Program for Fully Understanding Eating and Lifestyle Change (FUEL)

NCT05562427 | Active Not Recruiting

• 1 other identifier: R01DK132210
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Diet; Digital health; Ecological momentary assessment; Behavioral phenotyping; Wearable sensors; Geolocation; Smartphone; Passive sensing; Eating behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in weight

  Baseline, 3 months, 6 months,12 months, and 18 months

• Change in energy intake

  Baseline, 3 months, 6 months, 12 months, and 18 months

Other Outcomes (29)

• Height

  Baseline, 3 months, 6 months, 12 months, and 18 months

• Change in affect levels

  Baseline, 3 months, 6 months,12 months, and 18 months

• Change in energy levels

  Baseline, 3 months, 6 months,12 months, and 18 months

Study Arms (1)

1

OTHER

Gold-standard online behavioral weight loss treatment

Behavioral: Gold-Standard Online Behavioral Obesity Treatment

Interventions

Gold-Standard Online Behavioral Obesity Treatment BEHAVIORAL

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.

Also known as: Rx Weight Loss (RxWL)

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-70
• Body mass index (BMI) between 25 and 50 kg/m-squared

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

• Goldstein SP, Mwenda KM, Hoover AW, Shenkle O, Jones RN, Thomas JG. The Fully Understanding Eating and Lifestyle Behaviors (FUEL) trial: Protocol for a cohort study harnessing digital health tools to phenotype dietary non-adherence behaviors during lifestyle intervention. Digit Health. 2024 Aug 21;10:20552076241271783. doi: 10.1177/20552076241271783. eCollection 2024 Jan-Dec.

  PMID: 39175923 DERIVED

MeSH Terms

Conditions

Obesity; Feeding Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 30, 2022
• Study Start: October 31, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)