Cognitive Strategies for Weight Loss

NCT05799846 | Recruiting

• 2 other identifiers: 1809657-4R01DK128412
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Percent Weight Change at 3 months

  Weight change is the primary outcome in this trial and will be calculated as change from baseline.

  3 months after randomization

• Percent Weight Change at 6 months

  Weight change is the primary outcome in this trial and will be calculated as change from baseline.

  6 months after randomization

• Percent Weight Change at 12 months

  Weight change is the primary outcome in this trial and will be calculated as change from baseline.

  12 months after randomization

• Percent Weight Change Post-Treatment

  Post-treatment weight change will be calculated as percent weight change observed at the 18 month assessment (6 months following treatment completion)

  18 months after randomization

Secondary Outcomes (4)

• Change in Actigraph-measured Physical Activity (PA)

  12 months after randomization

• Change in Dietary Recall

  12 months after randomization

• Intervention Adherence - lessons viewed

  12 months after randomization

• Intervention Adherence - self-monitoring

  12 months after randomization

Study Arms (3)

STANDARD Behavioral

ACTIVE COMPARATOR

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.

Behavioral: Standard Behavioral Weight Loss Intervention

PREVENT

EXPERIMENTAL

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.

Behavioral: PREVENT Behavioral Weight Loss Intervention

PROMOTE

EXPERIMENTAL

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.

Behavioral: PROMOTE Behavioral Weight Loss Intervention

Interventions

Standard Behavioral Weight Loss Intervention BEHAVIORAL

12-month online behavioral weight loss intervention

STANDARD Behavioral

PREVENT Behavioral Weight Loss Intervention BEHAVIORAL

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

PREVENT

PROMOTE Behavioral Weight Loss Intervention BEHAVIORAL

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

PROMOTE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Brown University: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Weight Control & Diabetes Research Center

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Professor (Research)

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: April 5, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 5, 2023

Record last verified: 2023-03

Locations

US (1)