Using Technology to Investigate Lapses in a Weight Loss Program Among Individuals With Overweight and Obesity

Sponsor

Williams College (Other)

Overall Status

Recruiting

CT.gov ID

NCT06023537

Collaborator

Temple University (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Approximately 70% of American adults have overweight/obesity, which increases risk of major medical issues and preventable death (Abdelaal et. al, 2017). Many individuals with overweight/obesity attempt to lose weight through behavioral strategies, e.g., adopting a reduced-calorie diet and/or increased physical activity. However, it is exceedingly difficult to consistently adhere to a reduced-calorie diet and high levels of physical activity; as such, most individuals attempting to lose weight via these methods experience repeated instances of non-adherence, i.e., dietary and physical activity lapses. These lapses are a core driver of weight loss failure, undermining individuals' ability to achieve weight control (Forman et al, 2017). As such, it is important to understand what predicts these lapses, which in turn allows for better lapse prevention. The current study proposes to measure these risk factors in an ecologically valid manner, i.e., in the moment they occur and in the context of individuals' everyday lives, using advanced technology. Specifically, the current study will use ecological momentary assessments (EMA; brief, repeated surveys delivered in one's natural environment, typically via a smartphone) and sensor technology (e.g., Fitbit and sensors on smartphone devices) to measure momentary risk factors of dietary and physical activity lapse, as well as the lapses themselves. Findings from this research project will lay the groundwork for a sophisticated just-in-time adaptive intervention (JITAI), a tailored, personalized intervention that targets momentary risk factors (e.g., cravings) via in-the-moment support, thereby reducing lapse occurrence and improving adherence to behavioral weight control prescriptions.

Condition or Disease	Intervention/Treatment	Phase
Obesity Weight Loss	Behavioral: Behavioral weight loss program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Using Technology to Investigate Dietary and Physical Activity Lapses in a Behavioral Weight Loss Program

Actual Study Start Date :

Jul 11, 2023

Anticipated Primary Completion Date :

May 10, 2024

Anticipated Study Completion Date :

Jun 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Behavioral Weight Loss Intervention	Behavioral: Behavioral weight loss program All participants will participate in the same remote, behavioral weight loss program. As part of the baseline assessment, participants will be asked to watch a series of custom-made videos on the study's dietary and physical activity prescriptions, dietary self-monitoring, self-weighing, and cognitive-behavioral skills to facilitate engagement in study prescriptions. Participants will be prescribed a reduced-calorie diet that will be individualized based on the individual's starting weight and weight loss goal (recommended goal of 5-10% weight loss over 12 weeks). Participants also will be prescribed a goal of 150 minutes of moderate-to-vigorous physical activity per week. They are also given, free of cost, a Fitbit Charge 5 health tracker, the Fitbit Aria Air digital scale, and a MyFitnessPal Premium subscription for the duration of the study.

Arm

Intervention/Treatment

Experimental: Behavioral Weight Loss Intervention

Behavioral: Behavioral weight loss program

All participants will participate in the same remote, behavioral weight loss program. As part of the baseline assessment, participants will be asked to watch a series of custom-made videos on the study's dietary and physical activity prescriptions, dietary self-monitoring, self-weighing, and cognitive-behavioral skills to facilitate engagement in study prescriptions. Participants will be prescribed a reduced-calorie diet that will be individualized based on the individual's starting weight and weight loss goal (recommended goal of 5-10% weight loss over 12 weeks). Participants also will be prescribed a goal of 150 minutes of moderate-to-vigorous physical activity per week. They are also given, free of cost, a Fitbit Charge 5 health tracker, the Fitbit Aria Air digital scale, and a MyFitnessPal Premium subscription for the duration of the study.

Outcome Measures

Primary Outcome Measures

Physical activity lapse/intention-behavior gap [up to 12 weeks]
Physical activity lapse/intention-behavior gap will be measured using ecological momentary assessment (EMA; brief, smartphone-delivered surveys) and accelerometers. EMA surveys will be delivered in 2-week bursts at the beginning, middle, and end of treatment. There will be 6 EMA surveys delivered every 2-3 hours throughout the day. Each EMA survey will ask about the participant's intention to engage in moderate-to-vigorous physical activity (MVPA) in the next 2-3 hours and actual engagement in MVPA. Actual MVPA also will be measured through accelerometers (Fitbits). Thus, by measuring intention to engage in MVPA in the next 2-3 hours at Time 1 (e.g., EMA survey at 9:00am) and if the participant actually engaged in MVPA via accelerometer and EMA at Time 2 (2-3 hours later, e.g., at 12:00pm), we can detect a physical activity intention-behavior gap or physical activity lapse.

Secondary Outcome Measures

Dietary lapse [up to 12 weeks]
A dietary lapse will be operationalized as exceeding an individualized calorie target for a meal/snack. Specifically, participants will be assigned a reduced-calorie diet to facilitate weight control and each will be prescribed a personalized daily calorie target. That target will then be divvied up into individual calorie targets for 3 meals and 2 snacks daily (e.g., 15% of daily calorie goal allotted for breakfast, 25% for lunch, 40% for dinner, and 10% for each of two snacks). If a participant exceeds one of these meal-specific calorie targets, it is considered a dietary lapse. Participants will log everything they eat and drink in MyFitnessPal, which automatically calculates calories and stores participant's calorie goals for meals/snacks; thus, lapses can be identified when a participant exceeds a calorie target for a meal/snack in MyFitnessPal. Participants also will report dietary lapses via EMA surveys (see above for more information about EMA surveys).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Current BMI = 27-50 kg/m2
Adult (aged 18-65)
Lives in the United States
Possession of a smartphone with a data plan that allows for app data collection
Ability to understand and provide informed consent
Proficiency in speaking, reading, and writing English

Exclusion Criteria:

Presently involved in another weight loss program
Currently pregnant or plan to become pregnant within the study period
Have a medical condition or psychiatric symptoms that: may pose a risk to the participant during the program; cause a change in weight, appetite, or eating behavior; or limit ability to comply with the program
Endorse eating disordered behavior, including loss of control (LOC) eating, or the subjective experience that one cannot control how much food he or she consumes
Have experienced a recent (i.e., within the last 3 months) change in a weight-influencing medication