Digital Behavioral Application for Weight Maintenance

(AFTER-GLP Trial)

RS
NL
Overseen ByNICHE Lab Study Team
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Tufts University
Must be taking: GLP-1
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a digital program helps maintain weight loss after stopping GLP-1 medications like semaglutide. Participants will either use a digital lifestyle app (Digital Behavioral Application) or continue their usual care to compare outcomes. The study focuses on adults who have recently stopped GLP-1 medication and experienced significant weight loss. Conducted entirely remotely, the trial lasts 12 months, with participants using a Bluetooth scale and completing online surveys. Participation contributes to identifying affordable and accessible strategies for long-term weight maintenance. As an unphased trial, it offers participants the opportunity to explore innovative, non-drug strategies for maintaining weight loss.

What prior data suggests that this digital lifestyle program is safe for weight maintenance?

Research has shown that the Noom app is generally safe for users, aiding in lasting lifestyle changes through daily lessons and food tracking. Studies indicate that people using Noom for weight management experience few negative effects. Many find the program easy to use and acceptable, with no major safety issues reported.

One study found that Noom users continued to lose weight even a year after finishing the program. This finding suggests that the program not only aids in weight maintenance but is also well-tolerated over time. Overall, Noom appears to be a reliable and safe choice for those looking to maintain weight loss after stopping GLP-1 medications.12345

Why are researchers excited about this trial?

Researchers are excited about the Digital Behavioral Application for weight maintenance because it offers a personalized, tech-driven approach that differs from the usual care options like traditional counseling on nutrition and exercise. Unlike standard methods, which can vary greatly depending on the provider, this application delivers consistent, on-demand support through smart devices, making it more accessible and potentially more engaging for users. The digital platform may also provide real-time feedback and tracking, empowering users to maintain their weight more effectively with the help of data-driven insights.

What evidence suggests that this digital behavioral application is effective for weight maintenance?

Research has shown that digital programs like the Noom app, which participants in this trial may use, can help people maintain weight loss. One study found that people who used Noom lost more weight and maintained their weight loss better than those who didn't use the app. Noom provides personalized coaching, goal-setting, and tracking tools, which support users in maintaining healthy habits. While the results are promising, individual experiences may vary, and regular use of the app might be important for success.

Who Is on the Research Team?

KH

Kelseanna Hollis-Hansen, PhD, MPH

Principal Investigator

Tufts University

Are You a Good Fit for This Trial?

This trial is for adults who have recently stopped taking a GLP-1 medication (like semaglutide or tirzepatide) for weight loss. Participants should be interested in maintaining their weight and able to use digital tools at home.

Inclusion Criteria

Ability to read, write, and speak English and/or Spanish
Willing to participate
Ability to provide informed consent
See 2 more

Exclusion Criteria

I am unable to use a smartphone or complete study tasks remotely.
I am not able to give consent due to cognitive impairment.
I have not lost more than 5% of my body weight while on GLP medication.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to either receive access to a digital program or to continue with usual care for weight loss maintenance

12 months
Fully remote with several online questionnaires

Follow-up

Participants are monitored for weight maintenance and overall wellbeing after stopping GLP-1 medication

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Digital Behavioral Application

Trial Overview

The study tests whether a digital lifestyle program helps people keep off the weight they've lost after stopping GLP-1 medications, compared to usual care. Participants are randomly assigned to either group and track their progress remotely over 12 months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Noom® Smart device Application SubscriptionExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials
271
Recruited
595,000+

Noom Inc.

Industry Sponsor

Trials
17
Recruited
2,800+

Citations

Longitudinal Effects of a Commercial Digital Weight ...

The proposed study seeks to rigorously evaluate and compare the effectiveness of a fully remote digital weight management program (Noom Weight) ...

Noom: Lose weight and keep it off.

Noom Weight is our award-winning weight-loss program designed by psychologists. It focuses on behavioral changes, daily lessons, and food logging to help ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37810531/

Weight loss maintenance after a digital commercial ...

This study provides real-world data on the long-term weight maintenance achieved using a fully digital behavioral program.

What Happens After You Stop a GLP-1? New ...

Modeled Noom data from a sample population show Noom may help maintain weight loss after discontinuation. In two preliminary studies, ...

Publications

Noom Weight was shown to be feasible, acceptable, safe and highly efficacious as the program led to significantly greater body weight loss than standard ...