Recruiting

Cognitive Strategies

Sponsor:

The Miriam Hospital

Code:

NCT05799846

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Standard Behavioral Weight Loss Intervention

PREVENT Behavioral Weight Loss Intervention

PROMOTE Behavioral Weight Loss Intervention

Study Details

Brief summary:

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

Conditions

Obesity

Study ID

NCT05799846

Start date

Mar 1, 2023

Status verified date

Jul, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participants will be between the ages of 18 and 70, have a BMI between 25 and 45 kg/m2, and have regular (i.e., weekly) access to the Internet, defined as owning a smart phone with Internet capabilities, and/or having a broadband or Wi-Fi connection at home or work.

Exclusion Criteria:

  • Exclusionary criteria include: 1) current enrollment in a weight loss program, 2) currently taking weight loss medications, 3) history of bariatric surgery or planned bariatric surgery in the next 18 months, 4) individuals who are pregnant, nursing, or have plans to become pregnant within the next 18 months, 5) individuals planning to relocate outside the area in the next 18 months, 6) any medical condition for which weight loss would be contraindicated, 7) neurological or psychiatric conditions including but not limited to schizophrenia and bipolar disorder, 8) inability to attend assessments at the Weight Control and Diabetes Research Center in Providence, RI.

Individuals with mobility issues, dizziness, or history of heart disease, diabetes, or cancer will be required to provide physician consent prior to enrolling.

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Standard Behavioral Weight Loss Intervention

12-month online behavioral weight loss intervention

PREVENT Behavioral Weight Loss Intervention

12-month online behavioral weight loss intervention focused on preventing future negative consequences of obesity

PROMOTE Behavioral Weight Loss Intervention

12-month online behavioral weight loss intervention focused on promoting future benefits of maintaining a healthy weight

Primary outcome measure

  • Percent Weight Change at 3 months [ Time Frame: 3 months after randomization ]
  • Percent Weight Change at 6 months [ Time Frame: 6 months after randomization ]
  • Percent Weight Change at 12 months [ Time Frame: 12 months after randomization ]
  • Percent Weight Change Post-Treatment [ Time Frame: 18 months after randomization ]

Central Contacts and Locations

Locations

Weight Control & Diabetes Research Center

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Kathryn E Demos McDermott, PhD

4017938939kathryn_demos@brown.edu

More Information

Sponsor

The Miriam Hospital

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2026-07-15.