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

NCT ID: NCT06023537

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-11
• Study Completion Date: 2025-08-14

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.

Conditions

Obesity; Weight Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral Weight Loss Intervention

Group Type: EXPERIMENTAL

Behavioral weight loss program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Temple University

OTHER

Sponsor Role: collaborator

Williams College

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Crochiere

Assistant Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca J Crochiere, PhD

Role: PRINCIPAL_INVESTIGATOR

Williams College

Locations

Health Lab, Psychology Department, Williams College

Williamstown, Massachusetts, United States

Countries

United States

Other Identifiers

2023-08

Identifier Type: -

Identifier Source: org_study_id