Assessing Follow up Trajectories in Eating, Routines, and Weight After GLP-1 (AFTER-GLP)
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Riti Sarangi, MPH
- Telefonszám: (617) 636-0832
- E-mail: Ritimukta.Sarangi@tufts.edu
Tanulmányozza a kapcsolattartók biztonsági mentését
- Név: NICHE Lab Study Team
- Telefonszám: (469) 240-9112
- E-mail: niche@tufts.edu
Tanulmányi helyek
-
-
Massachusetts
-
Boston, Massachusetts, Egyesült Államok, 02111
- This study is conducted remotely
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Tényező hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Noom® Smart device Application Subscription
|
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.
|
|
Nincs beavatkozás: 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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Percentage of weight loss maintained
Időkeret: 12-months
|
Percentage of weight loss maintained over 12 months following GLP-1 medication cessation measured using study-provided Bluetooth scale.
|
12-months
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Diet quality
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Kelseanna Hollis-Hansen, PhD, MPH, Tufts University
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- STUDY00007074
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .