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Cognitive Strategies for Weight Loss

Cognitive Strategies for Weight Loss

Recruiting
18-70 years
All
Phase N/A

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Overview

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

Eligibility

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 details
    Obesity

NCT05799846

The Miriam Hospital

27 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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