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

Primary Purpose

Obesity, Weight Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral weight loss program
Sponsored by
Williams College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight Loss, Behavioral Treatment, Dietary Lapse, Physical Activity Lapse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Health Lab, Psychology Department, Williams CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Behavioral Weight Loss Intervention

Arm Description

Outcomes

Primary Outcome Measures

Physical activity lapse/intention-behavior gap
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
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).

Full Information

First Posted
August 21, 2023
Last Updated
September 10, 2023
Sponsor
Williams College
Collaborators
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT06023537
Brief Title
Using Technology to Investigate Lapses in a Weight Loss Program Among Individuals With Overweight and Obesity
Official Title
Using Technology to Investigate Dietary and Physical Activity Lapses in a Behavioral Weight Loss Program
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
May 10, 2024 (Anticipated)
Study Completion Date
June 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Williams College
Collaborators
Temple University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
Obesity, Weight Loss, Behavioral Treatment, Dietary Lapse, Physical Activity Lapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Weight Loss Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Behavioral weight loss program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical activity lapse/intention-behavior gap
Description
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.
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Dietary lapse
Description
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).
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca J Crochiere, PhD
Phone
413-597-2847
Email
williamshealthlab@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca J Crochiere, PhD
Organizational Affiliation
Williams College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Lab, Psychology Department, Williams College
City
Williamstown
State/Province
Massachusetts
ZIP/Postal Code
01267
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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

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