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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity/therapy
• Intervention / Treatment: Behavioral: Automated online weight loss program; Behavioral: Individual coaching; Behavioral: Group-based, videoconference-delivered weight loss

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 Type: Interventional
• Enrollment (Estimated): 490
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica L Unick, PhD; Phone Number: 401-793-8966; Email: junick@brownhealth.org
• Study Contact Backup: Name: Jennifer Webster; Phone Number: 401-793-8946; Email: jwebster@brownhealth.org

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • The Miriam Hospital's Weight Control and Diabetes Research Center
      • Contact: Jessic Unick, PhD; Phone Number: 401-793-8966; Email: junick@brownhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automated online program + coaching; Participants 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.	Behavioral: Automated online weight loss program; 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.; Behavioral: Individual coaching; 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.
Experimental: Automated online program only; Participants randomized to this condition will receive a 12-month automated weight loss program delivered via the Internet.	Behavioral: Automated online weight loss program; 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.
Experimental: Group videoconference program + coaching; Participants 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.	Behavioral: Individual coaching; 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.; Behavioral: Group-based, videoconference-delivered weight loss; 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.
Experimental: Group videoconference program only; Participants randomized to this condition will receive a 12-month, group-based behavioral weight loss program delivered via videoconference.	Behavioral: Group-based, videoconference-delivered weight loss; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost per kilogram of weight loss	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.	12 months
Percent weight change	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).	18 months
Frequency of self-monitoring weight	The number of days that a participant stepped on the scale over the 12-month intervention period will be calculated.	12 months
Self-monitoring of calorie intake	The number of days that a participant reported their calorie intake over the 12-month intervention period will be calculated.	12 months
Change in self-efficacy for diet	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.	12 months
Self-efficacy for exercise	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.	12 months
Change in autonmous motivation	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.	12 months
Change in controlled motivation	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.	12 months

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): April 27, 2028
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: March 8, 2025
• First Submitted That Met QC Criteria: March 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: behavioral weight loss; diet and exercise; remote interventions
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: 2185718

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No