Cognitive Strategies for Weight Loss

Not Applicable

Recruiting

• Conditions: Obesity

• Registration Number: NCT05799846
• Lead Sponsor: The Miriam Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-28
• Status Verified: 2023-03
• Study Start: 2023-03-01
• Study First Submitted QC: 2023-03-22
• Last Update Submitted: 2023-03-22
• Study First Posted: 2023-04-05
• Last Update Posted: 2023-04-05
• Primary Completion: 2026-05-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent Weight Change at 12 months	12 months after randomization	Weight change is the primary outcome in this trial and will be calculated as change from baseline.
Percent Weight Change at 3 months	3 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 months	6 months after randomization	Weight change is the primary outcome in this trial and will be calculated as change from baseline.
Percent Weight Change Post-Treatment	18 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)

Secondary Outcome Measures

Name	Time	Method
Change in Dietary Recall	12 months after randomization	Diet will be measured through 3, non-consecutive 24-hour diet recalls at baseline, 3m, 12m, and 18m. Recalls will be collected on two weekdays and one weekend at each time point with the first recall collected during the in-person assessment and the subsequent two recalls collected via phone. A trained interviewer will collect recalls using Nutrition Data Systems for Research (NDSR 2018; Nutrition Coordinating Center, University of Minnesota). NDSR uses a multipass method which provides participants multiple opportunities to recall each consumed food/beverage and reduces reporting biases. Given issues with use of dietary recalls to determine absolute energy intake, NDSR output will be used to examine changes in energy density and diet quality, as measured by the Healthy Eating Index, 2015 (HEI-2015). Component scores will highlight changes in intake of fruits and vegetables, whole grains, and lean proteins as well as calories from alcohol, added sugars and energy-dense snacks.
Intervention Adherence - lessons viewed	12 months after randomization	Intervention adherence will be assessed automatically via the study website during the entire 12-month iBWL treatment program. Outcome measures will include number of website number of intervention videos viewed.
Intervention Adherence - self-monitoring	12 months after randomization	Intervention adherence will be assessed automatically via the study website during the entire 12-month iBWL treatment program. Outcome measures will include number of website number of self-monitoring entries during the weight loss program.
Change in Actigraph-measured Physical Activity (PA)	12 months after randomization	To address Secondary Aim 1, physical activity (PA) will be objectively-measured for 1 week at baseline, 3m, 12m, and 18m using ActigraphGT9X Link. Participants will be instructed to wear the accelerometer on their waist during all waking hours, exclusive of bathing and swimming, for 7 consecutive days. This monitor uses a validated triaxial accelerometer and proprietary data filtering technology to estimate free-living PA and sedentary behaviors. Accelerometer data will be processed and analyzed using Actigraph's ActiLife software. Data will be considered valid if the monitor was worn for more than 10 hours on more than 4 days (including one or more weekend day). Intensity will be assessed as average counts per minute (cpm) and previously validated cut points (Freedson et al., 1998) will be used to identify bout-related moderate-to-vigorous intensity PA (greater than or equal to 1952 cpm accumulated in bouts greater than or equal to 10 min) and sedentary time (less than 100 cpm).

Trial Locations

Locations (1)

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