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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the most effective method for delivering remote weight loss programs to individuals with overweight or obesity. Participants will engage in either an automated online weight loss program or a group-based, videoconference-delivered program, with some also receiving individual coaching. The study seeks to determine the most effective combination, potentially guiding future recommendations for remote weight loss programs. Ideal participants have a Body Mass Index (BMI) between 25 and 45, access to the Internet, and are not currently enrolled in another weight loss program. As an unphased trial, this study offers participants the chance to contribute to innovative research that could shape future weight loss solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking weight loss medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both the automated online weight loss program and the group-based videoconference program are safe and well-received by participants.

For the automated online weight loss program, studies have found that digital or online programs are generally as effective and safe as in-person ones. Participants in these studies reported no major safety issues, indicating that the program is easy to use and well-accepted.

Similarly, the group-based videoconference weight loss program has proven effective and acceptable to participants. Research shows that people can lose a significant amount of weight without major problems, meaning most participants manage the program well.

Both types of programs are delivered remotely, which research has shown to be a safe and effective way to support weight loss without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for weight loss because they offer flexible, remote options that could make it easier for people to access effective weight management programs. Unlike traditional in-person weight loss programs, these treatments are delivered entirely online or via videoconference, allowing participants to engage from anywhere. One arm features an automated online program combined with individual coaching, which provides personalized support without needing face-to-face meetings. Another option offers a group-based program through videoconference, fostering community and accountability remotely. By leveraging technology, these methods aim to reach a broader audience and adapt to diverse lifestyles, potentially making weight loss more attainable for many.

What evidence suggests that this trial's treatments could be effective for weight loss?

Research has shown that online health programs, such as automated weight loss websites, can help people lose weight effectively, similar to in-person programs. Studies indicate that these digital programs can significantly enhance weight loss results. In this trial, participants may receive an automated online weight loss program, either alone or with individual coaching.

Research has found that group weight loss programs conducted via video calls have a strong impact on weight loss. These programs can be as effective as in-person meetings and offer a flexible, scalable option for managing weight. Participants in this trial may receive a group-based videoconference program, either alone or with additional individual coaching. Both methods in this trial have shown promising results in aiding weight loss. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10482795/

The Effectiveness of eHealth Interventions for Weight Loss ... The review indicates that eHealth interventions are more effective than control interventions or no care and comparable to face-to-face interventions.

2. jmir.org jmir.org/2025/1/e69466

Impact of Digital Engagement on Weight Loss Outcomes in ... Engagement with a digital weight management platform significantly enhances weight loss outcomes among individuals using GLP-1 receptor agonists.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2451865420301228

Effectiveness of a web-based real-life weight management ... Healthy Weight Coaching (HWC) is a 12-month web-based intervention for the management of obesity. The program is based on the Acceptance and Commitment Therapy.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2819706

An Adaptive Telephone Coaching Intervention for Patients ... This randomized clinical trial compares brief and extended coaching programs for patients in an online weight loss program who had achieved less

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/20552076251314090

The use of an automatic remote weight management ... The objective of this pilot study is to evaluate the feasibility of using an automatic weight management system to follow patients' response to weight ...

6. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.70244

Digital engagement enhances dual GIP/GLP‐1 receptor ... We evaluated the weight loss efficacy and safety of a national digital weight loss service (DWLS) and explored associations between digital ...

7. nature.com nature.com/articles/s41591-024-03384-x

the randomized wait-list-controlled ReDIRECT trial We found that a remotely delivered weight management intervention in people with LC and excess body weight effectively reduced LC symptoms that ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9912959/

A Cluster Randomized Controlled Trial of Automated ... This study aims to compare referral to a comprehensive automated digital weight loss program, with or without provider email feedback, to usual care, on weight ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05015491

Effects of Online App Weight Loss Programs on Liver ... There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...