Confident Moves Intervention Efficacy Trial: Obesity Care Settings

Обзор

The objective of this study is to evaluate the efficacy of the Confident Moves (CM) intervention on device-measured physical activity (PA) and the whole person health index in adults with obesity, compared to standard obesity care alone. Confident Moves (CM) is a web-based physical activity (PA)-promoting research intervention developed by the study team to support adults with obesity. CM is not a medical or clinical treatment; rather, it is designed to promote daily PA through structured, self-paced online learning activities. The intervention has been previously pilot-tested in a feasibility study, which demonstrated its acceptability, safety, and feasibility and informed refinements to study procedures. CM aims to strengthen participants' confidence, knowledge, and behavioral skills related to PA across multiple everyday contexts. The intervention is delivered through a secure, ISU-managed website, with access limited to enrolled participants and authorized research personnel. Only study staff have access to participant data, and data are used solely for research purposes.

Вмешательства

• Поведенческое Confident Moves (CM) Intervention
  Confident Moves (CM) is a web-based physical activity (PA) intervention designed to integrate with obesity care and support daily PA in adults with obesity. A 2025 feasibility trial supported the development of a future randomized controlled trial and identified areas for refinement. Grounded in social cognitive theory, CM targets self-efficacy through structured learning activities such as games, videos, lectures, and self-reflection, incorporating behavior change techniques like goal setting a

Первичные конечные точки

• ActiGraph wGT3X-BT [Срок оценки: At W1 (Week 1-4) and W3 (Week 13-16)]
• Whole Person Health Index (WPHI) scale [Срок оценки: At W1 (Week 1-4) and W3 (Week 13-16)]

Вторичные конечные точки (8)

• Physical Activity Self-Efficacy (PASE) scale [Срок оценки: [Time Frame: At W1 (Week 1-4) and W2 (Week 9)]]
• Self-Efficacy to Regulate Physical Activity (SERPA) scale [Срок оценки: [Time Frame: At W1 (Week 1-4) and W2 (Week 9)]]
• Self-Efficacy for Whole Person Health (SE-WPH) scale [Срок оценки: [Time Frame: At W1 (Week 1-4) and W2 (Week 9)]]
• Self-Efficacy to Engage (SE-E) scale [Срок оценки: [Time Frame: At W2 (Week 9)]]
• Physical Activity Outcome Expectations (PAOE) scale [Срок оценки: [Time Frame: At W1 (Week 1-4), W2 (Week 9), and W3 (Week 13-16)]]
• Subjective Engagement (SE) scale [Срок оценки: [Time Frame: W2 (Week 9)]]
• Support from Obesity Care Centers for Physical Activity (SOCC) scale [Срок оценки: [Time Frame: At W1 (Week 1-4)]]
• International Physical Activity Questionnaire-Short Form (IPAQ-SF) scale [Срок оценки: [Time Frame: At W1 (Week 1-4) and W3 (Week 13-16)]]

Критерии участия

Критерии включения

• Age 18-64 years
• Body Mass Index (BMI) ≥ 25 kg/m²
• Access to a technological device (e.g., computer, smartphone) capable of supporting the online intervention
• Not currently enrolled in another physical activity (PA) intervention (except standard obesity care programs at participating centers)
• Willingness to wear a wrist worn accelerometer for two separate 7 day monitoring periods
• Willingness to respond to study related communications (e.g., email, text, phone call)

Критерии исключения

\- Failure to meet one or more of the inclusion criteria

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07623772 · 26-187

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗