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Assessing Follow up Trajectories in Eating, Routines, and Weight After GLP-1

ConditionWeight Maintenance
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTufts University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 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;

Disqualifiers

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;

Trial design

Design model

Factorial

Treatments tested in this trial

  • Digital Behavioral Application

    Behavioral

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Noom® Smart device Application SubscriptionExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

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.

Time frame
12-months

Secondary outcomes

Other outcomes

1

Diet quality

III (Diet History Questionnaire III): Self-report of eating behaviors in questionnaire: 135 food and beverage items Scores are used to calculate HEI-2015: Scale: 0-100 Higher scores indicate better diet quality and improved compliance with federal health and nutrition recommendations https://epi.grants.cancer.gov/dhq3/

Time frame
12-months
2

Food Noise

Self-report of Food Noise questionnaire Scoring note: Total score = sum of 5 items (0-20); higher = more food noise. Attribution to include on the instrument (recommended): Food Noise Questionnaire (FNQ). Diktas HE et al. (2025).

Time frame
12-months
3

PROMIS Global Health

Self-report of 16-item PROMIS Global Health questionnaire; assesses physical, mental, and social health using standardized T-scores Higher scores mean more of what is measured Source: HealthMeasures - PROMIS Health Organization Lowest value: 20 Highest: 80

Time frame
12-months
4

Treatment satisfaction questionnaire

Self-report adaptation of the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM), adapted to a digital behavioral application context Bharmal, M., Payne, K., Atkinson, M. J., Desrosiers, M. P., Morisky, D. E., \& Gemmen, E. (2009). Validation of an abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among patients on antihypertensive medications. Health and Quality of Life Outcomes, 7(36). Range: 0 to 100 Higher Scores = Higher Satisfaction

Time frame
12-months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tufts University

Lead sponsor

Noom Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: