Cognitive Strategies for Weight Loss

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799846
• Other study ID #: 1809657-4
• Secondary ID: R01DK128412
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: March 2023
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: August 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Weight Control & Diabetes Research Center	Providence	Rhode Island

Sponsors (4)

Lead Sponsor	Collaborator
The Miriam Hospital	Brown University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Weight Change at 3 months	Weight change is the primary outcome in this trial and will be calculated as change from baseline.	3 months after randomization
Primary	Percent Weight Change at 6 months	Weight change is the primary outcome in this trial and will be calculated as change from baseline.	6 months after randomization
Primary	Percent Weight Change at 12 months	Weight change is the primary outcome in this trial and will be calculated as change from baseline.	12 months after randomization
Primary	Percent Weight Change Post-Treatment	Post-treatment weight change will be calculated as percent weight change observed at the 18 month assessment (6 months following treatment completion)	18 months after randomization
Secondary	Change in Actigraph-measured Physical Activity (PA)	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).	12 months after randomization
Secondary	Change in Dietary Recall	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.	12 months after randomization
Secondary	Intervention Adherence - lessons viewed	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.	12 months after randomization
Secondary	Intervention Adherence - self-monitoring	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.	12 months after randomization