Remote Approaches for Optimizing Weight Loss (Elevate Weight Loss Trial)
Comparison of Behaviorally-Based Remote Approaches to Optimize Weight Loss and Identification of Factors Which Characterize Treatment Response
1 other identifier
interventional
490
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2025
CompletedFirst Submitted
Initial submission to the registry
March 8, 2025
CompletedFirst Posted
Study publicly available on registry
March 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2028
March 18, 2025
March 1, 2025
3.2 years
March 8, 2025
March 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent weight change
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).
12 months
Change in perceived support
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.
12 months
Secondary Outcomes (8)
Cost per kilogram of weight loss
12 months
Percent weight change
18 months
Frequency of self-monitoring weight
12 months
Self-monitoring of calorie intake
12 months
Change in self-efficacy for diet
12 months
- +3 more secondary outcomes
Study Arms (4)
Automated online program + coaching
EXPERIMENTALParticipants randomized to this condition will receive a 12-month automated weight loss program delivered via the Internet plus monthly, individual coaching sessions delivered via videoconference.
Automated online program only
EXPERIMENTALParticipants randomized to this condition will receive a 12-month automated weight loss program delivered via the Internet.
Group videoconference program + coaching
EXPERIMENTALParticipants randomized to this condition will receive a 12-month, group-based behavioral weight loss program delivered via videoconference plus monthly, individual coaching sessions delivered via videoconference.
Group videoconference program only
EXPERIMENTALParticipants randomized to this condition will receive a 12-month, group-based behavioral weight loss program delivered via videoconference.
Interventions
Participants receiving this program are given a daily calorie intake goal of 1200-1800 kcal/day based upon their starting weight and a moderate-intensity aerobic exercise (e.g., walking) goal which progresses to 250 min/week. They are instructed to self-monitor body weight, calorie intake, and exercise minutes daily over 12 months, and are provided with a smart scale for electronic transmission of weight data. Computer-generated, personalized feedback is based upon self-monitoring data, and provided weekly during months 1-3, twice per month during months 4-6, and monthly thereafter. Participants are also instructed to view a new multi-media video lesson weekly during months 1-3, 2x/month during months 4-6, and monthly thereafter (24 lessons in total). These videos are 10-15 minutes in duration and are intended to teach behavioral principles for losing weight, healthy eating, and exercise.
Participants will receive monthly, one-on-one coaching sessions (12 in total) throughout the 12-month intervention period. Coaching sessions will be conducted via videoconference and the initial coaching session will be approximately 30 minutes and all remaining sessions will be approximately 15 minutes. The structure of the coaching sessions will be similar across participants, but the content will be tailored to the individual. Coaches will use goal setting, problem solving, and motivational interviewing to help facilitate adherence and achievement of weight loss program goals.
Participants receiving this program will be instructed to attend interactive group videoconference sessions (60 minutes each) focused on behavioral strategies for changing diet and exercise to promote weight loss. Classes will be weekly during months 1-3, twice per month during months 4-6, and monthly during months 7-12. These classes are designed to allow participants to interact with, support, and learn from one another. Participants are also given a daily calorie intake goal of 1200-1800 kcal/day based upon their starting weight and a moderate-intensity aerobic exercise (e.g., walking) goal which progresses to 250 min/week. They are instructed to self-monitor body weight, calorie intake, and exercise minutes daily over 12 months, and are provided with a smart scale for electronic transmission of weight data. Semi-automated, personalized feedback, based on self-monitoring data, is provided by the group instructor at the same frequency as group sessions are held.
Eligibility Criteria
You may qualify if:
- Body Mass Index between 25-45 kg/m2
- Daily, home Internet access
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Miriam Hospital's Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2025
First Posted
March 13, 2025
Study Start
March 3, 2025
Primary Completion (Estimated)
April 27, 2028
Study Completion (Estimated)
October 31, 2028
Last Updated
March 18, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF