Recruiting

Weight Loss

Sponsor:

The Miriam Hospital

Code:

NCT06875622

Conditions

Obesity/therapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Automated online weight loss program

Individual coaching

Group-based, videoconference-delivered weight loss

Study Details

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.

Conditions

Obesity/therapy

Study ID

NCT06875622

Start date

Mar 3, 2025

Status verified date

Mar, 2025

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Apr 27, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

490 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

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.

Primary outcome measure

  • Percent weight change [ Time Frame: 12 months ]
  • Change in perceived support [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

The Miriam Hospital's Weight Control and Diabetes Research Center

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

More Information

Sponsor

The Miriam Hospital

Last update posted

Mar 18, 2025

Last verified

Mar, 2025

Keywords

  • behavioral weight loss
  • remote interventions
  • diet and exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2025-03-18.