Clinical trial

Cognitive Strategies for Weight Loss

Recruiting now · Not applicable · 1 countries · Registry ID NCT05799846

Recruiting nowNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersAccepted

ConditionObesity

Full registry criteria

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.

Treatments and study arms

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

Primary outcomes

Percent Weight Change at 3 months3 months after randomization

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

Percent Weight Change at 6 months6 months after randomization

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

Percent Weight Change at 12 months12 months after randomization

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

Percent Weight Change Post-Treatment18 months after randomization

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Weight Control & Diabetes Research Center🇺🇸 Providence, Rhode Island, United States

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Kathryn E Demos McDermott, PhDContact

Email · Call 4017938939