request?  
 
No 
 
 

3 
 
 
TABLE OF CONTENTS                             
PRECIS 
 
5 
INTRODUCTION 
 
 6 
 
Obesity 
6 
 
Adherence   
6 
 
Predictors of Adherence 
7-9 
 
Assessment of Adherence 
9 
 
  
 
AIMS OF THE STUDY 
 
10 
HYPOTHESES 
 
10-11 
RESEARCH DESIGN 
AND METHODS 
 
11 
 
Subjects 
 11-12 
 
Inclusion/Exclusion Criteria 
 12-13 
 
Experimental Design 
 13 
 
             Screening Visit 
13 
 
             Baseline Visit 
14-20 
 
             Outpatient Visits 
20 
 
             Outpatient Adherence Measures 
21-23 
 

4 
 
 
 
Post-intervention Visit 
23 
 
Patient Monitoring 
23 
 
Data Analysis and Sample Size 
24-28 
BENEFITS 
 
29 
HUMAN SUBJECT 
PRECAUTIONS 
 
29 
 
Recruitment and Minority Participation 
29 
 
Safeguards for Subjects 
30 
 
Risks and Discomforts 
 30-32 
 
Disclosure of Medical Conditions 
 31 
 
Data and Safety Monitoring 
 32-34 
 
Research Use of Stored Samples 
 34 
 
Reimbursement 
 35-36 
TABLES 
 
 37-40 
REFERENCES 
SCORING SHEET 
 
 41 
42 
 

5 
 
 
PRECIS 
 
Adherence, or "sticking to your diet" is important for successful initial weight loss and 
keeping off the weight over the long term (1).  While early behavioral and dietary adherence 
have been associated with greater weight loss, sticking to a diet plan is difficult.  It is not clear if 
adherence to any diet plan (even one which does not produce weight loss) is hard or whether 
people who are overweight have more difficulty with adhering to diet plans compared to people 
who are relatively lean. 
 
 
The main aim of this study is to evaluate dietary adherence in 3 groups of individuals 
participating in a 6-week heart-healthy dietary intervention program.  Two groups [1. Lean (BMI 
< 25 kg/m²) and 2. Obese (BMI > 30 kg/m²)] will receive a heart-healthy diet designed to 
maintain their weight, and the third group [3. Obese] will be given a heart-healthy diet that is 
35% less than their daily calorie needs to lose weight.  Participants will attend one counseling 
session per week and will be contacted randomly 1x/week by study staff for completion of a 24-
hour dietary recall. They will complete daily food diaries and daily records using smart-phones. 
Prior to starting the assigned heart-healthy dietary intervention, participants will complete 
questionnaires that include questions about how motivated they are to follow a diet, lose weight, 
and change eating patterns.  These findings may help us understand what factors affect 
adherence, and help us design weight loss studies that improve people's ability to stick to diet 
interventions.     

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A. INTRODUCTION 
 
Obesity, defined by the NHLBI in 1998 (2) as a body mass index [BMI, in kg/m2] > 30, 
has become a medical epidemic in the US (3) , and is reaching pandemic proportions in most 
industrialized countries. Obesity is linked to a number of medical complications and is a leading 
cause of preventable death in America, contributing to over 150,000 excess deaths per year (4). 
At any given time of the year, between 15 and 35% of the adult population in the US is 
reportedly attempting to lose weight (5), yet, successful weight reduction and maintenance of 
weight loss remain elusive goals for many dieters. In fact, a relatively small maximum average 
weight loss is common even in very low calorie long-term treatments (6). This low treatment 
efficacy has been consistently observed, and while some do achieve weight loss success, only 
about 20% of overweight individuals maintain the weight loss (7). 
 
Adherence is defined as the “extent to which patients follow the instructions that are 
given to them for prescribed treatments" and is intended to be non-judgmental, a statement of 
fact rather than of blame of the patient, prescriber, or treatment (8)." Adherence is widely 
recognized as essential for achieving successful health outcomes yet non-adherence is the 
primary treatment barrier for most medical conditions.  A recent review found that rates of non-
adherence to treatment recommendations are 20%-40% for acute conditions, 30% to 60% for 
chronic conditions and 80% for prevention (9). Rates of non-adherence are substantially lower 
for lifestyle prescriptions and other more behaviorally demanding regimens (10).  Lack of 
adherence is a pervasive problem in clinical research. This lack of adherence to assigned 
interventions results in intention to treat analyses, which are biased towards null findings (11).   
For the treatment of obesity, there is a consensus that adherence is critical for successful 
initial weight loss and long term weight maintenance (1). Many studies have sought to identify 

7 
 
 
predictive demographic, psychosocial and behavioral characteristics that lead to weight loss 
success and successful weight loss maintenance. Age, income, marital status, ethnicity, 
employment status, previous dieting and weight history, dietary restraint, binge eating disorder, 
self-motivation and familial support, early weight loss success, and weight loss expectations are 
among the multitude of variables that have been studied (12).  Ultimately, poor adherence to 
calorie-reduced diets is one of the most plausible explanations for less than predicted weight loss 
in clinical studies.  In one review, Heymsfield and colleagues (6) concluded that participant 
adherence to the prescribed diet was the most likely explanation for the observed low efficacy of 
low-calorie diets, even after considering metabolic adaptations. Another recent study comparing 
four popular diets found a highly significant relationship between self-reported dietary adherence 
and weight loss, such that participants who scored in the top third of adherence lost an average of 
7% of body weight.  However, no single diet produced satisfactory adherence rates and the 
progressively decreasing mean adherence scores over time were practically identical among the 4 
diets (13). 
Factors predicting adherence have been moderately studied.  Cognitive skills, the 
underlying brain skills that make it possible for individuals to think, remember and learn, have 
recently been found to predict adherence (14-16). To examine neuropsychological and cognitive 
factors, traditional neuropsychological tests and measures designed to stimulate real-world 
situations (everyday cognitive measures) are often administered. Poor neurocognitive 
performance as measured by various neuropsychological performance tests, has been associated 
with decreased medication adherence in many clinical populations, including HIV, type II 
diabetes, older adults and individuals taking antidepressants (14).   

8 
 
 
The neuropsychological factors which are most predictive of medication non-adherence 
are poor executive functioning (necessary for goal-directed behavior e.g. ability to initiate/stop 
actions, monitor/change behavior, plan future behavior, anticipate outcomes, think abstractly), 
followed by working memory (availability of information needed to complete immediate and 
short-term tasks) and processing speed (a measure of learning and thinking efficiency) (14).  
Poor performance on an everyday problem solving questionnaire was associated with poorer 
self-reported medication adherence (14).  Moreover, problem-solving skills as measured by the 
Social Problem Solving Inventory partially mediated the relationship between treatment 
adherence and weight loss outcome in one recent study (15) and were significantly related to 
greater overall weight loss and long term weight loss maintenance in another study (16). In 
addition to evidence relating cognitive skills to adherence and weight loss, recent observations 
support a relationship between obesity status and performance on tests measuring decision-
making (17;18) (Iowa Gambling Task), problem solving and working memory (Wisconsin Card 
Sorting Task) and inhibition/attention (Go/No Go task; (19)).   
 
Personality is another factor significantly influencing health. The most common 
relationship between these variables is based on the Five Factor Model dimensions (FFM; (20)) - 
Neuroticism, Extraversion, Openness, Agreeableness and Conscientiousness, which are 
empirically derived clusters that capture the major axes of psychological and behavioral variation 
in humans (21;22).  FFM factors have been linked with many health-related behaviors and 
outcomes, including medication non-adherence.  One recent study found that neuroticism was 
the second strongest predictor of non-adherence to CPAP treatment for obstructive sleep apnea 
(23).  Previous studies have shown that medication non-adherence (24) as well as emotional and 
external eating behaviors (25) were most frequently associated with lower levels of 

9 
 
 
Conscientiousness and higher levels of Neuroticism.  However, no study to date has measured 
FFM with weight loss and/or dietary adherence.  
 
Successful weight management appears to require adherence across a wide variety of 
behaviors yet measuring adherence poses a significant problem. While objective behavioral 
measures are superior to subjective self-report measures, objective measures are often difficult to 
obtain.  Both early behavioral (e.g. attendance) and self-reported dietary adherence were 
predictors of changes in body weight, waist circumference and body fat, but for dietary 
adherence the magnitude of the effect was smaller (26).  It is widely accepted that adherence to 
weight management strategies is critical for successful weight loss and for long-term 
maintenance (1).  However, it is not clear whether problems with adherence occur more 
frequently with diets to promote weight loss versus weight maintenance, any diet prescription, 
and whether increased adiposity might in itself predispose to more difficulty with dietary and 
behavioral adherence. Our study aims to address these questions. 
 
 
Summary:  
Adherence is essential for initial weight loss and long-term weight maintenance. It is unclear 
whether adherence to dietary protocols differs between lean and obese individuals and whether 
non-adherence is specific to weight loss intervention diets (compared to weight maintenance 
diets).   Several predictors of adherence to medical treatments have been described, including 
associations with memory, problem solving, neuropsychological factors, personality traits and 
levels of motivation.  To understand how adherence may differ by adiposity and diet, we will 
examine differences in dietary adherence between lean and obese individuals and within the 
obese group between those prescribed a heart-healthy weight maintenance versus reduced calorie 

10 
 
 
diet. We will also examine predictors of adherence and the relationship between dietary 
adherence and weight loss.  
 
B. AIMS  
The primary goal of the current study is to determine whether or not there are differences in 
dietary adherence between lean and obese individuals and between two groups of obese 
individuals assigned different heart-healthy dietary prescriptions (weight maintaining diet 
[WMEN] vs. underfeeding [UF]).  Thus 3 groups will be compared:  
1. Lean WMEN   
2. Obese WMEN    
3. Obese UF 
The secondary aim is to: 
1. Examine predictors of adherence in general (e.g. motivation, self-efficacy, social support, 
personality traits, stress, neuropsychological/cognitive factors) 
 
C. HYPOTHESES 
The primary hypothesis for the study is that:  
1.  Adherence to a heart-healthy dietary intervention will be greatest in the lean WMEN group, 
followed by the WMEN obese group, and subsequently lowest in the UF obese group  
 
The secondary hypotheses are that: 
1. Within the UF group, individuals with higher adherence scores will lose more weight than 
those will lower scores 

11 
 
 
2. Poor performance on neuropsychological tests and problem solving questionnaires will be 
associated with decreased adherence across all groups  
3. Higher levels of neuroticism will be associated with lower levels of dietary adherence in all 3 
groups  
4. Higher levels of motivation and self-efficacy will predict greater adherence      
 
D. RESEARCH DESIGN & METHODS:  
Study Design: This is a study of lean and obese individuals undergoing a 6-week heart-healthy 
dietary intervention to examine dietary adherence. This design will allow us to determine 
whether or not levels of adherence are different between lean and obese individuals as well as 
between obese individuals receiving weight maintenance energy needs and those being underfed.   
Findings will also help us determine factors that influence dietary adherence.  
 
1. Subjects and Recruitment:  Non-diabetic individuals aged 18-70 years who are in good 
health and living in the greater Phoenix, AZ, metropolitan area are eligible to participate in this 
study. All subjects will be fully informed of the methods and risks of the study prior to giving 
written informed consent. Consent will be obtained by the principal investigator, co-
investigators, study physicians or physician assistant, who will be well informed about the 
protocol and the intervention. Subjects will also be specifically advised that the results of testing 
for drug usage will be filed in the medical record and would, therefore, be available as part of 
this record. We do not plan or anticipate the enrollment of non-English speaking subjects; 
however they are not excluded from participation either. Should a non-English speaking subject 
be eligible for enrollment, IRB approval will be obtained for use of the short form consent 

12 
 
 
process in the absence of a fully translated consent document as outlined in SOP 12.9.1, under 
the provisions of 45 CFR 46.117(b)(2). IRB approval will be obtained according to IRB 
guidance prior to obtaining informed consent from the potential study participant/s.  
 
Subject recruitment for this study will be through advertisement in local newspapers and 
through postings of the included flyers in various public places such as, but not limited to, 
libraries, public universities, hospitals, health clubs, and local health fairs.  Additionally, 
advertisements may be placed in some national newspapers or websites (Craigslist) to reach a 
wider audience, particularly for the lean, weight-maintaining arm of the study.  We aim to recruit 
50% women for each study arm.  A review of previous enrollment in our studies indicates that 
we typically have an even distribution of ethnic groups in our study samples (e.g. control versus 
treatment) even when the representation of ethnic categories is not equal.  Thus, we expect to   
have at least 33% of volunteers represented by African American, Hispanic, Asian, or Native 
American groups in each of our study arms. We plan to enroll 60 individuals and in order to 
enroll this many, we will likely need to screen many more. We have therefore set our anticipated 
number to be screened at 180, equal to three times the number enrolled.  For randomization, we 
will stratify the groups by gender and age, using a block design. 
 
2. Inclusion Criteria: 
1. BMI 
a. BMI > 30 kg/m2 for the obese WMEN and UF groups but body weight less than 350 
pounds to accommodate the DXA scanner 
b. BMI  25 kg/m2 (and BMI  18.5 kg/m2) for the lean WMEN group   

13 
 
 
2. Age >18 years. Minors under the age of 18 will be excluded because growth and pubertal 
issues are significant parameters that could affect our outcomes and also because the time 
requirements of the study are such that they would interfere with school schedules.  
Participants must be healthy, as determined by medical history, physical examination, 
and laboratory tests. 
3. Weight stable (± 2%) for last 3 months 
 
3. Exclusion Criteria: 
Candidates will be screened by phone to exclude those with BMI  26 kg/m2 and BMI   29 
kg/m2, significant health problems, including cancer, hypertension, diabetes, current and past 3-
month use of certain prescribed medications, especially those that could affect body weight, such 
as antidepressants and stimulants as well as smoking, or excess alcohol (> 3 drinks/d).  Women 
must not be pregnant or lactating, and be at least 1 year postpartum. Candidates with a history of 
psychotic disorder or hospitalization for psychiatric illness within the past 1 year will not be 
eligible. They will need to be weight stable for the past 3 months (±2%) and cannot be in 
treatment for obesity or currently receiving psychotherapy. Individuals who meet criteria 
according to the phone screen will be invited to come to the unit for a screening visit and their 
screening sheets are placed in a locked filing cabinet. Forms from potential volunteers who are 
ineligible are shredded.   
 
4. Experimental Design: 
Screening visit: Participants will arrive on the unit in a fasting state. Written informed consent 
will be obtained from the participant prior to any screening visits, study procedures or 

14 
 
 
treatments. The Principal Investigator or other designated qualified protocol investigators (listed 
on the protocol face page) will explain the study in language understandable to the subject.  
Because there are both clinical and technical areas that comprise this protocol, we will ensure 
both areas are fully addressed to the subjects by the research team with a clinical and technical 
member present during screening and consenting. We have designated on the protocol face page 
which investigators will obtain informed consent for this protocol. The investigator signature on 
the informed consent will be signed by the principal investigator or a designated clinical 
investigator. 
Sufficient time and opportunity will be given for discussion of the research as well as to 
answer any questions they may have, taking care to minimize or eliminate the perception of 
coercion or undue influence. The participant and the investigator will sign the current IRB-
approved informed consent document. A witness will also sign the consent document to attest 
only to the validity of the signature of the subject, not the validity or quality of the consent. This 
visit will then include:  
• 
Height, weight, and blood pressure measurements 
• 
A physical exam with a medical history component, including questions about 
medications and alcohol/substance use history.  Those meeting criteria for current substance 
abuse or dependence or current suicidal ideation will be excluded.   
• 
Research chemistry profile, including complete blood cell count, serum creatinine, ALT, 
AST, GGT, TSH, fasting plasma glucose and HbA1c.  If fasting glucose is 125 mg/dL or 
HbA1c > 6.5 and thus, suggestive of diabetes, volunteers will not be eligible for participation in 
this study and will be referred to their personal physician for follow-up care.     
• 
A urine sample for urinalysis, drug screen, nicotine test, and pregnancy test (if female) 

15 
 
 
• 
Brief meeting with a study counselor who will review the diet requirements and other 
protocol requirements such as the food pick-up schedule, phone contacts and self- monitoring 
requirements.  Physical activity will be assessed using the Physical Activity Recall (PAR) 
Questionnaire (Wilson et al., 1986).  
 
Following the screening visit, the study staff will meet to discuss the volunteer’s eligibility for 
participation in the study, as set forth by the inclusion and exclusion criteria (detailed above) and 
will contact him/her to set up the baseline visit if accepted into the study.   
 
The main goal of this study is to determine whether or not there are differences in dietary 
adherence between lean and obese individuals and between two groups of obese individuals 
assigned different heart-healthy dietary prescriptions (weight maintaining diet [WMEN] vs. 
underfeeding [UF]).  The experimental design is comprised of a 6-week outpatient heart-healthy 
dietary intervention with 2 clinic visits per week.  To achieve our study goals we will measure 
the following: 
Baseline Visit 1: 
1. 
Weight, waist, thigh circumferences & vitals 
2. 
Body composition using dual energy X-ray absorptiometry (DXA)  
3. 
Breakfast 
4. 
Behavioral Questionnaires  
5. 
Psychological performance tests  
6. 
Meet with study counselor to discuss weight maintenance diet instructions and study 
procedures 

16 
 
 
 
These parameters are described in detail below:  
• Body composition by dual-energy X-ray absorptiometry (DXA): DXA will be used to 
accurately measure body composition. DXA is an X-ray device which non-invasively assesses 
both skeletal density and soft tissue composition by region with a precision of <1% for bone and 
4-5% for soft tissue densities. Total body scan requires 10-50 minutes depending on the stature 
and thickness of the subject. The major limitation of the apparatus is the width of the scanning 
table. We validated the use of a half-body scan as an indicator of whole body composition in 
obese subjects who do not fit entirely on the scanning area. This half body method is valid for 
individuals weighing as much as 350 pounds (27). During the procedure, the subject is asked to 
lie flat on the table and to remain motionless, because the subject’s movement can compromise 
the precision of the measurement during the scan. Proper subject positioning is also important. 
Once the proper alignment is determined, the subject’s ankles and knees are loosely strapped to 
maintain the position. When the machine is turned on, a 188 mA current flows through the X-ray 
tube to produce X-rays. As the scan table arms move from the top of the subject’s head 
downward towards the subject’s feet, the shutter opens and a narrow beam of radiations projects 
upward through the table top and subject. After the scan, the arm clears the subject’s feet, the 
scanner stops, and the source shutter closes. The software then calculates body composition in 
grams of fat tissue and lean tissue and percentage of body fat. The operator remains in the room 
with the subject during the scan. 
• Psychological Assessment:  We will administer a battery of behavioral questionnaires and 
psychological performance tests to assess constructs related to adherence, eating-related 
behaviors, personality and additional psychopathology. These assessments will be used to 

17 
 
 
determine predictors of adherence and weight loss. Scores will be related to outcome measures 
and may be used as covariates in data analysis.   
▪ 
Behavioral questionnaires:  
▪ Gormally Binge Eating Scale (28): a self-report questionnaire to assess binge eating 
behavior. Subjects are asked to choose 1 response from a set of 4 possible choices in 
16 instances. This scale can successfully discriminate among persons having no, 
moderate or severe binge eating problems 
▪ The Questionnaire on Eating and Weight Patterns - Revised (QEWP-R) (29): a self-
report instrument used for diagnosis of binge eating disorder (BED), designed to 
describe both behavioral manifestations and feelings/cognitions surrounding a binge 
episode.   Volunteers will be excluded from the study if they have purging behaviors 
or have anorexia nervosa. 
▪  Perceived Stress Scale (PSS) (31): a 14-item self-reported questionnaire used to 
assess stress and an individual’s perceived ability to cope with such stress over the 
last 28 days 
▪ The Inventory for Depressive Symptomatology (IDS –SR)(32): a measure of 
depressive signs and symptoms, applicable to atypical depression which has been 
associated with overeating. Those who report suicidal ideation or have scores 
consistent with major depression will be referred for appropriate treatment and 
follow-up. The clinical research unit employs a licensed psychologist, but the 
Phoenix Indian Medical Center also has on-call behavioral health available 24 
hours/day 

18 
 
 
▪ Barratt Impulsivity Scale -11 (BIS-11) (33;34): a self-report scale which contains 30 
questions and has shown internal consistency across populations (34). There are 3 
subscales of the BIS, which categorizes impulsivity into 3 main aspects and has 3 
subscale scores: motor (acting without thinking), cognitive (quick decisions), and 
non-planning (present orientation) 
▪ Power of Food Scale (PFS: (35;36): is a 15-item self-report measure of individual 
differences in the appetitive drive to consume highly palatable food, independent of 
homeostatic hunger 
▪  The Social Problem-Solving Inventory - Revised (SPSI-R; (37): is a 52-item self-
report measure that uses a 5-point Likert scale to assess problem solving abilities. It 
has 5 subscales: 1) Positive Problem Orientation; 2) Negative Problem Orientation; 3) 
Rational Problem Solving; 4) Impulsivity/Carelessness Style; and 5) Avoidance Style 
▪ The NEO-FFI Neo-Five Factor Inventory (38): is a 60-question validated 
questionnaire to assess the five major dimensions of personality (Neuroticism, 
Extraversion, Openness, Agreeableness and Conscientiousness) 
▪ Weight Efficacy Lifestyle Scale (WEL; (39)): a 20-item questionnaire to rate 
confidence in ability to avoid eating on a 10-point Likert Scale 
▪ Treatment Self-Regulation Questionnaire (TSRQ; (40): to determine autonomous 
motivation (internal reasons for change) and controlled motivation (extrinsic reasons 
for change)  
▪ The Three-Factor Eating Questionnaire (TFEQ) (77): a 51-item questionnaire 
composed of 3 subscales. These subscales measure dietary restraint (i.e., the cognitive 
control of eating, 21 items), disinhibition (i.e., the tendency to have an uninhibited 

19 
 
 
response to food, 16 items), and perceived hunger (i.e., the susceptibility of eating in 
response to subjective feelings of hunger; 14 items) using “true/false” or multiple-
choice items.  
▪ Emotional Appetite Questionnaire (EMAQ) (78): used to examine eating response to 
both positive and negative emotions and situations.  
▪ The Childhood Trauma Questionnaire (CTQ; 120): is a 28-item self-report inventory 
that assesses abuse and neglect during childhood. 
▪ Physical Anhedonia Scale (PAS) (85): a 61-item scale to assess sensitivity to reward 
(STR). It is designed to reflect the degree to which individuals take pleasure from, 
and are motivated to engage in, rewarding behaviors. High scores on this scale reflect 
the anhedonic end of the STR dimension while low scores reflect ‘hedonia’ or the 
enhanced ability to seek out and enjoy natural rewards.  
▪ MacArthur Scale of Subjective Social Status (119): contains 2 ladders measuring 
subjective socio-economic status.  Studies have indicated that ladder rankings are 
more powerful determinants of health-related outcomes than traditional measures of 
SES (121).  
▪ U.S. Adult Food Security Survey Module: Six-Item Short Form: a 6-item self-report 
version of the original 18-item module for the assessment of food insecurity over the 
past 12-months. It classifies households into 3 categories of food security status 
according to the U.S. food security scale (120). It has been shown to identify food-
insecure households and very low food security with reasonably high specificity and 
sensitivity and minimal bias compared with the 18-item measure (122) and shows 
significant association between food insecurity and obesity. 

20 
 
 
▪ 
Psychological performance tests:  
▪ Iowa Gambling Task (41;42): to evaluate decision-making. Subjects will be 
instructed to try to gain as much fake money as possible by drawing 100 selections 
from a choice of 4 decks of cards, while starting with a loan. The decisions to choose 
from the decks should become motivated by reward and punishment schedules 
inherent in the task. Two of the decks are disadvantageous, producing immediate 
large rewards but these are (after a pre-punishment phase of about 10–15 cards) 
accompanied by significant money loss due to extreme punishments. The other 2 
decks are advantageous; reward is modest but more consistent and punishment is low. 
▪ Stroop Color Word Test (43): to assess selective attention. Words are presented on 
the screen in either a congruent (color screen with words printed in color) or 
incongruent set (color-word screen where the color and the word do not match [for 
example, the word “green” is printed in blue ink]). The subject has to either read the 
words or name the ink colors as quickly as possible within a time limit. A second 
Stroop task will be administered that will include food words that are printed in 
varying colors. Subjects will be asked to name the color rather than the name of the 
food. 
▪ Wisconsin Card Sorting Test (44): to examine cognitive executive functioning. 
Subjects are presented with 4 stimulus cards and 128 response cards. They are 
instructed to respond with response cards to match each of the 4 stimulus cards (based 
on either color, form or number, but directions are ambiguous), and are told if they 
are right or wrong. Once a certain number of correct answers are made, the sorting 

21 
 
 
principle is changed without warning, requiring the subject to figure out the new 
sorting strategy  
▪ Go/No Go Task (45): to examine inhibitory control. Subjects are required to press a 
key whenever a target stimulus is presented and to refrain from pressing the key when 
a non-target stimulus is presented   
• Meeting with study counselor: The counselor will review the weight-maintenance heart-
healthy dietary prescription and provide the volunteer with 3 days of food. The volunteer will be 
instructed to eat only the foods provided, consume no additional foods, maintain their current 
levels of physical activity, and to keep track on a self-monitoring food record form.   
• Weight Maintenance Dietary Prescriptions:   
▪ Recent studies have found that using free prepared meals facilitated greater adherence 
(16) and weight loss compared with a control group (17). Therefore, because the 
primary aim of our study is to compare differences between lean and obese groups 
and WMEN versus UF diets (rather than investigate real-world learning), all food 
items will be provided by the CRU, primarily as prepackaged meals and snacks for 
the volunteers to take home (see Table 2 for sample menu).  
▪ All diets will have 20%, 30%, and 50% of daily calories provided as protein, fat and 
carbohydrate, respectively. They are designated as "heart-healthy" because they will 
be balanced diets, which are also low in cholesterol and saturated fat.  
▪ During the baseline week, all participants will be fed their weight maintaining 
energy needs (WMEN), equal to the number of calories calculated for each 
participant based on the WHO equation with an activity factor (1.3-
1.5)(46;47), based on results from the PAR questionnaire.  

22 
 
 
▪ Women: 18 to 30 y: EE = 13.3 x weight (kg) + 344 x height (m) + 35 
 
            30 to 60 y: EE = 8.7 x weight (kg) - 25 x height (m) + 865  
▪ Men:    18 to 30 y: EE = 15.4 x weight (kg) - 27 x height (m) + 717 
30 to 60 y: EE = 11.3 x weight (kg) + 16 x height (m) + 901 
▪ During the first week, and prior to randomization, all patients will come for 2  
 
 
outpatient visits to be weighed  
▪ If their weight changes by 2%, their caloric intake will be adjusted by 200 kcal 
accordingly   
 
Baseline Visit 2: 
1. Weight 
2. Adjust calories by 2%, if needed 
 
Outpatient Visits (6 weeks):  
• Randomization: During the first outpatient study visit, participants will meet with a study 
counselor to discuss randomization assignment. They will be provided with 4 days of food 
and will again be instructed to eat only the foods provided, consume no additional foods, 
maintain their current levels of physical activity, and to keep track on a self-monitoring food 
record form.  Additionally, they will be instructed on how to use the smart-phone system 
o Heart-Healthy Dietary Prescriptions:   
▪ Both the lean and obese WMEN groups will continue to eat the same number 
of calories that were calculated for them during the baseline weight 
maintenance period 

23 
 
 
▪ The obese UF group will be assigned a diet of 35% of the calculated energy 
needs 
• Weight and BP:  obtained at each visit 
• Meal pick-up: meals will be prepared by the metabolic kitchen and picked up on a twice 
weekly basis 
• Meeting with Study Counselor:  Participants will meet 1x/week with a study counselor to 
review food records and dietary adherence.  The counselor will rate the participants adherence 
and participant will rate his/her adherence to the dietary prescription and to behavioral aspects on 
a 5- point Likert Scale (0 = low; 5 = high). Counselors will also obtain a rating of subjective 
hunger over the last week on the same Likert Scale (0 = low; 5 = high) and assess change in 
physical activity. Sessions will last 15-30 minutes. 
• Assessment of Adherence: Subjects will complete additional assessments of adherence: 
▪ 24-hour recall: this will be conducted by a member of the study staff other than the 
primary counselor to avoid bias  
▪ Computerized confessional: participants will complete a computerized battery of 
questions that will include a 24-hour recall with prompts to encourage recall of 
various foods possibly consumed at various times during the day. Questions about   
other weight and eating behaviors will be included. Data from this procedure will 
enable us to compare with the in-person interview version of the 24-h recall and 
assess reliability 
Outpatient Adherence Contacts: 
• 24-h recall by phone: a member of the study staff will call at a random time, 1x/week to 
conduct a 24-h food recall  

24 
 
 
• Ecological Momentary Assessment (EMA) using Smart-phones: participants will use Smart-
phones to monitor adherence. In brief, EMA research techniques reflect repeated, real-time 
(momentary) assessment in the participants' typical environment (48). Recent studies have 
shown that anger predicted binge episodes (Engel et al., 2007) and overall negative moods 
were higher on binge days than on non-binge days (Wegner et al., 2002).  Signal contingent 
recordings will be used, which involves respondents recording experiences whenever 
signaled at semi-random times throughout the day. Signals will occur two times/day: once 
between 8am and 3pm and once between 3pm and 9pm and will be randomly dispersed. 
When signaled, volunteers will be asked: 
▪ Since the last time you were signaled, have you eaten anything?  
▪ If yes, did you eat the study food provided to you? 
• If yes, did you finish the food? 
• If no, which foods didn't you eat?  
• Did you eat anything else (in addition to the food provided)?   
• If yes, what did you eat? 
• Mood will be assessed using the short version of the Positive and Negative Affect 
Scale (PANAS, Watson & Clark, 1989). Each item will be rated on a 7-point scale (0, 
none; 3 moderately; 6 extremely; Engel 2007; Wegner et al., 2002) 
• Phones will have a data service plan to allow for transfer of data from the phone to a 
stored network. GPS and/or other tracking systems will not be installed and 
volunteers will not be monitored or tracked via the smart phone. Participants will 
have the option of using their own smart phones if they already have one. 
 
 
 

25 
 
 
After completion of the 6-wk outpatient study, volunteers will repeat the following tests during 
their final outpatient visit:  
Post-Intervention Visit: 
• weight, blood pressure 
• Lab work; CBC, Research chemistry profile, urine HCG (for females) 
•    Repeat DXA  
• Repeat behavioral measures and psychological performance tests 
• Final adherence measurement and exit interview  
 
5. Patient monitoring: 
5.1 Criteria for individual subject withdrawal:  
Any subject experiencing (1) clinically apparent deterioration or severe side effects resulting 
from the dietary interventions or (2) who develops any medical problem that poses a safety risk 
for further participation will be withdrawn.  
 
6. Data Analysis and Sample Size:  
The design of this study will allow us to look at differences in levels of adherence to a heart-
healthy dietary prescription in lean vs. obese individuals. We will also be able to compare 
adherence levels in obese individuals who are being fed a WMEN diet compared to an UF diet. 
Additionally, we will measure predictors of adherence and the relationship between adherence 
and weight loss.  
 
Data Analysis:  

26 
 
 
Measuring Adherence: (see Appendix B): for all measures, adherence will be examined as a 
binary variable (adherent versus non-adherent). Each measure will be awarded 0 points if non-
adherent and 1 point if adherent.   
1. Attendance: two sessions per week: (adherent = attended; non-adherent = not attended; 
12 possible total points over the study). 
a. counseling  
b. food pick-up  
2. Food Diaries: volunteers will turn in diaries during their weekly counseling visit. For 
each weekly diary there will be three scores (18 possible total points over the study): 
a. Completion of records: adherent = completed diary; non-adherent = missing or 
incomplete diaries  
b. Dietary Adherence to Foods provided: adherent = consumed all; non-adherent = 
did not consume all  
c. Adherence to Additional Foods: adherent = did not consume any; non-adherent = 
consumed additional foods   
3. 24-hour recall in-person interview: once per week on day of counseling session.  For each 
session there will be three scores (18 possible total points over the study): 
a. Completion of interview: adherent = completed interview; non-adherent = did not 
complete interview    
b. Dietary Adherence to Foods provided: adherent = consumed all; non-adherent = 
did not consume all  
c. Adherence to Additional Foods: adherent = did not consume any; non-adherent = 
consumed additional foods   

27 
 
 
4. 24-hour recall using computerized confessional:  once per week on day of counseling 
session. For each session there will be three scores (18 possible total points over the 
study): 
a. Completion of records: adherent = completed interview; non-adherent = did not 
complete interview    
b. Dietary Adherence to Foods provided: adherent = consumed all; non-adherent = 
did not consume all  
c. Adherence to Additional Foods: adherent = did not consume any; non-adherent = 
consumed additional foods   
5. 24-hour recall (telephone): once per week. For each phone session there will be three 
scores (18 possible total points) 
a. Completion of recall: adherent = completed recall; non-adherent = did not 
complete recall    
b. Dietary Adherence to Foods provided: adherent = consumed all; non-adherent = 
did not consume all  
c. Adherence to Additional Foods: adherent = did not consume any; non-adherent = 
consumed additional foods   
6. EMA recordings: there will be two contacts per day. For each contact there will be three 
adherence scores. To avoid having EMA be more heavily weighted in the total score, the 
total weekly score will be divided by 7 to obtain an average weekly EMA score (42 
possible total points per week; 6 possible total average points): 

28 
 
 
a. Completion of recording: adherent = completed recording; non-adherent = did not 
complete recording. We will define incomplete or missing entries as non-adherent for 
that day.  
b. Dietary Adherence to Foods provided: adherent = consumed all; non-adherent = did 
not consume all  
c. Adherence to Additional Foods: adherent = did not consume any; non-adherent = 
consumed additional foods   
7. Additional Non-Intervention Related Adherence Measure (once per week. For each rating 
there will be 1 score (6 possible total points over the study): We will also track the arrival 
time for weekly counseling session as a measure of adherence that is not directly related 
to the study intervention.  Appointment adherence will be scored as the arrival within 5 
minutes of the scheduled time and actual arrival time will be documented as a continuous 
measure of adherence. This measurement will allow us to examine the relationship 
between adherence to the dietary protocol and adherence to "other" factors (e.g. 
punctuality) and it will be included in the total adherence score.   
a. Appointment adherence: adherent = arrived within 5 minutes of scheduled 
appointment; non-adherent = did not arrive within 5 minutes of scheduled 
appointment 
 
Adherence Score: The above variables will be totaled up to calculate a total adherence score out 
of a possible 21 points during each week. A percent (%) adherence score will also be calculated 
by dividing the total score by the number of variables assessed (21) and multiplying by 100 
([total/21]*100).   

29 
 
 
 
 
Statistical Analysis: 
 
For our primary hypothesis, a one-way ANOVA will be performed with total adherence 
score as the dependent variable and group status (lean WMEN, obese WMEN, obese UF) as the 
independent variable.  In addition, linear regression models adjusted for covariates including age, 
sex, race, socioeconomic status (SES) and baseline weight or percent body fat will also be used 
to examine the relationship of adherence and behavioral factors.  Correlations between adherence 
scores, behavioral test scores and weight, fat mass and fat free mass loss will be calculated. 
Pearson’s r will be calculated for data that are normally distributed and Spearman’s correlation 
will be used if the distributions are non-normal. This will be an intention to treat study such that 
everyone who completes the run-in phase will be included in the final analysis. Missing data will 
be completed using a multiple imputation method utilizing the SAS procedures, PROC MI and 
MIANALYZE. This method introduces variability into the imputed values to reduce the risk of a 
type 1 error. All tests will have a 2-sided Type I error of p = 0.05. 
 Power Calculation: 
Sample size calculations are based on the number of individuals needed to demonstrate a 
significant difference in adherence scores over the 6-week intervention period between the 3 diet 
groups (lean WMEN, obese WMEN, obese UF).  
We based our expected percent adherence score on a recent paper by Williamson et al 
(26) who observed 52% adherence in a group of obese dieters.  Our maximum possible 
adherence score is 21 per week. To account for the increased adherence we expect to see because 
food is being provided in the study, we have increased the proposed adherence from the 52% 

30 
 
 
adherence observed in the POUNDS LOST study by an additional 10% and applied this increase 
in score across all 3 groups. Thus, assuming 62% adherence, we would expect a mean weekly 
score of 13 in the calorie restricted group.  If we in addition, consider a smaller a meaningful 
difference between the groups of 3 points; (lean WMEN = 19, obese WMEN = 16, obese UF = 
13), assuming the same  SD = 6, with a calculated sum of squares of the means = 32, across 3 
treatment groups with a mean 16 +/- SD = 6, alpha = 0.05, the proposed total of 20 subjects per 
group (total n = 60) would allow us to achieve a power of 0.793 (see table 3a).  If we assume a 
larger difference between the groups 3.5 points; lean WMEN = 20, obese WMEN = 16.5, obese 
UF = 13), the proposed total of 20 subjects per group (total n = 60) would allow us to achieve a 
power of 0.906 (see Table 3a).  Because the drop-out rate in weight loss intervention studies 
averages around 25%, we plan to recruit a total of 150 subjects (25 per group) to account for 
both screening failures and attrition, and to ensure 60 completers (see Table 3b). 
 
7. Benefits: 
This is a supervised dietary outpatient study being offered to lean and overweight/obese 
individuals.  The prescribed diet is "Heart-healthy" and could improve metabolic and health 
outcomes in all 3 groups.  In addition, those in the UF group who adhere to the diet may 
experience weight loss, which may lead to additional favorable future metabolic outcomes. All 
volunteers will receive information regarding some aspects of their health, including lab 
screening tests, a thorough physical examination, a measure of body fat, and an evaluation of 
their glucose tolerance status.  The results of these tests will be available to the subjects and will 
be provided to their personal physician, if desired. Other expected benefits of this study include 
obtaining generalizable knowledge related to the difference in levels of adherence between lean 

31 
 
 
and overweight/obese individuals, which has not yet been examined.  We will also gain 
knowledge about predictors of treatment adherence for weight loss and the relationship between 
adherence and weight loss.  Moreover, we are proposing novel ways to measure adherence, 
which could be used in future studies.  The information obtained from this study should be useful 
to scientists, physicians, and psychologists.  
 
8. Human Subjects Precautions: 
8.1. Recruitment and Minority Participation 
Participants will be recruited via advertising in local newspapers and on the internet, strategies 
which have proved successful in the past. Based on our previous studies, we expect the ethnic 
diversity of our volunteers to be approximately 40% Caucasian, 40% Native American, 10% Black 
and 10% Hispanic. Native Americans represent approximately 2% of the population in greater 
Phoenix area, and we anticipate over-representation because our unit is situated within the Phoenix 
Indian Medical Center. Additionally, Native Americans have previously participated in many of our 
studies. We anticipate recruiting approximately 5 volunteers per month (60/year) over the course of 
about 1.5 years.  
8.2. Safeguards for subjects: 
Subjects will have the option of discontinuing the study at any time.  All data will be treated 
confidentially, and the identity of subjects will not be disclosed in publications. Participants will 
be monitored (weight and blood pressure) and seen by a counselor weekly. Any participant 
judged on clinical grounds to have suffered any adverse effect will be evaluated by a provider 
(physician, physician assistant, nurse practitioner, or psychologist). 
8.3. Risks and Discomforts: 

32 
 
 
8.3.a Radiation exposure due to DXA: The DXA scans will take place on  the GE Lunar iDXA 
machine. The radiation exposure for a 188 mA scan may be as much as 1 mrem as indicated by a 
January 2014 internal radiation exposure review. According to the manufacturer, the medium 
and fast slow scan speeds are likely to result in one-half the radiation exposure of the slow scan 
speed. A typical radiation dosage from this procedure is equivalent to 1.22 days (iDXA)  of 
exposure to natural background sources, such as the sun and outer space, or radioactive materials 
found naturally within the earth’s air and soil. For subjects who move excessively during the 
scans, a complete or partial repeat of the scan procedure may be necessary. Thus, subjects could 
receive a maximum of 2 mrem (iDXA, 2.5 days of exposure) if the slow scanning mode is used 
each time. Participants in this study will undergo 2 DXA scans over the study period therefore 
the maximum amount of radiation they will receive in the first year could be as high as 4 mrem 
(iDXA, 5 days of exposure). This exposure increases the percent cancer risk from 25 percent to 
25.00016 (iDXA). This is well within the NIH Phoenix Radiation Safety Guidelines for research 
subjects of 3,000 mrem in a 13-week period and 5,000 mrem per year. A urine pregnancy test 
will be performed in all females who are able to become pregnant prior to each DXA scan.  
8.3.e  Dietary Intervention:  The side-effects of consuming a pre-selected diet are minimal and 
might include boredom, lack of desire to eat the prescribed foods and/or increased feelings of 
hunger.  
8.3.e  Questionnaires and computer performance tests: There are no known risks associated with 
completing any of these questionnaires. However, some of the questions may be of a highly 
personal nature; thus, subjects will be informed that they do not have to respond to all the 
questions if they choose not to do so. If this is the case, notations to that effect will be noted in 
the patient’s record. 

33 
 
 
8.3.f  Urine Drug Screen: Results of this test will be used only to determine study eligibility.  If 
the result is positive, patients will be confidentially informed of the results and a 
recommendation for follow-up will be made with their primary physician. 
8.3.g  Blood Withdrawal: The amount of blood that may be drawn from adult patients and 
volunteers (i.e., those persons 18 years of age or older) for research purposes shall not exceed 
10.5 mL/kg or 550 mL, whichever is smaller, over any eight week period.  
8.3.h  Adherence Measurements: Receiving phone calls from study staff and completing EMA 
assessments and food records could be perceived as a nuisance, but there are no known risks.  
Recalling food eaten, associated moods and related activities could induce negative emotions but 
the risks are minimal.   
8.4. Disclosure of medical conditions: 
The participants will be informed of any medical conditions uncovered by the screening blood 
work performed and referred to their primary care provider. The information will also be entered 
into their medical records and, at the patient’s request, sent to their physicians. In the event that 
during screening, participants are found to have psychotic symptoms and present a danger to 
themselves or others, behavioral health services (available on site in the facility) will be 
contacted for appropriate referrals. All information from the study will be made available to the 
patients and their physicians at the patients’ request. Information will be treated with the same 
protection and confidentiality as all other medical records. All information from the study may 
be made available to insurance companies if the information is requested by the insurance 
company and the subject signs a release of information. This could affect future insurability and 
employment opportunities. 
8.5. Data and Safety Monitoring:  

34 
 
 
8.5. a. Independent Data Safety Monitoring Board: Potential adverse events from this study are 
expected to be infrequent. Therefore, the principal investigator (PI) will act as the safety monitor 
and report these events to the NIDDK IRB.  Study procedures will be subject to audits and/or 
monitoring visits to ensure compliance with the protocol and applicable regulatory requirements 
consistent with the PIMC quality assurance program plan.  Audit and/or monitoring visits results 
will be reported to the Principal Investigator for further reporting as appropriate.  Study 
documents and pertinent hospital or clinical records will be reviewed to verify that the conduct 
of the study is consistent with the protocol plan.8.5.b. Adverse events, protocol deviations, 
unanticipated problems (UP), serious adverse events, are defined as described in NIH HRPP 
SOP 16 (“Reporting Requirements for Unanticipated Problems, Adverse Events and Protocol 
Deviations”). All adverse events occurring during the study, including those observed by or 
reported to the research team, will be recorded and assessed for relatedness to the study 
procedures or treatments, severity and whether or not they are expected (in nature, severity and 
frequency). Serious unanticipated problems and serious protocol deviations will be reported to 
the IRB and Clinical Director (CD) as soon as possible but not more than 7 days after the PI first 
learns of the event. Non-serious unanticipated problems will be reported to the IRB and CD as 
soon as possible but not more than 14 days after the PI first learns of the event. Non-serious 
protocol deviations will be reported to the IRB as soon as possible but not more than 14 days 
after the PI first learns of the event. Non-serious protocol deviations that result from the normal 
subject scheduling variations or technical issues associated with sampling that does not impact 
the health of the subject or the interpretation of the study data will not be reported.  Deaths will 
be reported to the CD and the IRB within 7 days after the PI first learns of the event. Previously 
undiagnosed medical conditions discovered by laboratory testing or imaging will not be reported 

35 
 
 
as adverse events, but will receive appropriate follow-up and referral to the primary care 
provider. 
• The PI is responsible for summarizing all adverse events at least possibly related to the 
research procedure and interventions at the time of Continuing Review. All deaths that 
have occurred among study participants since the previous review will be summarized at 
the time of continuing review. 
8.6. Research Use of Stored Human Samples, Specimens or Data: 
 
Blood (stored as plasma or serum) and urine samples not immediately used for study 
purposes will be stored for future measurements. Remaining plasma, serum, and urine samples 
will be stored in freezers located on the premises at the NIH in Phoenix. Stored samples and 
specimens will be used only to measure factors which relate to obesity and its complications and 
weight loss interventions. Stored samples, specimens or data may be sent to collaborators for 
specific measurements or analyses. All stored samples, specimens, and data will be coded so that 
when sent for measurements the identity of the volunteer remains confidential. Identification of 
coded samples will be kept in a secure, password-protected database accessible only to 
investigators, but will be identifiable in case specific tests yield clinical information of 
importance to a particular volunteer or samples can be destroyed per volunteer request (see 
below). Samples will be used only for research and not for commercial purposes. Research 
volunteers will not be informed of individual results from analyses performed specifically for 
research purposes; unless there is clear evidence accepted by the medical community that these 
results will impact the volunteer’s individual medical care or future health. Samples will be 
stored until used and will not be destroyed unless specifically requested in writing by the 

36 
 
 
volunteer. Reports of samples lost due to technical issues or destroyed secondary to volunteer 
request will be included in the annual renewal report. 
 
At this time, there is a consultative relationship set up with Drs. Scott Engel and Ross 
Crosby of the Neuropsychiatric Research Institute in Fargo, North Dakota. Drs .Engel and 
Crosby will assist with implementing the Smartphone EMA protocol and will aid in analysis of 
the data.  The data will be uploaded to a server that will be accessible to Dr. Gluck and her team, 
as well as to Drs. Engel and Crosby.  Additionally, they will receive related study data, including 
adherence scores and other metabolic parameters collected during the study for assistance with 
the data analysis and interpretation of the results.  
 
8.7. Reimbursement:  Reimbursement will be offered to study participants who will get paid for 
their visit to the clinical research ward as follows, per local Ethics Committee guidelines: 
Volunteers will be compensated $25 for the screening visit. Total reimbursement for the 7 week 
study will be at a flat rate of $625.00.  A payout of $50.00 will be given at the end of the 3rd 
study week with the balance of $575.00 at completion of the study with return of the smart 
phone. If the smart phone is not returned for any reason, the balance of the payment will not be 
paid at the end of the study.* 
 
 ** If discontinuation occurs prior to completion of the study (7 weeks), reimbursement 
will be at the rate of $10.00 per visit, beginning with the first outpatient visit. This 
reimbursement rate goes into effect if the study is not completed for any reason, i.e. occurrence 
of illness, family emergency, or per investigator discretion in the event of noncompliance with 
study procedures.    
  
 Screening Visit: 
Screening payment @ $25.00/d   
$25.00 
Baseline Visits 

37 
 
 
Baseline Assessment visit (@35$) 
$35.00 
3 inconvenience units for psychological assessments 
(baseline visit) 
$75.00 
Daily payment (@$35) for outpatient visit x 2: weight 
maintaining period 
$70.00 
Total 
$185.00 
Outpatient Visits: 
Daily payment (@$35) for outpatient visit x 6 (counseling 
sessions) 
$210.00 
Travel compensation (@10$) for outpatient visit x 6 (food 
pick-up) 
$60.00 
3 inconvenience units for repeat psychological assessments 
during final visit 
$75.00 
Bonus for study completion  
$100.00 
Total 
$445.00 
 
 
Total Reimbursement (including screening visit):  $ 650.00   
 
 
TABLE 1:  STUDY PROCEDURES 
 
 
                        Baseline & Wt. Maintenance Visits             Outpatient Study Visits 
PROCEDURES 
SV 1 
BV1 
BV2 
WK 1  
WK 2   WK 3   WK 4  
WK 5 
 WK 6 
Screening lab tests  
X 
 
 
 
 
 
 
 
X 
DXA 
 
X 
 
 
 
 
 
  
X 
Psychological assessments  
  
 X 
 
 
 
 
 
 
X 
Randomization & instructions 
 
 
 
X 
 
 
 
 
 
Clinic Visit/ Food Pick-up 
 
X 
X 
XX 
XX 
XX 
XX 
XX 
X 
Weight and BP 
X 
X 
X  
XX 
XX 
XX 
XX 
XX 
XX 
Meet w/counselor 
 
X 
  
X 
X 
X 
X 
X 
X 
24-h recall interview 
 
 
 
X 
X 
X 
X 
X 
X 
Complete computerized recall 
 
  
 
X 
X 
X 
X 
X 
X 
EMA assessments 
 
 
 
XXXX
XXXX
XXXX
XXXX
XXXX
XXXX
XXXX
XXXX
XXXX
XXXX
XXXX
XXXX

38 
 
 
XXXX
XX 
XXXX
XX 
XXXX
XX  
XXXX
XX 
XXXX
XX 
XXXX
XX  
24-h food recall by phone 
 
  
 
X  
X  
X  
X  
X 
X 
 
 
 
 

39 
 
 
TABLE 2:  Sample Menu 
 
Item Name
QuantityMeasure Cals(kcal)Prot(g) Carb(g)Fat-T(g)
Day 1 (1/3/2012)
2002
90
299
55
Breakfast
338
17
64
3
Instant Breakfast, chocolate, pkt
1 Each
131
7
24
1
Banana, fresh, med, 7" to 7 7/8" long
1 Each
105
1
27
0
Milk, 1%, w/add vit A & D
1 Cup
102
8
12
2
Lunch
651
26
103
16
Lean Cuisine, Grilled Chicken & Penne
1 Each
385
23
61
5
Carrots, baby, fresh
3 Ounce-Wt
40
1
9
0
Apples, fresh, sliced
6 Ounce-wt
88
0
23
0
Heat & Serve Roll
1 Serving
53
2
10
1
Spread, buttery, Omega Plus
1 Tablespoon
85
0
0
9
Dinner
622
28
82
21
Dinner, chili & cornbread, ckd f/fzn
1 Each
560
27
67
21
Oranges, fresh, med, 2 5/8 " diameter
1 Each
62
1
15
0
Evening Snack
391
18
51
14
Formula, choc, rtu
1 Serving
250
9
40
6
Cheese, mozzarella, string, part skim
1 Each
80
8
1
6
crackers, original, Triscuit
0.5 Ounce-wt
61
2
10
2
 
 
 
 

40 
 
 
TABLE 3A & 3B:  POWER CALCULATION 
 
3A 
The SAS System                        09:21 Thursday, July 12, 2012   9 
 
                                                      The POWER Procedure 
                                               Overall F Test for One-Way ANOVA 
 
                                                   Fixed Scenario Elements 
 
                                              Method                       Exact 
                                              Alpha                         0.05 
                                              Group Means               13 16 19 
                                              Standard Deviation               6 
 
 
                                                        Computed Power 
 
                                                              N Per 
                                                     Index    Group    Power 
 
                                                         1       10    0.458 
                                                         2       12    0.543 
                                                         3       14    0.619 
                                                         4       16    0.686 
                                                         5       18    0.744 
                                                         6       20    0.793 
                                                         7       22    0.834 
                                                         8       24    0.868 
                                                         9       26    0.896 
                                                        10       28    0.918 
                                                        11       30    0.936 
 
 

41 
 
 
   3B 
                                                     The SAS System                        09:21 Thursday, July 12, 2012  10 
 
                                                      The POWER Procedure 
                                               Overall F Test for One-Way ANOVA 
 
                                                   Fixed Scenario Elements 
 
                                              Method                       Exact 
                                              Alpha                         0.05 
                                              Group Means             13 16.5 20 
                                              Standard Deviation               6 
 
 
                                                        Computed Power 
 
                                                              N Per 
                                                     Index    Group    Power 
 
                                                         1       10    0.590 
                                                         2       12    0.685 
                                                         3       14    0.762 
                                                         4       16    0.823 
                                                         5       18    0.870 
                                                         6       20    0.906 
                                                         7       22    0.933 
                                                         8       24    0.952 
                                                         9       26    0.967 
                                                        10       28    0.977 
                                                        11       30    0.984 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

42 
 
 
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46 
 
 
 SCORE SHEET 
Week1 
 (0 no, 1 yes) 
Week 
2 
Week 
3 
Week 
4 
Week 
5 
Week 6 
Session #1 Attendance (weight, counseling, 
24-h interview, computer confessional, food 
pick-up) 
1   
  
  
  
  
▪   Food Diaries completed 
0   
  
  
  
  
▪   Food Diary food supplied 
0   
  
  
  
  
▪ Food diary consuming other food 
0   
  
  
  
  
▪ 24-hr recall interview completed 
1   
  
  
  
  
▪ 24-hr recall interview food supplied 
1   
  
  
  
  
▪ 24-h recall interview consuming other 
foods 
0   
  
  
  
  
▪ Computer confessional completed 
1   
  
  
  
  
▪ Computer confessional food supplied 
1   
  
  
  
  
▪   Computer confessional consuming other 
food 
0   
  
  
  
  
Session Attendance (#2: wt, food pick-up) 
1   
  
  
  
  
24-hr recall phone completion (1) 
1   
  
  
  
  
24-hr recall phone food supplied (1) 
1   
  
  
  
  
24-h recall phone consuming other foods (1) 
0   
  
  
  
  
EMA daily completion of records (1) 
7   
  
  
  
  
EMA daily adherence of foods supplied (1) 
6   
  
  
  
  
EMA daily adherence of consuming other 
foods (1) 
4   
  
  
  
  
EMA daily completion of records (2) 
5   
  
  
  
  
EMA daily adherence of foods supplied  (2) 
5   
  
  
  
  
EMA daily adherence of consuming other 
foods (2) 
2   
  
  
  
  
AVERAGE weekly EMA Score (total possible 
= 6) 
4.1   
  
  
  
  
On Time Arrival for Session 
1 
 
 
 
  
Total Score 
13.1   
  
  
  
  
% Adherence (total/21) *100 
62%