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Идёт набор NCT07288294

PRImary Care Strategies for Weight Management (PRISM) Study

Без фазы С лечением Obesity

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: PRISM Program.
Кому может быть актуально
Состояния в реестре: Obesity. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Primary-Care Strategies to Enhance Weight Management (PRISM) After Discontinuation of Anti-Obesity Medications

Обзор

The goal of this clinical trial pilot is to determine the feasibility of an intervention to enhance weight management in patients who have stopped taking anti-obesity/weight management medications in primary care. The main questions it aims to answer are: * Can patients be recruited into the study efficiently? * Is the program acceptable to patients? * Can the study be conducted efficiently? The new program will be compared to usual care.

Подробное описание

The goal of this clinical trial pilot is to determine the feasibility of an intervention to enhance weight management in patients who have stopped taking anti-obesity/weight management medications in primary care. The main questions it aims to answer are:

* Can patients be recruited into the study efficiently? * Is the program acceptable to patients? * Can the study be conducted efficiently?

The new program will be compared to usual care.

Participants will be asked to 1) complete short surveys about their medication use while taking the weight management medication, 2) complete online visits using study-provided scales, and 3) complete video visits with study staff monthly and online check-ins weekly, if assigned to the active treatment group.

Вмешательства

  • Поведенческое PRISM Program
    This is a novel, remotely delivered, self-tailored intervention for post-anti-obesity medication discontinuation weight management. The program incorporates standard-of-care behavioral intervention strategies for weight control to improve routine self-weighing, dietary self-monitoring, and increasing physical activity. The program includes an enhanced focus on strategies to reduce food cue reactivity. The program includes six monthly one-on-one sessions between study staff and participants, asyn

Первичные конечные точки

  • Recruitment rate [Срок оценки: Baseline]
  • Acceptability of the Intervention [Срок оценки: 3 and 6 months post randomization]
Вторичные конечные точки (2)
  • Medication adherence duration questions [Срок оценки: From consent to reported discontinuation, up to 22 months]
  • Reasons for Discontinuation questions [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • For run-in: prescribed liraglutide, semaglutide, or tirzepatide or newer medication approved by the FDA for long-term use for obesity treatment for the purpose of weight managment by a primary care provider at Rush University System for Health and have received at least one dose of the medication concurrent with enrollment in the study.
  • For randomization: discontinue their prescribed anti-obesity medication.
  • Age 18+

Критерии исключения

  • Not fluent in English
  • Diagnosis of diabetes (type 1 or type 2)
  • Current or planned pregnancy
  • Bariatric surgery in the past 2 years or planned bariatric surgery.
  • Body mass index ≥60 kg/m2, due to increased injury risk with exercise
  • Body weight ≥ 375 pounds (scale capacity with a margin for regain)
  • No access to home WIFI or a smartphone with data available
  • Medical contraindications to treatment, including significant cognitive impairment, active substance abuse based on the World Health Organization's ASSIST screener, or serious medical illness (e.g., stage 3 or 4 heart failure, cancer, renal failure, etc.)
  • Concurrent engagement with other behavioral treatments for obesity (for randomized phase only).
  • Medication obtained from online/compound pharmacies or prescription from specialty clinic without a prescription from primary care team at the time of enrollment
  • Another member of the household is enrolled in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Rush University Medical Center — Chicago

Идентификаторы

NCT: NCT07288294 · ORA#24011905

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗