Program for Fully Understanding Eating and Lifestyle Change (FUEL)
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.
🗓️ Study Start (Actual)
31 October 2022
🗓️ Primary Completion (Estimated)
31 January 2027
✅ Study Completion (Estimated)
30 April 2027
👥 Enrollment (Estimated)
150
🔬 Study Type
INTERVENTIONAL
📊 Phase
NA
Locations:
📍
Providence, Rhode Island, United States
Description
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:
18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
26 September 2022
- First Submitted that Met QC Criteria
28 September 2022
- First Posted
30 September 2022
Study Record Updates
- Last Update Submitted that Met QC Criteria
12 April 2023
- Last Update Posted
18 April 2023
- Last Verified
April 2023