Remote Approaches for Weight Loss

Overseen By Jessica L Unick, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Miriam Hospital

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Recent weight loss, Anorexia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 months

490 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for individuals with overweight or obesity who are interested in losing weight. Participants will engage in a 12-month behavioral weight loss program, which may be delivered as an automated online program or through group-based videoconferences. Some participants will also receive additional individual coaching.

Inclusion Criteria

Body Mass Index between 25-45 kg/m2

Daily, home Internet access

Exclusion Criteria

I am currently on weight loss medication or have had bariatric surgery.

Non-English speaking

I can't walk 2 blocks without stopping.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-month behavioral weight loss program with varying delivery formats and individual support

12 months

Weekly sessions during months 1-3, bi-monthly during months 4-6, monthly during months 7-12

Mid-treatment Assessment

Assessment of weight loss and other metrics at the 6-month mark

1 week

1 visit (virtual)

Follow-up

Participants are monitored for weight loss and other outcomes after the treatment period

6 months

1 visit (virtual) at 18 months

Treatment Details

Interventions

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

Trial Overview The Elevate Weight Loss Trial is testing the effectiveness of two different remote weight loss programs: one that's automated and online, and another that's group-based via videoconference. It also examines whether adding individual coaching improves outcomes compared to no coaching.

Participant Groups

Group I: Group videoconference program only Experimental Treatment 1 Intervention

Participants randomized to this condition will receive a 12-month, group-based behavioral weight loss program delivered via videoconference.

Group II: Group videoconference program + coaching Experimental Treatment 2 Interventions

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.

Group III: Automated online program only Experimental Treatment 1 Intervention

Participants randomized to this condition will receive a 12-month automated weight loss program delivered via the Internet.

Group IV: Automated online program + coaching Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+