A Novel Telehealth Intervention Using Nutrition and Exercise to Extend Intervention Benefits: Enhancing Physical Function in the Long-term for Obese Older Adults
Phase: NA
Conditions: Weight Loss Maintenance
Sponsor: Duke University

 
 
 
 
 
 
 
A Novel Telehealth Intervention using Nutrition and Exercise to Extend Intervention Benefits: 
Enhancing Physical Function in the Long-term for Obese Older Adults 
Pro 00105630 
Version 1.0 
4/24/2020 
NCT04490356 
 

 
Regulatory Sponsor: 
Dr. Janet Prvu Bettger 
Duke University 
Department of Orthopaedic Surgery 
DUMC 2919, 40 Duke Medicine Circle 
Dept of Orthopaedic Surgery, Room 5339 
Durham, NC 27710 
919 613 0379 
Funding Sponsor: 
National Institutes of Health (NIH) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Summary 
Title 
A Novel Telehealth Intervention using Nutrition and Exercise to Extend 
Intervention Benefits: Enhancing Physical Function in the Long-term for 
Obese Older Adults 
Short Title 
Enhancing Physical Function in the Long-term for Obese Older Adults 
Protocol Number 
Pro00105630 
Phase 
N/A 
Methodology 
Qualitative individual interviews and/or focus groups will be conducted 
in-person or via the phone with: obese older adults who previously 
(within the last 20 months) participated in a weight loss intervention  
Single-arm pilot intervention investigating the feasibility, fidelity, and 
acceptability of a tele-nutrition and tele-exercise 3 month weight 
maintenance intervention 
Study Duration 
1 year 
Study Center(s) 
Single-center  
Objectives 
This study seeks to develop and test the feasibility, acceptability, and 
fidelity of a tele-nutrition and tele-physical activity weight-
maintenance intervention tailored towards obese older adults who 
recently lost weight.  
Number of Subjects 
Up to 60 (Aim 1: up to 30; Aim 2: up to 20) 
Diagnosis and Main 
Inclusion Criteria 
Past participants of  weight loss intervention for obese, older adults  
Study Product, Dose, 
Route, Regimen 
N/A 
Duration of 
administration 
N/A 
Reference therapy 
N/A 
Statistical 
Methodology 
We plan to use applied thematic analysis for the semi-structured 
interviews and focus groups. Descriptive statistics, proportions for 
feasibility, adherence and retention will be calculated, and student’s t-
test will be conducted to compare weight change over time in the pilot 
study.  
 

1 Introduction 
This document is a protocol for a human research study. This study is to be conducted 
according to US and international standards of Good Clinical Practice (FDA Title 21 part 312 and 
International Conference on Harmonization guidelines), applicable government regulations and 
Institutional research policies and procedures.  
1.1 Background 
The obesity pandemic, in combination with population aging, has created an urgent demand for 
effective treatments for geriatric obesity. Almost 40% of older ( >60 years) adults in the U.S. are 
obese (BMI >30 kg/m2) (1) and similar trends are being recorded globally (2). Older adults with 
excessive body weights experience dramatic losses of mobility, independence, and 
performance of activities of daily living, as well as a host of metabolic and quality of life 
concerns (3-5). Yet, just as with other adult cohorts, obesity reduction presents a formidable 
challenge for older adults.  In addition to their lower calorie requirements (due to decreased 
metabolic rate) and more sedentary lifestyles, older adults are prone to sarcopenia (loss of 
muscle mass and strength), which may be exacerbated by weight reduction. It is because of this 
concern that the advisability of obesity reduction in older adults has been called into question 
(6).  However, there is increasing evidence that short-term weight loss can be safely achieved in 
this population (7), including our recent work showing improved function with enhanced 
protein intake during weight reduction (8).  
The next step in evaluating the advisability of geriatric obesity treatment is to determine 
whether such benefits achieved during a period of relatively intense obesity treatment are 
retained over time, a so called “legacy effect”. A legacy effect has happened when the benefits 
from a treatment or intervention are shown to persist when the intervention is no longer being 
administered (put both references here instead of after next sentence). “Metabolic memory,” a 
related term, has been used to describe the long-term impact of intensive diabetes treatment 
(9, 10). The potential that a short-term treatment could yield long-term benefits could be 
especially promising for obese older adults, who often face a number of obesity-related 
comorbidities and may not be able to sustain the extra burden of an ongoing weight control 
regimen. Unfortunately, only two studies, to our knowledge, have explored the legacy effect of 
obesity reduction in older adults (11, 12), and only the study by Waters et al. (12) reported 
physical function outcomes. These investigators conducted an 18-month follow-up assessment 
in 16 frail, obese older subjects who had participated in a one year, single-armed weight loss 
plus exercise trial; they confirmed maintenance of benefits to body weight, physical function, 
insulin sensitivity, and other metabolic markers. Chmelo et al. (13), conducted an 18-month 
follow-up to a 5-month trial of resistance training (RT) versus resistance training plus caloric 
restriction (RT +CR), assessing body weight and composition as well as thigh composition but 
not physical function. They reported loss of thigh muscle mass in both groups and found weight 
regain and increased total fat mass in the RT +CR group.  
While obesity interventions have been shown to provide dramatic functional benefits, the 
sustainability of these results over time and the net long-term impact on function is unknown. 

Very recently (Figures 1 and 2 below; manuscript in 
preparation), we have shown a “legacy effect” of 
obesity treatment in this population; finding that the 
functional benefits of an intense period of 
intervention persist for a year or more, even if there 
has been weight regain. Given this exciting finding, 
we hypothesize that a practical, sustainable 
telehealth intervention can be developed and 
implemented to magnify and extend these important 
legacy benefits. In the proposed research, we will 1) 
utilize experiences from the target population and 
experts in the field to develop a program of novel 
telehealth technologies to maintain and extend the 
legacy benefits of obesity treatment, and 2) evaluate 
the feasibility of this treatment in a pilot study of 
obese, functionally frail older adults.  
 
 
2 Study Objectives 
 
AIM 1a: In a series of semi-structured interviews with obese, functionally frail older adults 
who recently completed an intensive obesity intervention, we will collect key qualitative 
information on determinants (facilitators and barriers) of success in maintaining the 
functional benefits of obesity treatment over time. In ≥24 past weight loss intervention study 
completers (within 6 to 24months), we will conduct semi-structured interviews with 1) past 
participants who have maintained their weight loss and functional improvements, to identify 
personal beliefs, behaviors, and environmental factors that facilitated their success, and 2) past 
participants who have regained their weight, to identify personal beliefs, behaviors, and 
environmental factors leading to their treatment relapse. 
 
AIM 1b: Utilizing results of Aim 1a, along with elements of our previously established 
evidence-based obesity intervention, we will develop a tele-nutrition and tele-exercise 
program intended to maintain and extend the benefits of a recent obesity intervention. 
Utilizing the information obtained from the semi-structured interviews and in consultation with 
experts in the area of telehealth, we will create a novel program of tele-nutrition and tele-
exercise guided by the Social Cognitive Theory.3 The goal will be to maintain and extend the 
functional and quality of life benefits achieved in an intensive obesity intervention for older 
adults.   
 
AIM 2: We will conduct a 3-month program of tele-nutrition and tele-exercise in 10 obese, 
functionally frail older adults who have successfully completed an obesity intervention (lost 
5% of their body weight and increased SPPB by 1 point) and determine its feasibility, 
acceptability, and fidelity. Specifically, we will evaluate the feasibility (recruitment/retention) 

of an intervention designed to extend legacy benefits, its acceptability (as assessed by attrition 
and participant satisfaction), and its fidelity (as assessed by adherence). Additionally, we will 
access physical function (SPPB) at 0 and 3 months.  
 
3 Study Design 
3.1 
General Design 
We have used the NIH Stage Model to illustrate our past, present and future vision for an 
implementable and effective intervention that preserves the benefits of obesity treatment in 
overweight and obese older adult populations. As illustrated in Figure 3, we will build upon our 
previous research findings and engage participants who have or have not successfully 
maintained their function and weight loss to identify determinants of success/failure and 
develop a patient-centered tele-nutrition and tele-exercise program (“Legacy Intervention”) 
 (Stage 0). Feasibility and acceptability of the “Legacy Intervention” will be tested among obese, 
older adults who have successfully completed an intensive obesity intervention (Stages 
1a/1b). Qualitative feedback via semi-structured interviews (Aim 1a) and focus group (Aim 2) 
will be utilized throughout this project to allow for refinement and modification to maximize 
implementation. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2 Primary Study Endpoints 
Individual interview group feedback (transcripts) to identify personal beliefs, behaviors, and 
environmental factors that facilitated their success or treatment relapse.  
Determine the feasibility, acceptability, fidelity of a tele-nutrition and tele-physical intervention.  
 
 
 
 

4 Subject Selection and Withdrawal 
 
 
4.1 Inclusion and Exclusion Criteria 
From Aim 1a and Aim 2: All potential participants will have previously participated in a weight 
loss intervention conducted by the Bales Starr Nutrition Lab and checked the box on their 
consent form that states, "Yes, I agree to be contacted about potential future follow-up and 
future research studies.”  
 
Study staff will contact potential subjects to request their participation in the study. If potential 
subjects express interest, they will go through a phone screening process to determine initial 
eligibility. If potential subjects pass the screening process, they will be sent a consent form 
through REDcap and a virtual consent appointment will be scheduled.  
 
Aim 1a:  
We will contact our past participants, who previously agreed to be contacted for future 
research study, and successfully completed a lifestyle intervention (lost at least 3% body weight 
and increased short physical performance battery (SPPB) score by 1 point or 6-minute walk test 
(6MWT) by 50 meters) within the last 6 to 24 months. Inclusion/Exclusion criteria is below:  
Table 1. Inclusion/Exclusion Criteria Aim 1a  
Inclusion Criteria 
Exclusion Criteria  
• 
Participated in a weight loss 
intervention in the last 6 to 18 
months and lost ≥ 3% body 
weight and improved SPPB 
score by ≥ 1 point or 6MWT by 
≥ 50 metes (Perera et al. J Am 
Geriatr Soc. 2006;54(5):743-9) 
• 
Age ≥ 60 
• 
Able to speak and understand 
spoken and written English. 
• 
Presence of unstable or symptomatic life-
threatening illness 
• 
Neurological conditions causing functional 
impairment, including Parkinson’s disease, 
multiple sclerosis, and permanent disability due 
to stroke 
• 
Inability to complete physical function 
assessment  
• 
Unwilling to have their individual interview audio 
recorded  
• 
History of cognitive impairment  
 
 
Aim 2: Participants who agreed to be contacted for future research studies will be recruited 
from our on-going weight loss interventions and inclusion and exclusion criteria is below:  
Table 3. Inclusion/Exclusion Criteria Aim 2  
Inclusion Criteria 
Exclusion Criteria  

• 
Participated in a weight loss 
intervention in the last 3 
months and lost ≥ 3% body 
weight and improved SPPB 
score by ≥ 1 point or 6MWT by 
≥ 50 metes (Perera et al. J Am 
Geriatr Soc. 2006;54(5):743-9) 
• 
Age ≥ 60 
• 
Able to speak and understand 
spoken and written English. 
• 
Able to record dietary intake 
and weight 
• 
Presence of unstable or symptomatic life-
threatening illness 
• 
Neurological conditions causing functional 
impairment, including Parkinson’s disease, 
multiple sclerosis, and permanent disability due 
to stroke 
• 
Inability to complete physical function 
assessment  
• 
No access to internet connection to participate 
in the tele-intervention  
• 
Unable or unwilling to use provided tablet to 
participant in tele-intervention 
• 
History of cognitive impairment   
 
 
4.2 Subject Recruitment and Screening 
1. All potential participants will have successfully participated and completed (lost at least 
3% body weight and improved function (SBBP score by 1 point or 6MWT by 50 meters) a 
weight loss intervention conducted by the Bales Starr Nutrition Lab and checked the box 
on their consent form that states, "Yes, I agree to be contacted about potential future 
follow-up and future research studies.” For Aim 1a, participants will have successfully 
completed a weight loss intervention in the past 6 to 18 months. For Aim 2, potential 
participants will have successfully completed a weight loss intervention in the past 3 
months. Participants in Aim 1a will be completely different from participants in Aim 2. 
2. Potential participants identified will be contacted by study to determine interest. If 
participants are interested a telephone screen will be conducted to determine eligibility. 
 
4.3 Early Withdrawal of Subjects 
4.3.1 When and How to Withdraw Subjects 
Participants may be withdrawn from the study if they are disruptive during the group 
discussions or cannot be contacted by the study staff after initial contact. 
5 Study Procedures 
AIM 1a: Collect key qualitative data on determinants (facilitators and barriers) of success in 
maintaining the functional benefits of obesity treatment over time.  

Interview Participants: The Bales Starr Nutrition Lab at Duke University currently have two 
ongoing weight loss interventions in obese, older adults. We will contact our past participants, 
who previously agreed to be contacted for future research study, and successfully completed a 
lifestyle intervention (lost at least 3% body weight and increased short physical performance 
battery (SPPB) score by 1 point or 6-minute walk test (6MWT) by 50 meters) within the last 6 to 
18 months. Participants who pass the telephone screen are willing to participate will be 
consented (Tabe 1), weighed, and complete the SPPB and 6MWT to determine their current 
functional status. Participants will then be separated into one of two 
groups, Maintainers or Non-maintainers, based on their current functional status (Table 2; 
n=12 to 15 per group or until thematic saturation is reached in each group). Next, semi-
structured interviews will be conducted to identify personal beliefs, behaviors, and 
environmental factors that facilitated their success or treatment relapse.  
Table 1. Inclusion/Exclusion Criteria Aim 1a  
Inclusion Criteria 
Exclusion Criteria  
• 
Participated in a weight loss 
intervention in the last 6 to 18 
months and lost ≥ 3% body 
weight and improved SPPB 
score by ≥ 1 point or 6MWT by 
≥ 50 meters (Perera et al. J Am 
Geriatr Soc. 2006;54(5):743-9) 
• 
Age ≥ 60 
• 
Able to speak and understand 
spoken and written English. 
• 
Presence of unstable or symptomatic life-
threatening illness 
• 
Neurological conditions causing functional 
impairment, including Parkinson’s disease, 
multiple sclerosis, and permanent disability due 
to stroke 
• 
Inability to complete physical function 
assessment  
• 
Unwilling to have their individual interview audio 
recorded  
• 
History of cognitive impairment 
 
Setting: Screening will be conducted by telephone. Consents will be sent electronically and a 
consent presentation will be conducted virtually using Duke Zoom. Consented participants will 
come to the Duke Center for Living Stedman Center and will complete SPPB and 6-minute walk 
to determine their group assignment based on functional outcomes (Table 2). Next, using 
telephone or Duke Zoom, participants will undergo a guided semi-structured interview (sample 
interview guide for both groups below).   
 
Table 2. Aim 1a Participants  
Groups 
Criteria  
Social Cognitive Theory  
Maintainers  Physical function improvements were 
maintained 
Personal, environmental, and behavioral 
facilitators  
Non-
maintainers  
Physical function improvements were 
regressed  
Personal, environmental, and behavioral 
barriers  
 
 

Note to IRB:  This is an interview guide for semi-structured qualitative interviews of participants 
as laid out in the study protocol.  The interviewer will use this guide to organize the interview.  
Because it is a guide, exact questions may vary during the course of the interview or order may 
vary somewhat depending on answers given by participants.  However, the guide provides a 
general structure and order for questions and ensures that all domains are covered in the 
interview as appropriate, based on the answers of the participant being interviewed. The 
interviewer will adhere to the guide, but will also follow the conversation, which may stray 
from the guide as he/she feels is appropriate. 
Sample semi-structured interview guide for the Maintainers 
1. Personal 
1. Do you see yourself differently than you did before or during the study? 
2. How does it feel to have maintained your weight loss/function status? 
3. What is your definition of success, as it relates to your weight or health? 
4. What’s one thing that is contributing to your success of maintaining weight 
loss/continuing to eat healthy? 
5. When you think of other goals you have achieved, what about you do you 
believe helped you to achieve them? 
1. Can you describe a personal attribute that helped you maintain your 
weight loss? 
6. How do you feel about your body? About your health? 
2. Behavioral 
1. What activities reinforce your motivation to eat healthy meals and/or move your 
body? 
2. What behaviors have helped you be successful? 
3. How have your behaviors changed since completing the study? 
4. Describe the process of changing your behavior long term. 
5. What were your expectations of losing weight? Were those expectations met? 
6. Has COVID-19 impacted your ability to maintain your nutrition and physical 
activity habits? If so, how? If not, why?  
3. Environmental 
1. What outside yourself helps you to maintain your weight loss or achieve other 
goals? 
2. What outside yourself is crucial to your success? 
3. Describe the support outside of yourself that helps you maintain 
activities/choices that support your health? 
4. Did you experience an event, idea, or person that reinforced your commitment 
to maintaining weight loss? 
5. How does your culture/community affect your eating/exercise habits? 
6. How does your family/friends influence your behavior? 
7. How did your social support network (friends, family, colleagues) react to your 
weight loss? 
 

Sample semi-structured interview guide for the Non-maintainers 
Personal 
      1. What thoughts do you have about your weight journey since you completed the study? 
      2. How do you feel about your body? About your health? About your current weight? 
      3. What about your personality or experiences affects your health/nutrition choices? 
      4. What has worked for you in the past regarding _______(exercise, weight loss, diet)? 
      5. Has there been a time when you were successful and how did that make you feel? 
      6. If you could change one thing today regarding your health, what would that be? 
      7. Is there anything about your health or your weight that concerns you? 
      8. Describe your approach to other goals you have 
          a) Why do you think you were able to achieve those goals? 
          b) Why do you think you were not able to achieve those goals? 
 
Behavioral 
      1. Have you maintained any habits that you acquired during the study? Why or why not?  
      2. Do you cook and if so, do you enjoy it? 
          a) If so, how would you describe your cooking skills? 
Beginner/intermediate/advanced/expert 
      3. What about diet is important to you? 
          a) What health habits are important to you? 
      4. What concerns, if any, do you have about your current level of physical activity? 
      5. What concerns, if any, do you have about your current eating habits? 
      6. When you tried ____(dieting, Eggspdite) in the past, what got in the way? 
           a) If it was a person - what would it take to get them on board with your habit changes? 
           b) If it was finances/access to food - have you ever used community resources to help 
improve your access to food? 
      7. Describe your personal process of trying to adopt long lasting behavior change.  
      8. What were your expectations of losing weight?  
          a) What were you hoping to change, achieve?  
          b) Were those expectations met? Not met?  
      9. Has COVID-19 impacted your nutrition and/or physical activity? If so, how? If not, why?  
Environment  
      1. How does your family/friends influence your eating/exercise habits? 
      2. What do you feel are your main barriers to healthy eating/exercise? 
      3. How does your culture/community affect your eating/exercise habits? 
      4. While you were participating in the _______ study, where did your support come from? 
      5. When you were in the study how did your social support network (friends, family, 
colleagues) react? 
 
 
AIM 1b: Develop novel, customizable tele-programs of nutrition and exercise to maintain and 
extend legacy benefits of a recent obesity intervention: Creation of tele-intervention 
protocols for testing 

The information gained from the individual interventions, combined with our expertise in 
nutrition and exercise interventions in obese, frail older adults and our established experts in 
tele-health and behavior science will inform the content of Tele-nutrition and Tele-exercise 
Legacy Intervention. Furthemore, protocol development for the Legacy Intervention will 
employ Social Cognitive Theory3 components that are key to maintaining behavior change. 
Expected Findings: we anticipate the “Legacy Intervention” will include cognitive behavioral 
strategies (e.g., goal setting, self-monitoring, and social support) and draw upon a toolbox of e-
approaches, including daily and weekly text reminders, virtual exercise classes, virtual individual 
and group nutrition classes, and step tracking device.  
 
AIM 2: Determine the feasibility, acceptability, and fidelity of a 3-month lifestyle enhancing 
tele-intervention: Pilot intervention trial 
The 3-month tele-nutrition and tele-physical activity intervention developed in Aim 1b will be 
pilot-tested in older adults who, within the last 3 months, successfully completed a lifestyle 
intervention and meet the inclusion criteria in Table 3. 
Successful completion of a lifestyle intervention: lost at least 3% body weight and increased 
SPPB score by 1 point or increased their 6MWT by 50 meters from their baseline.  
  
We will enroll participants until we reach a total of 10 study completers. We anticipate 
enrolling approximately 15, allowing for a 30% dropout rate. 
Table 3. Inclusion/Exclusion Criteria Aim 2  
Inclusion Criteria 
Exclusion Criteria  
• 
Participated in a weight loss 
intervention in the last 3 
months and lost ≥ 3% body 
weight and improved SPPB 
score by ≥ 1 point or 6MWT by 
≥ 50 metes (Perera et al. J Am 
Geriatr Soc. 2006;54(5):743-9) 
• 
Age ≥ 60 
• 
Able to speak and understand 
spoken and written English. 
• 
Able to record dietary intake 
and weight 
• 
Presence of unstable or symptomatic life-
threatening illness 
• 
Neurological conditions causing functional 
impairment, including Parkinson’s disease, 
multiple sclerosis, and permanent disability due 
to stroke 
• 
Inability to complete physical function 
assessment  
• 
No access to internet connection to participate 
in the tele-intervention  
• 
Unable or unwilling to use provided tablet to 
participant in tele-intervention 
• 
History of cognitive impairment  
 
 
Setting: Screening will be conducted by telephone. Consents will be sent electronically and a 
consent presentation will be conducted virtually using Duke Zoom. Consented participants will 
come to the Duke Center for Living Stedman Center to receive their tablet and Garmin watch 
and will be provided an overview of how to login to the tele-intervention. All additional 
interaction will occur virtually.  
Measurements: 

Baseline: Baseline outcomes will be assessed after participant picks up tablet and Garmin 
watch. Using Duke Zoom, participants will be guided through their functional assessment and 
will be asked to complete their questionnaires using a REDcap link that was sent to them.  
Midpoint (6 weeks) and Endpoint (12 weeks): outcomes will be collected virtually as they were 
at baseline  
 
Outcome Measures 

Table 4: Aim 2 Outcome Measures and Collection Points 
Measurement/Procedure 
Time Points 
Method 
Function and Activity  
SPPB  
0, 6, 12 weeks Balance (side-by-side, semi-tandem, tandem), gait speed (3-
meter timed walk), strength (chair stands).  
6-minute walk test (aerobic 
endurance) 
0, 6, 12 weeks Farthest distance walked as possible in 6 minutes (measured 
using Garmin watch)  
Average Step Count  
Weekly  
Average weekly step count will be determined using Garmin 
VivoSmart3 watch  
Body Weight and Diet 
Body weight 
Weekly  
Same scale, light clothing and no shoes, measured to nearest 0.1 
kg 
3-day diet record;  
Daily food journal (Adherence) 
0,6, 12 weeks 
3-day diet record by multiple pass; analyzed Food Processor 
(Version 10.13, 2013; ESHA Research); Daily food journal 
assessed by registered dietitian  
Function, body composition 
SPPB (6, 64, 66) 
0, 6, 12 weeks Balance (side-by-side, semi-tandem, tandem), gait speed (4-
meter timed walk), strength (chair stands).  
6-minute walk test (aerobic 
endurance) 
0, 6, 12 weeks As many walking laps as possible in six minutes between cones 
placed 40 meters apart 
Questionnaires 
Quality of Life; Mood; Depression; 
Stress; Sleep; Life Satisfaction 
0, 6, 12 weeks SF-36; CES-D; Perceived stress; Pittsburgh sleep 
Acceptability  
Participant Satisfaction 
Questionnaire 
12 weeks  
Participants will asked to rate their satisfaction using a five point 
Likert scale (very dissatisfied; dissatisfied; neutral; satisfied; very 
satisfied) on a) satisfaction with the delivery of the tele-nutrition 
intervention, b) satisfaction with the delivery of the tele-exercise 
intervention c) satisfaction with their ability to maintain their 
physical function d) satisfaction with their ability to maintain 
their weight loss e) satisfaction with interactions with the 
registered dietitian. 
Feedback Session  
12 weeks  
Using an interview guide we will examine aspects of the program 
in-depth from participants’ perspectives. 
Attrition Rate  
12 weeks  
Attrition Rate (%) = (Number of dropouts ÷ number of total 
participants) x 100 
Feasibility  
Feasibility  
12 weeks 
Proportion of participants recruited will be calculated as the 
number of patients deemed potentially eligible and contacted for 
enrollment divided by the total number of patients enrolled. 
Fidelity  
Adherence to tele-nutrition 
intervention  
12 weeks  
Proportion adherent to the tele-nutrition intervention will be 
computed by dividing the number of participants who 
maintained their weight by the total number of participants  
Adherence to the tele-exercise 
intervention  
12 weeks  
Proportion adherent to the tele-exercise intervention will be 
computed by dividing the number of participants who 
maintained their functional status by the total number of 
participants 
Retention  
12 weeks  
Proportion retention will be computed by dividing the number of 
retained subjects at the end of the intervention by the total 
number of participants  

Risk/Benefit Assessment  
The risk to human subjects for participation in this study is minimal compared to the potential 
health benefits they will receive from participating in the interventions and receiving detailed 
nutrition and exercise information.  
 
Physical Risks:  
Low-Intensity Chair Tele-Exercise: All physical activity and exercise involves some risk; however, 
the low-intensity chair exercises will be lead by trained certified group exercise instructors and 
carefully designed to ensure maximum safety. Participants will be instructed to only do the 
activities they feel comfortable doing and will asked to provide their rate of perceived exertion 
multiple times throughout the exercise class to allow for close monitoring. Furthermore, the 
exercise prescription described in the present study approximate the standard physical activity 
recommendations for older adults. The most common adverse consequences associated with 
participation in physical activity are fatigue, muscle soreness.  
Participants will be provided contact information for Dr. Starr and all study team members and 
encouraged to communicate with them about any concerns regarding any aspects of the study. 
 All reported events will be recorded in the adverse event log (including the subject’s name, 
date, and event description) and the PI and study team will be notified. All health occurrences 
will be recorded and regularly reviewed by the study staff and reported to the IRB according to 
IRB guidelines. 
 
Psychological Risks 
Semi-Structured Interviews: Participants may feel uncomfortable by questions asked during 
interview. We will inform all participants that they can refuse any of the questions at any time 
during the study and they will be allowed to take a break during the interview if needed. 
 
Legal Risks 
The present study poses no legal risks to participants. 
 
Economic Risks 
The present study poses no economic risks to participants. 
 
Social Risks 
Loss of confidentiality is always a potential risk and every effort will be made to keep 
participant information confidential. To reduce loss of confidentiality, participants will be 
instructed to not use the provided tablet for personal use. Furthermore, the tablet will be 
cleaned to remove any personal information.  
 
Vulnerable Populations 
Vulnerable populations will not be eligible for participation in this study. 
 
Alternatives to Participation 
The only alternative is non-participation. Participants may choose not to participate in the 
study, or, if they agree to participate in the study, they may withdraw from the study at any 

time. Their decision not to participate or to withdraw from the study will not involve any 
penalty or loss of benefits to which they are entitled, and will not affect their access to health 
care at Duke. If they withdraw from the study, no new data will be collected for study purposes 
other than data needed to keep track of their withdrawal. If they withdraw from the study all 
data and samples that have already been collected for study purposes will be used unless a 
written request for all data to be destroyed is received. Participants who withdraw from 
the study will discontinue all study procedures. 
 
Benefits 
A number of potential health benefits that may accrue to participants and important scientific 
knowledge will likely result from this work. We expect that participants will achieve lifestyle 
modifications that could be sustained as a part of their personal health regimen in the setting of 
their community environment. Additionally, information collected from this study will benefit 
others through a greater understanding of how to best maintain physical function following an 
intensive weight loss intervention.  
 
 
6 Statistical Plan 
This is a pilot study that will be used to generate preliminary data for a larger clinical trial. The 
data analysis for both Aims are outlined below:  
Aim1a: A qualitative analytical approach is well suited to exploring concepts related to a 
complex process (long-term adherence to weight loss and physical activity). We plan to use 
applied thematic analysis, organizing the data in response to the a priori questions contained in 
the semi-structured interviews and interview guides. Interview guide questions will be 
developed utilizing input from the Interventionist and socio-behavioral researchers. We will use 
applied thematic analysis to analyze the data. Audio recordings will be transcribed verbatim 
following a transcription protocol. Two analysts will use NVivo 12 software to develop and 
apply structural (a priori) codes to segment participants’ narratives into conceptual categories 
(e.g., all text describing a similar concept, such as psychosocial factors). Next, analysts will 
identify and apply content-driven (emergent) codes to the text for each of the conceptual 
categories (e.g., potential themes related to psychosocial factors). Inter-coder reliability 
assessments will be conducted on approximately 25% of transcripts during both structural and 
content coding. Discrepancies in coding will be resolved through analyst discussions; transcripts 
will be re-coded and the codebook revised accordingly. Once coding is complete, we will 
examine code frequencies across transcripts to identify salient factors for each interview group, 
followed by comparing and contrasting factors between groups. To conclude analyses, 
analytical memos and reports will be written, describing the factors influencing success in 
maintaining the functional benefits of obesity treatment over time, together with illustrative 
quotes. 
 
Aim 2. Feasibility: Proportion of participants recruited will be calculated as the number of 
participants deemed potentially eligible and contacted for enrollment divided by the total 
number of participants enrolled. Proportion retention will be computed by dividing the number 

of retained participants at the end of the intervention by the total number randomized into the 
study. Fidelity: Proportion 
adherent 
to 
the 
tele-nutrition 
diet 
and 
tele-exercise 
intervention. Acceptability: Levels of attrition will be calculated and satisfaction will be assessed 
with survey items on a Likert-scale and focus group.  
We will calculate these rates of retention, adherence, and attrition and their respective 
confidence intervals overall. While non-powerful, in a series of sensitivity tests, we will assess if 
adherence overall was impacted by demographic/socioeconomic variables. 
We will employ a simplified applied thematic analysis for the feedback session recording and 
transcript following a similar approach to 1a above, less the NVivo interface and group 
comparison 
given 
the 
single 
group. 
Assessment 
of 
our 
measures 
used 
with 
screening/recruitment, 
adherence/retention, 
attrition/participant 
satisfaction, 
physical 
function, and self-efficacy will inform our feedback session interview guide where we will 
examine aspects of the program in-depth from participants’ perspectives. This will allow us to 
examine individual level success through our objective intervention documentation in tandem 
with rich data from participants during the feedback session. 
For physical function outcome measures a repeated measures analysis of variance will be 
employed to determine differences between timepoints, followed by pairwise comparison of 
each time point to the baseline time point.   
 
7 Safety and Adverse Events 
Oversight and Reporting: Dr. Starr will be responsible for the operation of this research study 
according to the study’s protocol and IRB policies. Any serious adverse event, study-related or 
not study related will be reported via email to the Duke University IRB within 24 hours of 
learning about the event. Within 5 business days following the initial report, a Notification of a 
Problem or Event Requiring Prompt Reporting Form will be sent to the Duke IRB. This study is 
not an intervention and thus will not have a safety monitoring board, however the investigator 
will submit the number of adverse events, complaints, withdrawals, and protocol violations to 
the Duke University IRB. In addition, the PIs will review quarterly adverse event reports and 
make adjustments to the protocol if needed.  
 
We expect adverse events to be limited to loss of protected health information. The study team 
has outlined procedures for data management to protect against loss of data (detailed below). 
Breaches in data security will be reported within 24 hours of detection, and a plan for 
management of the breach and modification of data security procedures will be developed 
within 3 business days, if applicable. 
8 Data Handling and Record Keeping  
8.1 Confidentiality 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).   
 

Data Storage: In order to assure each subject’s confidentiality, data collected under this 
protocol will be coded and stored in a secure locked file cabinet located in the Center for Aging 
Nutrition Lab in the sub-basement of the Busse Building, Duke South.  Access to subject files will 
be limited to those directly related to the conduct of this study.  Electronic versions of these 
data will be stored on a limited access, password protected, secure server with coded patient 
identifiers. Study participants will be assigned a code number that will be linked to their name. 
Only authorized study personnel will have access to the linked name-code key. Data will be 
marked solely with the participant’s code number.  
 
Protected health information (PHI) collected from this study includes name, dates, email, 
medical record number, and phone numbers.  PHI obtained from interviews and subjects’ 
medical records will be recorded directly into the study’s database (e.g., REDCap, Excel, MS 
Access). 
 
We will develop Standard Operating Procedures for data management to protect against data 
loss and maintain patient confidentiality. Patient involvement in the study and information 
collected in the context of this research study will be considered confidential. This 
confidentiality will be assured through several mechanisms: Each participant will be assigned a 
de-identified study ID that will be used on study forms. All study forms and paper records that 
contain participant information will be kept in PI’s office in a locked file cabinet which is 
secured and locked when not in use.  Materials that need to be discarded will be destroyed. 
Specifically, compensation will be provided by check or gift card. Subjects will have to complete 
the IRB personal data disclosure form to receive compensation. The form will include social 
security number so it will be stored securely in the PI’s office until it is submitted to employee 
travel and reimbursement (ET&R) via secure drop box. Upon receiving of payment, the social 
security number will be redacted from the form immediately. Forms will be submitted to ET&R 
every 2 to 4 weeks.  
 
Access to all participant data and information will be restricted to authorized study personnel 
and covered entities identified protocol. Access to computerized data will be password 
protected and staff members will be assigned passwords that allow them access to only those 
elements of the data management system to which they are authorized. Data will be managed 
by Duke Medicine Department supported IT service. Study personnel will maintain certification 
with the Duke IRB that they have completed training in research ethics, which includes training 
on confidentiality. Participants will not be identified by name in any reports or publications, nor 
will data be presented in such a way that the identity of individual participants can be inferred. 
For data storage and collection, we will utilize Microsoft Access 2010 or Excel, or a REDcap 
database. Identifiers will be removed from analytic data sets after data merging, with personal 
identifiers kept in a separate location from the analytic data.  No individual subject will be 
identified in any reports from the study. Data storage computer will be password protected. 
Files containing names and addresses will have a separate password and will be accessible only 
to personnel who need to contact subjects. All data files will be organized by study ID number 
and have no names or other identification attached. This ID number links all computerized 
study records. 

 
Audio files will be recorded using a DigiTalks USB Recorder and saved to the project’s secure 
folder behind the Duke server. Only IRB-approved key personnel will have access to the 
recorder, the audio recordings and transcribed data. Audio files will be transcribed by GMR 
Transcription Services, Inc. and directly uploaded to their secure website. GMR’s transcription 
system uses 256 bit SSL and data are automatically encrypted. Duke staff will have a secure 
individual account that allows audio files and completed transcripts to be uploaded and ensures 
complete confidentiality and security at all times. GMR’s transcriptionists only have access to 
the files assigned to them. 
8.1 Records Retention 
All study forms, paper records, and transcription files will be retained for at least 6 years and 
safely destroyed thereafter to protect confidentiality. 
9 Study Monitoring, Auditing, and Inspecting 
9.1 Study Monitoring Plan 
The PI, with the assistance of study staff, will be responsible for overall monitoring of the data. 
Any unanticipated problems, deviations or protocol changes will be reported by the PI to the 
IRB within 24 hours.  
 
10 Ethical Considerations 
This study is to be conducted according to US and international standards of Good Clinical 
Practice (FDA Title 21 part 312 and International Conference on Harmonization guidelines), 
applicable government regulations and Institutional research policies and procedures. 
 
This protocol and any amendments will be submitted to a properly constituted independent 
Ethics Committee (EC) or Institutional Review Board (IRB), in agreement with local legal 
prescriptions, for formal approval of the study conduct.  The decision of the EC/IRB concerning 
the conduct of the study will be made in writing to the investigator and a copy of this decision 
will be provided to the sponsor before commencement of this study.  The investigator should 
provide a list of EC/IRB members and their affiliate to the sponsor. 
 
All subjects for this study will be provided a copy of the consent form and written consent will 
be obtained from each participant.  
 
11 Study Finances 
11.1 Funding Source 
This study is financed through a grant from the US National Institutes of Health.  

11.2 Conflict of Interest 
The investigators have no conflict of interest to report. 
11.3 Subject Stipends or Payments 
Aim 1a: Participants will be compensated $40.00 for completing functional assessment and 
semi-structured interview.  
Aim 2: Participants will be compensated up to $100 for completing Aim 2 
$25.00 following baseline testing  
$25.00 following midpoint (6weeks) testing  
$50.00 following endpoint (12 weeks) testing  
Participants will also be able to keep their Gramin watch 
12 Publication Plan 
Dr. Starr holds the primary responsibility for publishing manuscripts from this study. 
13 References 
References  
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Alley DE, Chang VW. The changing relationship of obesity and disability, 1988-2004. 
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Porter Starr KN, Pierper CR, Orenduff M, et al. Improved function with enhanced protein 
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Bales CW, Porter Starr KN, Orenduff MC, et al. Influence of Protein Intake, Race, and Age 
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Porter Starr KN, Connelly MA, Orenduff M, et al. Impact on cardiometabolic risk of a 
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Saldaña J. The coding manual for qualitative researchers. London, UK: Sage; 2016. 
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McLeroy KR, Bibeau D, Steckler A, Glanz K. An ecological perspective on health 
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