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Идёт набор NCT06994923

Weight Management Intervention in College: A Pilot

Без фазы С лечением Obesity and 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: BWLI-College, Control.
Кому может быть актуально
Состояния в реестре: Obesity and Overweight. Базовые параметры: 18 лет — 29 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

Testing a Behavioral Weight Loss Intervention for Emerging Adults Implemented Within College Health Service Centers

Обзор

This pilot randomized controlled trial will examine a behavioral weight loss intervention that uses a "small change" approach fro emerging adult college students with overweight/obesity. The primary aim is to assess student acceptability and clinically-meaningful weight changes.

Подробное описание

Forty percent of emerging adults (age 18-25) have overweight or obesity, which is unlikely to remit and has significant health consequences. However, emerging adults are underrepresented in traditional weight loss programs, drop-out at high rates, and have blunted weight loss outcomes. One potential way to improve participation is to offer BWLIs in college health service centers to reduce barriers to participation. Approximately 40% of emerging adults are enrolled in a postsecondary institution and college health centers are used widely by students. Moreover, delivering an intervention with design features that are responsive to emerging adult preferences and lifestyles may also improve intervention effectiveness and attractiveness. The "small change" (SC) approach to weight loss addresses emerging adult barriers to engagement by focusing on reducing calories through a few self-selected, specific changes to current obesogenic behaviors, requiring less time and effort than traditional behavioral weight loss interventions (BWLI) and promoting autonomy and self-efficacy. The SC approach has been used effectively for weight loss in other populations. This randomized controlled pilot study is part of a larger study that aims to develop and refine a novel and effective BWLI based on a SC approach that is designed for emerging adults and for implementation in college health centers, an accessible care setting. The primary aim of this substudy is to assess acceptability and feasibility of the intervention and to get a preliminary understanding of potential clinical benefit for participants.

Вмешательства

  • Поведенческое BWLI-College
    Behavioral modifications are based on empirically-supported principles for weight loss. Diet recommendations follow a small change approach in which participants will make a series of small, self-selected dietary changes each day (\~100-200 calories) that they build on over the course of the intervention. Physical activity recommendations are to achieve 150-250 weekly minutes of moderate-to-vigorous physical activity with specific goals and rate of progression that are individualized to each par
  • Поведенческое Control
    Psychoeducation around dieting myths, healthy eating, and physical activity

Первичные конечные точки

  • Acceptability [Срок оценки: 10 weeks]
  • Retention [Срок оценки: 10 weeks]
  • Adherence [Срок оценки: 10 weeks]
  • Weight Loss [Срок оценки: 10 weeks]

Критерии участия

Критерии включения

  • BMI of 25 or greater
  • Enrolled at college/university where study will take place
  • English-speaking

Критерии исключения

  • History or current diagnosis of anorexia nervosa, bulimia nervosa, or alcohol use disorder (current symptoms also assessed at screening using validated screening questionnaires)
  • Participation in another formal weight loss program or current utilization of obesity medications
  • Current or recent pregnancy
  • Psychiatric hospitalization in the past 12 months
  • Recent weight loss of 5% body weight or more
  • History of bariatric surgery
  • Severe food or physical activity restrictions that would interfere with treatment recommendations

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
  • The Miriam Hospital — Providence

Идентификаторы

NCT: NCT06994923 · 17937323 · K23DK128561

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗