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Набор скоро начнётся NCT07535892

Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation

Без фазы С лечением Weight Loss GLP - 1 Weight Loss Maintenance Obesity & Overweight

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Weight Loss Maintenance Program (Foundational), Mom's Meals, YMCA Membership, SKY Meditation Program.
Кому может быть актуально
Состояния в реестре: Weight Loss, GLP - 1, Weight Loss Maintenance, Obesity & Overweight. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Pilot Trial of a Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation

Обзор

This study is a single-site, pilot randomized factorial trial designed to evaluate the feasibility, acceptability, participant perceptions and preliminary effects of a multi-component behavioral intervention to support weight loss maintenance following discontinuation of GLP-1 and other anti-obesity medications. The intervention includes a standardized 10-week foundational weight loss maintenance program combined with candidate support components, including medically tailored meals, YMCA membership, and a structured mind-based program. Participants will be randomized using a 2 × 2 × 2 factorial design and followed for six months. Findings from this pilot study will inform optimization of a scalable intervention for future clinical trials.

Вмешательства

  • Поведенческое Weight Loss Maintenance Program (Foundational)
    All participants will receive a standardized 10-week foundational weight loss maintenance program designed to address three key domains: food, physical activity, and mind-based practices. This foundational program is intended to support the transition from active weight loss to long-term weight maintenance.
  • Поведенческое Mom's Meals
    Medically tailored meals
  • Поведенческое YMCA Membership
    YMCA membership to support physical activity
  • Поведенческое SKY Meditation Program
    The SKY Meditation program to support mind-based practices

Первичные конечные точки

  • Percentage of participants retention [Срок оценки: 3 months, 6 months,]
  • Percentage of participants that adhered to the 10-week foundational support sessions [Срок оценки: 10 weeks]
Вторичные конечные точки (1)
  • Overall Weight Loss Maintenance without medication [Срок оценки: Baseline, 3 months, 6 moths]

Критерии участия

Критерии включения

  • Age 18 years or older
  • Loss of ≥15% of initial body weight using anti-obesity medication
  • Discontinued anti-obesity medication within the past 4 weeks or planning to discontinue prior to randomization
  • ≤3 kg weight regain within the past 3 months
  • Willing and able to participate in a 6-month behavioral intervention, including a 10-week foundational program
  • Willing to complete study assessments at baseline, 3 months, and 6 months, including required in-person visits
  • Medical clearance for participation in moderate physical activity, dietary modification, and mind-based practices
  • Access to reliable internet for participation in virtual sessions and remote data collection
  • English fluency sufficient to complete study procedures
  • Able to provide informed consent

Критерии исключения

  • Medical conditions that would preclude safe participation in physical activity, dietary changes, or mind-based practices (e.g., unstable cardiovascular disease, uncontrolled hypertension, severe orthopedic limitations, or seizure disorders not medically managed)
  • Active psychiatric conditions that would interfere with participation or safety (e.g., untreated major depression, active substance use disorder, or psychosis)
  • Pregnancy, breastfeeding, or plans to become pregnant during the study period
  • Current participation in another structured weight loss or weight maintenance program
  • Continued use of anti-obesity medication after randomization
  • Plans to initiate medications or treatments that may significantly affect body weight during the study period
  • Inability to attend required study visits or participate in virtual sessions and remote data collection
  • Any condition that, in the opinion of the investigators, would compromise participant safety or study integrity

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of Alabama at Birmingham — Birmingham

Идентификаторы

NCT: NCT07535892 · IRB-300016552 · 1R01DK147319-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗