Comparison of Behaviorally-Based Remote Approaches to Optimize Weight Loss and Identification of Factors Which Characterize Treatment Response

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Body Mass Index between 25-45 kg/m2

• Daily, home Internet access

Locations
United States
Rhode Island
The Miriam Hospital's Weight Control and Diabetes Research Center
RECRUITING
Providence
Contact Information
Primary
Jessica L Unick, PhD
junick@brownhealth.org
401-793-8966
Backup
Jennifer Webster
jwebster@brownhealth.org
401-793-8946
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 490
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: The Miriam Hospital

This content was sourced from clinicaltrials.gov