Clinical trial NCT05799846: Cognitive Strategies for Weight Loss
Official title: Adapting Episodic Future Thinking for Behavioral Weight Loss: Comparing Strategies and Characterizing Treatment Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Brown University
name: University of Minnesota
First posted: 2023-04-05
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Percent Weight Change at 3 months
timeFrame: 3 months after randomization
measure: Percent Weight Change at 6 months
timeFrame: 6 months after randomization
measure: Percent Weight Change at 12 months
timeFrame: 12 months after randomization
measure: Percent Weight Change Post-Treatment
timeFrame: 18 months after randomization
Secondary outcomes:
measure: Change in Actigraph-measured Physical Activity (PA)
timeFrame: 12 months after randomization
measure: Change in Dietary Recall
timeFrame: 12 months after randomization
measure: Intervention Adherence - lessons viewed
timeFrame: 12 months after randomization
measure: Intervention Adherence - self-monitoring
timeFrame: 12 months after randomization
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control & Diabetes Research Center
state: Rhode Island
Study officials:
References: