Clinical trial
Confident Moves Intervention Efficacy Trial: Obesity Care Settings
Opening soon · Not applicable · 0 countries · Registry ID NCT07623772
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
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 and action planning. The online program includes seven components addressing multiple PA domains and mindfulness, delivered over 4 weeks with flexible access.
Primary outcomes
Device-measured physical activity (PA) will be assessed at W1 and W3 using the ActiGraph wGT3X-BT (Pensacola, FL, USA), a tri-axial research-grade accelerometer. Devices will collect data at 30 Hz and be reintegrated into 60-s epochs. Non-wear will be defined as ≥90 consecutive minutes of zero counts, allowing ≤2 min of nonzero counts if surrounded by ≥30 min of zeros. Data will be considered valid if participants have ≥3 days with ≥10 h/day of wear, no device malfunction, and consistency with logs. Moderate-to-vigorous PA (MVPA) will be defined as ≥3,941 counts/min using wrist-specific vector magnitude cut-points validated in free-living adults.
The Whole Person Health Index (WPHI) will be measured at W1 and W3 using a 9-item self-reported scale developed by the National Center for Complementary and Integrative Health, in collaboration with the Centers for Disease Control and Prevention. The WPHI assesses overall health across physical, psychological, and social domains, reflecting a whole person health framework beyond disease-specific outcomes. Items assess general health, quality of life, social/family connections, diet, physical activity, stress management, sleep, meaning/purpose, and ability to manage health, rated on a 5-point Likert scale (1=poor to 5=excellent). The WPHI is validated and used in observational and clinical studies, including the 2025 National Health Interview Survey. Total scores range from 9 to 45, with higher scores indicating better health outcomes.
Study locations
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