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Recruiting NCT05799846

Cognitive Strategies for Weight Loss

No phase Interventional Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard Behavioral Weight Loss Intervention, PREVENT Behavioral Weight Loss Intervention, PROMOTE Behavioral Weight Loss Intervention.
Who it may be relevant to
Registry conditions: Obesity. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Adapting Episodic Future Thinking for Behavioral Weight Loss: Comparing Strategies and Characterizing Treatment Response

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

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • Change in Actigraph-measured Physical Activity (PA) [Time frame: 12 months after randomization]
  • Change in Dietary Recall [Time frame: 12 months after randomization]
  • Intervention Adherence - lessons viewed [Time frame: 12 months after randomization]
  • Intervention Adherence - self-monitoring [Time frame: 12 months after randomization]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Weight Control & Diabetes Research Center — Providence

Identifiers

NCT: NCT05799846 · 1809657-4 · R01DK128412

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗