Remote Approaches for Optimizing Weight Loss (Elevate Weight Loss Trial)

Not Applicable

Recruiting

• Conditions: Obesity/therapy

• Registration Number: NCT06875622
• Lead Sponsor: The Miriam Hospital

Brief Summary

The purpose of this trial is to compare two delivery formats for weight loss (automated online program vs. group-based videoconference program) and to examine the added effect of individual coaching (vs. no coaching) for individuals with overweight or obesity. All participants enrolled in this study will receive a 12-month behavioral weight loss program (varying in delivery format and individual support), and will be provided with weight loss, calorie intake, and exercise goals. Assessments will occur at baseline, 6 (mid-treatment), 12 (post-treatment), and 18 months (following 6 months of no intervention). We will also seek to determine which combination of intervention approaches works best for whom and develop algorithms which can be used to refer patients into remote programs in clinical settings or future trials.

Detailed Description

Participants will be randomized at baseline to one of four weight loss intervention conditions: 1) automated program + coaching, 2) automated program + no coaching, 3) group videoconference program + coaching, and 4) group videoconference program + no coaching. All participants will be provided with weekly goals, instructed to self-monitor diet, exercise, and weight daily, and provided with feedback based upon these data. Those receiving the online program will also be instructed to view video lessons (24 in total, 10-15 min each) which focus on behavioral strategies for changing diet and exercise. Individuals randomized to the videoconference program will participate in 24 group sessions (1 hour each) designed to mimic in-person treatment and allow for participant interaction via large and small group discussions. The content across conditions will be similar and the lessons will be provided weekly during months 1-3, twice per month during months 4-6, and monthly during months 7-12. Those receiving coaching will have individual, monthly meetings with a coach via videoconference (\~15 min each). Coaching sessions will focus on individual barriers, problem solving, goal setting, and fostering support and accountability.

The primary aim of this study is to examine the effects of delivery format (automated online vs. videoconference) and coaching (individualized vs. none) on weight loss at 12 months. Secondary aims will examine the effects of delivery format and coaching on intervention engagement (e.g., frequency of self-monitoring), psychosocial outcomes (e.g., perceived support, self-efficacy, and motivation), 18-month weight loss, and the cost per kilogram of weight loss (to examine whether the addition of human support is cost-effective). Two algorithms will also be developed to predict which treatment type should be recommended to whom, using only baseline characteristics: 1) a 'widely-applicable' algorithm which will use metrics common to electronic medical records (sex, BMI, age, race, ethnicity), and 2) a 'more comprehensive' algorithm which will further include additional baseline characteristics (e.g., education, household income, health literacy, group preference, etc).

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-03
• Study First Submitted: 2025-03-08
• Study First Submitted QC: 2025-03-08
• Study First Posted: 2025-03-13
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Primary Completion: 2028-04-27
• Study Completion: 2028-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

• Body Mass Index between 25-45 kg/m2
• Daily, home Internet access

Exclusion Criteria

• Currently pregnant, planning to become pregnant within the next 18 months, or pregnant within the past 6 months
• Current or recent enrollment (<2 years) in a weight loss program
• Presence of any medical condition for which exercise, weight loss, or dietary restriction is contraindicated
• Recent weight loss (≥10 pounds within the past 6 months)
• Currently taking weight loss medications or history of bariatric surgery
• Inability to walk 2 blocks without stopping
• Non-English speaking
• A member of one's household is participating in the study
• History of anorexia or bulimia nervosa

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent weight change	12 months	Weight change will be assessed via smart scales using weight at baseline and 12 months and calculated as follows: (\[12-month weight minus baseline weight\] / baseline weight \* 100).
Change in perceived support	12 months	Perceived support will be measured via the Important Others Questionnaire. Scores on this questionnaire range from 12 to 84 with higher scores indicating a greater perception of support from important others. Change in perceived support will be calculated as follows: 12-month perceived support minus baseline perceived support.

Secondary Outcome Measures

Name	Time	Method
Percent weight change	18 months	Weight change will be assessed via smart scales using weight at baseline and 18 months and calculated as follows (\[18 month weight minus baseline weight\] / baseline weight \* 100).
Self-monitoring of calorie intake	12 months	The number of days that a participant reported their calorie intake over the 12-month intervention period will be calculated.
Self-efficacy for exercise	12 months	Self-efficacy for exercise will be measured via the Self-Efficacy for Exercise Scale. Scores range from 0 to 90 with higher scores indicating greater self-efficacy. Change in self-efficacy for exercise will be calculated as the 12-month score minus the baseline score.
Change in autonmous motivation	12 months	Autonomous motivation will be measured via the Treatment Self-Regulation Questionnaire for Weight Management (autonomous motivation subscale). Scores range from 6 to 42 and higher scores indicate more autonomous motivation. Change in motivation will be calculated as the 12-month score minus the baseline score.
Change in controlled motivation	12 months	Controlled motivation will be measured via the Treatment Self-Regulation Questionnaire for Weight Management (controlled motivation subscale). Scores range from 6 to 42 and higher scores indicate more controlled motivation. Change in motivation will be calculated as the 12-month score minus the baseline score.
Cost per kilogram of weight loss	12 months	The cost per participant to deliver the intervention will be calculated and divided by the average weight change (in kilograms) from baseline to 12 months.
Change in self-efficacy for diet	12 months	Self-efficacy for diet will be measured via the Weight Efficacy Lifestyle Questionnaire. Scores range from 0 to 80, with higher scores indicating greater self-efficacy. Change in self-efficacy for diet will be calculated as 12-month score minus the baseline score.
Frequency of self-monitoring weight	12 months	The number of days that a participant stepped on the scale over the 12-month intervention period will be calculated.

Trial Locations

Locations (1)

The Miriam Hospital's Weight Control and Diabetes Research Center; 🇺🇸 Providence, Rhode Island, United States