Clinical trial NCT06875622: Remote Approaches for Optimizing Weight Loss (Elevate Weight Loss Trial)
Official title: Comparison of Behaviorally-Based Remote Approaches to Optimize Weight Loss and Identification of Factors Which Characterize Treatment Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity/therapy
Keywords: behavioral weight loss
remote interventions
diet and exercise
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-03-13
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Percent weight change
timeFrame: 12 months
measure: Change in perceived support
timeFrame: 12 months
Secondary outcomes:
measure: Cost per kilogram of weight loss
timeFrame: 12 months
measure: Percent weight change
timeFrame: 18 months
measure: Frequency of self-monitoring weight
timeFrame: 12 months
measure: Self-monitoring of calorie intake
timeFrame: 12 months
measure: Change in self-efficacy for diet
timeFrame: 12 months
measure: Self-efficacy for exercise
timeFrame: 12 months
measure: Change in autonmous motivation
timeFrame: 12 months
measure: Change in controlled motivation
timeFrame: 12 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital's Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
References: