Weight Maintenance
Conditions
Keywords
Obesity, Overweight, Glucagon-Like Peptide-1 Receptor Agonists, Digital Health, Lifestyle Intervention, Mobile Applications, Weight Maintenance, Eating Behavior
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.
Interventions
BEHAVIORALDigital Behavioral Application
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.
Sponsors
Tufts University
Noom Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of weight loss maintained | 12-months | Percentage of weight loss maintained over 12 months following GLP-1 medication cessation measured using study-provided Bluetooth scale. |
Countries
United States
Contacts
CONTACTRiti Sarangi, MPH
CONTACTNICHE Lab Study Team
PRINCIPAL_INVESTIGATORKelseanna Hollis-Hansen, PhD, MPH
Tufts University
Outcome results
None listed