Cognitive Strategies for Weight Loss

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
The Miriam Hospital
Study ID
NCT05799846
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Standard Behavioral Weight Loss Intervention — BEHAVIORAL
    12-month online behavioral weight loss intervention
  • PREVENT Behavioral Weight Loss Intervention — BEHAVIORAL
    12-month online behavioral weight loss intervention focused on preventing future negative consequences of obesity
  • PROMOTE Behavioral Weight Loss Intervention — BEHAVIORAL
    12-month online behavioral weight loss intervention focused on promoting future benefits of maintaining a healthy weight

Study Details

The goal of this clinical trial is to compare weight change and other related outcomes associated with three different behavioral weight loss interventions (STANDARD Behavioral, PREVENT, and PROMOTE) in adults with obesity. The main questions it aims to answer are: * Which of the three Internet-delivered weight loss programs results in the greatest weight loss? * How do key weight-related behaviors (e.g., adherence, diet, physical activity) differ across the arms? * What individual characteristics predict success in each arm? * What are the underlying mechanisms of each approach? * Are there any potential adverse outcomes associated with any of the conditions (e.g., depression, weight stigmatization, increased body image concerns). Participants will: * signed informed consent * complete a baseline assessment * be randomized to 12 months of either Standard iBWL, PREVENT or PROMOTE * complete a training workshop to learn arm-specific cognitive strategies * complete a 12-month Internet-delivered weight loss program, requiring self-monitoring of intake and exercise and viewing of 12 weekly lessons followed by 9 monthly lessons * complete an assessment at 3 months (during treatment) * complete a refresher workshop on arm-specific cognitive strategies at 3 months * complete an assessment at 6 months (during treatment), 12 months (at the conclusion of treatment), and 18 months (6 months after treatment

Key Dates

Start date
Mar 1, 2023
Status verified
Mar 2023
Primary completion
May 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: STANDARD Behavioral
    This is a 12-month Internet-delivered behavioral weight loss (iBWL) program that has been used in numerous studies and is currently considered our 'standard' treatment. Participants are asked to adhere to calorie and physical activity (PA) goals and are required to self-monitor weight, intake, and PA daily via a study website. Participants will have a training session prior to beginning iBWL to learn about the website and their specific weight-related goals. The iBWL includes 3 months of weekly video lessons teaching skills to modify eating and PA behaviors. These lessons and individualized feedback to participants incorporate key BWL strategies. Participants will then have a 'refresher' training session at 3 months to discuss standard behavioral weight loss strategies and help control for contact across arms. For the remainder of the program (months 4-12) participants will have monthly lessons, self-monitoring (tracking calories and PA 1 wk/month) and feedback.
  • Experimental: PREVENT
    This is a 12-month Internet-delivered behavioral weight loss (iBWL) program in which participants are asked to adhere to calorie and physical activity (PA) goals and are required to self-monitor weight, intake, and PA daily via a study website. Additionally, PREVENT uses a future-oriented cognitive strategy featuring Episodic Future Thinking (EFT) to focus on long-term negative consequences of unhealthy choices. Participants will receive training in PREVENT strategies prior to beginning iBWL. The iBWL includes 3 months of weekly video lessons teaching skills to modify eating and PA behaviors. These lessons and individualized feedback to participants are framed according to PREVENT (i.e., focusing on avoiding long-term consequences of unhealthy choices) and include specific exercises and reminders to use the strategy. Participants will then have a 'refresher' training session at 3 months, followed by monthly lessons, self-monitoring (tracking calories and PA 1 wk/month) and feedback.
  • Experimental: PROMOTE
    This is a 12-month Internet-delivered behavioral weight loss (iBWL) program in which participants are asked to adhere to calorie and physical activity (PA) goals and are required to self-monitor weight, intake, and activity daily via a study website. Additionally, PROMOTE uses a future-oriented cognitive strategy featuring Episodic Future Thinking (EFT) to focus on long-term benefits of healthy choices. Participants will receive cognitive training in PROMOTE prior to beginning iBWL. The iBWL includes 3 months of weekly video lessons teaching skills to modify eating and activity behaviors. These lessons and individualized feedback to participants are framed according to PROMOTE (i.e., focusing on achieving long-term benefits of healthy choices) and include specific exercises and reminders to use the strategy. Participants will then have a 'refresher' training at 3 months, followed by monthly lessons, self-monitoring (tracking calories and PA 1 wk/month), and feedback.

Primary Outcome Measure

Percent Weight Change at 3 months [ Time Frame: 3 months after randomization ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weight Control & Diabetes Research CenterProvidenceRhode Island02903
Kathryn E Demos McDermott, PhD
[email protected]
401-793-8939

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