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

14. juli 2026 opdateret af: Tufts University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: NICHE Lab Study Team
  • Telefonnummer: ‪(469) 240-9112‬
  • E-mail: niche@tufts.edu

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • This study is conducted remotely

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Noom® Smart device Application Subscription
Adfærdsmæssigt: Digital 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.
Ingen indgriben: Usual care
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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Diet quality
Tidsramme: 12-months
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/
12-months
Food Noise
Tidsramme: 12-months
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).
12-months
PROMIS Global Health
Tidsramme: 12-months
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
12-months
Treatment satisfaction questionnaire
Tidsramme: 12-months

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
12-months
Healthy Eating and Weight Self Efficacy
Tidsramme: 12-months
Self-report of Healthy Eating and Weight Self Efficacy Scale (HEWSE) 11 items: Higher scores indicate higher self-efficacy Lindsay Wilson-Barlow, Tishanna R. Hollins, James R. Clopton, Construction and validation of the healthy eating and weight self-efficacy (HEWSE) scale, Eating Behaviors, Volume 15, Issue 3, 2014, Pages 490-492, ISSN 1471-0153, https://doi.org/10.1016/j.eatbeh.2014.06.004.
12-months
Mindful Eating
Tidsramme: 12-months
Self-report of Mindful Eating Scale in questionnaire Marion van Beekum, Rebecca Shankland, Angélique Rodhain, Margaux Robert, Camille Marchand, et al.. Development and validation of the mindful eating scale (mind-eat scale) in a general population. Appetite, 2024, 199, pp.107398. ⟨10.1016/j.appet.2024.107398⟩. ⟨hal-04582024⟩ 4- or 5-point Likert scale: Higher overall score indicate healthier, more conscious relationship with food
12-months
Overall wellbeing
Tidsramme: 12-months
Self-report of PERMA Profiler in questionnaire Butler, J., & Kern, M.L. (2016). The PERMA-Profiler: A brief multidimensional measure of flourishing. International Journal of Wellbeing, 6(3), 1-48. doi:10.5502/ijw.v6i3.1 23 questions: 11-point Likert scale (0 to 10) Higher the score, the higher the functioning in positive pillars, in negative dimensions lower score indicate better state (reverse-scored)
12-months
Tobacco, alcohol, prescription medications, and other substance use
Tidsramme: 12-months

Self-report of Tobacco, alcohol, prescription medications, and other substance use (TAPS-2) in questionnaire McNeely, J., Wu, L. T., Subramaniam, G., Sharma, G., Cathers, L. A., Svikis, D., & Schwartz, R. P. (2016). Performance of the tobacco, alcohol, prescription medication, and other substance use (TAPS) tool for substance use screening in primary care patients. Annals of Internal Medicine, 165(10), 690-699.

Scoring: 0 (No use), 1 (problem use) and 2 or more higher risk https://nida.nih.gov/taps2/
12-months
Sexual Wellbeing
Tidsramme: 12-months
Self-report on the 5-item Short Sexual Wellbeing scale in questionnaire Gerymski R. Short Sexual Well-Being Scale - a cross-sectional validation among transgender and cisgender people. Health Psychol Rep. 2020;9(3):276-287. Published 2020 Dec 31. doi:10.5114/hpr.2021.102349 Scale: 1-7 points per question Range: 7-49 Higher score means higher level of sexual wellbeing
12-months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tufts University

Samarbejdspartnere

Noom Inc.

Efterforskere

  • Ledende efterforsker: Kelseanna Hollis-Hansen, PhD, MPH, Tufts University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

31. januar 2028

Studieafslutning (Anslået)

31. juli 2028

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00007074

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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