NCT07701460

Brief Summary

Many people who use GLP-1 medications (such as semaglutide or tirzepatide) achieve meaningful weight loss, but maintaining that weight loss off after stopping the medication can be very challenging. Researchers at Tufts University are conducting a study to learn whether a digital lifestyle program can help people maintain their weight loss after they stop taking a GLP-1 medication. Adults who have recently stopped a GLP-1 medication may be eligible to participate. Participants will be randomly assigned to either receive access to a digital program or to continue with usual care. The study lasts 12 months and is fully remote. All participants will receive a Bluetooth scale to track weight from home and will complete short online questionnaires several times over the year. By taking part, participants can help researchers better understand how to support long-term weight maintenance in a way that is affordable, accessible, and sustainable. Participants are compensated for their time, and involvement may help improve care for others with similar experiences.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

July 8, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

ObesityOverweightGlucagon-Like Peptide-1 Receptor AgonistsDigital HealthLifestyle InterventionMobile ApplicationsWeight MaintenanceEating Behavior

Outcome Measures

Primary Outcomes (1)

  • Percentage of weight loss maintained

    Percentage of weight loss maintained over 12 months following GLP-1 medication cessation measured using study-provided Bluetooth scale.

    12-months

Other Outcomes (9)

  • Diet quality

    12-months

  • Food Noise

    12-months

  • PROMIS Global Health

    12-months

  • +6 more other outcomes

Study Arms (2)

Noom® Smart device Application Subscription

EXPERIMENTAL
Behavioral: Digital Behavioral Application

Usual care

NO INTERVENTION

Usual care for weight loss maintenance includes ongoing nutrition, exercise, and lifestyle counseling. However, the implementation of this standard of care is highly variable and dependent on the provider's discretion and availability. In many cases it is nothing. In some cases, the patient may have 1-2 office or remote visits with a provider or dietitian who educates the patient on nutrition and exercise behaviors. "Usual care" is left to each providers' discretion and will identify how much counseling (if any) participants receive through self-report.

Interventions

Noom® provides well-established behavioral strategies for weight loss and weight maintenance, such as self-monitoring of diet, exercise, and weight. What Noom® adds is education on the physiological, psychological, social, and environmental factors that influence eating behavior and tools that increase self-efficacy for dealing with those stimuli. For example, Noom® has a lesson that defines social triggers, explains the influence social triggers have on motivation to eat, and asks the participant to identify their own social triggers and a plan for managing triggers should they come up. Then the app prompts participants to report back on how they managed or struggled to manage a trigger and responds accordingly. Participants will be prescribed 15 minutes of use per day per Noom® recommendations, which includes interactive lessons, food logging, and weigh-ins.

Noom® Smart device Application Subscription

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older (no upper limit);
  • ability to read, write, and speak English and/or Spanish;
  • ability to provide informed consent;
  • less than 30-days since GLP-1 RA cessation;
  • willing to participate.

You may not qualify if:

  • No clinically significant weight loss (e.g., \< 5% body weight) while taking GLP medication;
  • major psychiatric illness, cognitive impairment, or substance misuse that could impair ability to participate;
  • medical conditions that significantly affect weight or make participation unsafe (e.g., pregnancy or breastfeeding, recent bariatric surgery, current use of GLP 1 or other anti-obesity medications, or endocrine disorders that alter weight regulation);
  • inability to use a smartphone or complete remote study procedures;
  • participation in another weight loss or maintenance program or clinical trial judged by investigators to interfere with study involvement;
  • Adults unable to consent (cognitively impaired);
  • Wards of the state;
  • Anyone under age 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

This study is conducted remotely

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

ObesityOverweightFeeding Behavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Kelseanna Hollis-Hansen, PhD, MPH

    Tufts University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

NICHE Lab Study Team

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: This is a 2-arm parallel group open-label randomized controlled trial (RCT) with randomization stratified on 3 factors: (1) prior use of digital behavioral support (Y/N); (2) amount of weight loss (kg) while on GLP-1 (5-10% body weight vs. \>10% body weight); and (3) weight status (with vs without obesity, obesity defined as BMI ≥ 25).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2026

First Posted

July 14, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Sharing of IPD will be at the discretion of the funder.

Locations