Program for Fully Understanding Eating and Lifestyle Change (FUEL)

Study Overview
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Brief Summary
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This project seeks to better understand dietary lapses (instances of nonadherence to dietary goals), a major cause of poor outcomes during behavioral obesity treatment (BOT). Investigators propose to conduct multimodal real-time assessment of behavioral, psychosocial, and contextual characteristics to uncover lapse phenotypes (i.e., meaningful clusters of lapse behaviors, such as lapsing via overeating vs. lapsing via eating an off-plan food). Using wearable sensors and a smartphone-based assessment platform, this research will identify latent characteristics underlying different phenotypes of dietary lapses reported by individuals who are participating in an online BOT. This study will also evaluate how these emerging lapse phenotypes vary over time, between individuals, and within individuals. Such information will ultimately help the field understand how best to reduce lapses in future treatments (e.g., how much to personalize future interventions for lapse vs. generalizability of lapse phenotypes across individuals). Therefore, this study has three goals. First, investigators aim to establish lapse phenotypes by identifying clusters of behavioral, psychosocial, contextual and individual-level factors (e.g., sex, race) that differentiate lapse behaviors during weight loss and maintenance. Second, the investigators aim to test the association of lapse phenotypes with energy intake and weight change during weight loss and maintenance to determine which lapse phenotypes have the greatest impact on BOT outcomes (e.g. personal, environmental, and behavioral factors). Lastly, investigators aim to evaluate individual variability in the occurrence of lapse phenotypes during weight loss and maintenance to determine the generalizability of lapse phenotypes across individuals. Participants will be recruited through various methods including advertisements in local media, targeted online advertising, advertisements in medical and minority communities, and direct mailers. All participants will receive a well-established online BOT program for 12 months, with a 6-month maintenance period, for a total study participation of 18 months. In conjunction, they will complete 14-day monitoring periods (at baseline, 3 months, 6 months, 12 months, and 18 months) consisting of: 1) repeated daily smartphone surveys to assess personal, environmental, and behavioral factors, including automatic capture of geographic location; 2) wearing two wrist-based sensor devices to passively capture physical activity, sleep, and eating behaviors; and 3) completing telephone-based 24-hour dietary recalls to assess overall energy intake. Weight will be measured at all visits to the research center.

Detailed Description
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The purpose of this 5-year study is to conduct multimodal real-time assessment of behavioral, psychosocial, and contextual characteristics to uncover lapse phenotypes. The data from this project will ultimately inform future personalized interventions to promote dietary adherence by providing critical data on which lapses to target and how to best target them. Participants (N=150) will receive 12 months of online behavioral obesity treatment followed by a 6-month maintenance period (18 months of study participation total). The primary aim is to establish lapse phenotypes by identifying clusters of factors that differentiate lapse behavior. The secondary aim is to evaluate associations of emerging lapse phenotypes with clinical outcomes (e.g., energy intake and weight loss). The investigators will also explore the variability in lapse phenotypes based on data collected from the primary outcome. Participants will be recruited on a rolling basis until the target (N=150) is reached. Participants will be recruited via advertisements in local media (e.g. newspapers, radio) and online advertising (e.g., Google AdWords, social media), flyers and advertisements posted in waiting rooms and exam rooms in primary care offices, informational materials made available as part of the health and wellness program for employees in the Lifespan hospital network, and direct mailings. Interested individuals will be initially screened for eligibility via REDCap (a Lifespan secure website) or via telephone. If a participant appears to be eligible based on their responses to the screening questions, they will receive a follow-up call from the research team to confirm eligibility, describe the study in more detail, and schedule an orientation meeting. If they are not eligible, they will receive a message indicating that they are not eligible for the study and directed to contact the research team if they wish to receive referrals for other weight loss programs. Those who are eligible will be invited to an orientation via the online video chat forum Zoom, where the study will be described, and informed consent obtained. Only after the consent form is signed will any further study procedures be completed. If consent is not given, participant contact information will be immediately removed from the system. After consent is obtained, participants will complete baseline questionnaires via REDCap. Paper surveys will be made available for participants who prefer this option. If a participant elects to use a paper questionnaire, the questionnaire will be sent to the participant's home address. Participants will then complete a 1-week behavioral run-in in which they complete smartphone-based surveys and wear the sensors. This data is for testing only and will not be used in the analysis of primary outcomes. Participants must complete >70% of EMA surveys and wear both devices >10 hrs/day to move forward with the remainder of study procedures. Following consent and successful completion of baseline procedures, participants will attend an in-person kick-off session to assist them in using the online BOT program. Participants will be given access to an online BOT (described further in the Intervention section) for 12 months, with an additional 6 months of no treatment follow-up (intended to serve as a weight maintenance period). During this 18-month study period, participants will complete 5 total assessments at baseline, 3, 6, 12, and 18 months. Each assessment consists of a 14-day monitoring period. There will be 2 visits with trained research staff at the beginning and end of the 14-day monitoring. At the first visit, participants will: have their height/weight measured, receive study equipment (e.g., wearable wrist devices), and undergo training in using study equipment. Participants will be instructed to wear the sensor devices, complete repeated smartphone surveys for 14 days, and complete three non-consecutive telephone-based 24-hour dietary recalls with staff. At the end of 14 days, participants will return for their second visit in which they will: have their weight measured, return study equipment, and receive payment. The research staff do not need to be blinded for study visits because all participants are assigned to the same intervention. Participants will be asked to complete the same assessment procedures at baseline (first two weeks of the online BOT), 3, 6, 12, and 18 months (last two weeks of no- treatment weight maintenance period).

Official Title
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Using Multimodal Real-Time Assessment to Phenotype Dietary Non-Adherence

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Gold-Standard Online Behavioral Obesity Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18-70 Body mass index (BMI) between 25 and 50 kg/m-squared Exclusion Criteria: Has health problems for which weight loss or physical activity is contraindicated Currently pregnant or breastfeeding Currently or recently (< 6 months) enrolled in a commercial weight loss program Weight loss of ≥ 5% of initial body weight in the last 6 months Currently taking weight loss medication, Has history of surgical procedure for weight loss, Has history of a clinically diagnosed eating disorder excluding Binge Eating Disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Gold-standard online behavioral weight loss treatment | Behavioral: Gold-Standard Online Behavioral Obesity Treatment<br>* Rx Weight Loss (RxWL) is an online BOT that consists of: (a) tailored weight loss, calorie, and physical activity goals. (b) 12 weekly 10-15 minute multimedia lessons for training in behavioral weight loss skills followed by 9 monthly lessons for continued weight loss. Lessons incorporate video, animation, audio, quizzes, and exercises for goal setting, planning, and problem-solving. Example topics include restaurant eating, changing the home environment, and obtaining social support. (c) Online tools for self-monitoring weight, diet, and physical activity that interface with popular tracking apps; and (c) Weekly, and eventually monthly, automated feedback on progress to date (delivered as text appearing on the platform). If goals are not met participants receive strategies to improve weight loss, along with encouragement. To ensure engagement, email reminders are sent to participants who have not visited the platform on a given week.<br>* Other names: Rx Weight Loss (RxWL);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dietary lapses | Smartphone-based ecological momentary assessment (EMA) surveys will be used to assess dietary lapses, defined as exceeding a pre-planned calorie target for a given meal or snack. Participants will be asked to report if they experienced a dietary lapse since the last EMA survey. Participants can also initiate a report of a dietary lapse at any time. Participants will also record the time that the lapse occurred. Participants will be asked how would you describe the lapse? and can select all that apply from: 'I ate a larger portion', 'I ate when I hadn't intended', 'I ate a type of food I wanted to avoid', 'I planned to lapse', 'I did not know the calories in the food.' | Baseline, 3 months, 6 months, 12 months, and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Weight will be measured by trained research staff at the research center to the nearest 0.1 kg using a calibrated digital scale. Measurements will be made in light indoor clothing without shoes. | Baseline, 3 months, 6 months,12 months, and 18 months | 
| Change in energy intake | Participants will complete 3 non-consecutive telephone-based 24-hour dietary recalls. Recalled intake will be collected over 2 weekdays and 1 weekend day. The Nutrition Data System for Research (NDSR), a software application developed at the University of Minnesota Nutrition Nutrition Coordinating Center (NCC), will facilitate collection of recalls in a standardized fashion. Dietary intake interviews will be governed by a multiple-pass interview approach during which participants receive 5 opportunities to recall food intake. Recalled intake and independently observed intake are highly correlated, indicating the 24-hour dietary recall is highly valid and considered the goal-standard of dietary assessment. NDSR will generate daily estimates of usual energy intake using the NCC Food and Nutrient Database. | Baseline, 3 months, 6 months, 12 months, and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Digital health, Ecological momentary assessment, Behavioral phenotyping, Wearable sensors, Geolocation, Smartphone, Passive sensing, Eating behavior