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

N/ANot Yet RecruitingNCT07701460

Tufts University200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

200

Conditions

Weight Maintenance

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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; * willing to participate. Exclusion Criteria: * 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.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts