Confident Moves Intervention Efficacy Trial: Obesity Care Settings

NCT07623772 | Not Yet Recruiting

• 1 other identifier: 26-187
• Study Type: interventional
• Target: 348
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity; Overweight

Keywords

eHealth; Internet applications; information and communication technologies; exercise

Outcome Measures

Primary Outcomes (2)

• ActiGraph wGT3X-BT

  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.

  At W1 (Week 1-4) and W3 (Week 13-16)

• Whole Person Health Index (WPHI) scale

  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.

  At W1 (Week 1-4) and W3 (Week 13-16)

Secondary Outcomes (8)

• Physical Activity Self-Efficacy (PASE) scale

  [Time Frame: At W1 (Week 1-4) and W2 (Week 9)]

• Self-Efficacy to Regulate Physical Activity (SERPA) scale

  [Time Frame: At W1 (Week 1-4) and W2 (Week 9)]

• Self-Efficacy for Whole Person Health (SE-WPH) scale

  [Time Frame: At W1 (Week 1-4) and W2 (Week 9)]

• Self-Efficacy to Engage (SE-E) scale

  [Time Frame: At W2 (Week 9)]

• Physical Activity Outcome Expectations (PAOE) scale

  [Time Frame: At W1 (Week 1-4), W2 (Week 9), and W3 (Week 13-16)]

Study Arms (2)

Standard Care Group

NO INTERVENTION

Participants assigned to the standard care group will receive only the obesity centers' standard obesity care program during the data collection period. They will be provided with login credentials to access the CM website for data collection at wave 1 (W1), wave 2 (W2), and wave 3 (W3).

CM Group

EXPERIMENTAL

Participants assigned to the Confident Moves (CM) group also will receive the obesity centers' program and will be provided with 4 weeks of continuous (24-hour) access to the CM intervention during the data collection period. Access to the CM intervention will become available between W1 and W2, and those in this group will be notified via email. They will be encouraged to actively engage with the intervention, including completing at least 26 intervention challenges. They will be provided with login credentials to access the CM website for both the CM intervention and data collection at W1, W2, and W3.

Behavioral: Confident Moves (CM) Intervention

Interventions

Confident Moves (CM) Intervention BEHAVIORAL

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.

Also known as: Physical Activity Self-efficacy (PAS) Intervention

CM Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

Sponsors & Collaborators

• Iowa State University: lead
• Michigan State University: collaborator

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Seungmin Lee, PhD

CONTACT

515-294-8257; seunglee@iastate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share