- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06023537
Using Technology to Investigate Lapses in a Weight Loss Program Among Individuals With Overweight and Obesity
March 24, 2026 updated by: Rebecca Crochiere, Williams College
Using Technology to Investigate Dietary and Physical Activity Lapses in a Behavioral Weight Loss Program
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
119
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Williamstown, Massachusetts, United States, 01267
- Health Lab, Psychology Department, Williams College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Behavioral Weight Loss Intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity lapse/intention-behavior gap
Time Frame: 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.
|
up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dietary lapse
Time Frame: 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).
|
up to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rebecca J Crochiere, PhD, Williams College
Study record dates
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 Major Dates
Study Start (Actual)
July 11, 2023
Primary Completion (Actual)
August 5, 2025
Study Completion (Actual)
August 5, 2025
Study Registration Dates
First Submitted
August 21, 2023
First Submitted That Met QC Criteria
August 28, 2023
First Posted (Actual)
September 5, 2023
Study Record Updates
Last Update Posted (Actual)
March 27, 2026
Last Update Submitted That Met QC Criteria
March 24, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified data and analytic code from this study are available (as allowable according to Institutional Review Board standards) upon reasonable request by emailing the principal investigator.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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