Clinical trial NCT05562427: Program for Fully Understanding Eating and Lifestyle Change (FUEL)
Official title: Using Multimodal Real-Time Assessment to Phenotype Dietary Non-Adherence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Diet
Digital health
Ecological momentary assessment
Behavioral phenotyping
Wearable sensors
Geolocation
Smartphone
Passive sensing
Eating behavior
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-09-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in dietary lapses
timeFrame: Baseline, 3 months, 6 months, 12 months, and 18 months
Secondary outcomes:
measure: Change in weight
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in energy intake
timeFrame: Baseline, 3 months, 6 months, 12 months, and 18 months
Other outcomes:
measure: Height
timeFrame: Baseline, 3 months, 6 months, 12 months, and 18 months
measure: Change in affect levels
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in energy levels
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in stress levels
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in motivation levels
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in self-efficacy
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in distorted thinking patterns
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in self-compassion
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in executive functioning
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in homeostatic hunger
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in hedonic hunger
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in satiety
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in food cravings
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in dietary composition
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in alcohol intake
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in social support
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in television watching habits
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in immediate food availability
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in adherence to Behavioral Obesity Treatment
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Demographic Information
timeFrame: Baseline
measure: Change in basal metabolic rate
timeFrame: Baseline, 3 months, 6 months, 12 months, and 18 months
measure: Neighborhood Socioeconomic Position
timeFrame: Baseline
measure: Change in objective eating behavior
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in objective physical activity
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in objective sedentary behavior
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in objective sleep time
timeFrame: Baseline, 3 months, 6 months, 12 months, and 18 months
measure: Change in objective sleep efficiency
timeFrame: Baseline, 3 months, 6 months, 12 months, and 18 months
measure: Change in location
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
measure: Change in food accessibility
timeFrame: Baseline, 3 months, 6 months,12 months, and 18 months
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
References: