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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Riti Sarangi, MPH
- Número de telefone: (617) 636-0832
- E-mail: Ritimukta.Sarangi@tufts.edu
Estude backup de contato
- Nome: NICHE Lab Study Team
- Número de telefone: (469) 240-9112
- E-mail: niche@tufts.edu
Locais de estudo
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02111
- This study is conducted remotely
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
|
Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of weight loss maintained
Prazo: 12-months
|
Percentage of weight loss maintained over 12 months following GLP-1 medication cessation measured using study-provided Bluetooth scale.
|
12-months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Diet quality
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kelseanna Hollis-Hansen, PhD, MPH, Tufts University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00007074
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .