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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
The Miriam Hospital
Study ID
NCT06875622
Status
Recruiting
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Conditions

  • Obesity/therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Automated online weight loss program — BEHAVIORAL
    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.
  • Individual coaching — BEHAVIORAL
    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.
  • Group-based, videoconference-delivered weight loss — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Mar 3, 2025
Status verified
Mar 2025
Primary completion
Apr 27, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
490 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Experimental: Automated online program only
    Participants randomized to this condition will receive a 12-month automated weight loss program delivered via the Internet.
  • 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.
  • Experimental: Group videoconference program only
    Participants randomized to this condition will receive a 12-month, group-based behavioral weight loss program delivered via videoconference.

Primary Outcome Measure

Percent weight change [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Miriam Hospital's Weight Control and Diabetes Research CenterProvidenceRhode Island02903
Jessic Unick, PhD
[email protected]
401-793-8966

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By research site
The Miriam Hospital's Weight Control and Diabetes Research Center· Providence, RI

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