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Not yet recruiting NCT07623772

Confident Moves Intervention Efficacy Trial: Obesity Care Settings

No phase Interventional Obesity Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Confident Moves (CM) Intervention.
Who it may be relevant to
Registry conditions: Obesity, Overweight. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral 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

Primary outcome measures

  • ActiGraph wGT3X-BT [Time frame: At W1 (Week 1-4) and W3 (Week 13-16)]
  • Whole Person Health Index (WPHI) scale [Time frame: At W1 (Week 1-4) and W3 (Week 13-16)]
Secondary outcome measures (8)
  • Physical Activity Self-Efficacy (PASE) scale [Time frame: [Time Frame: At W1 (Week 1-4) and W2 (Week 9)]]
  • Self-Efficacy to Regulate Physical Activity (SERPA) scale [Time frame: [Time Frame: At W1 (Week 1-4) and W2 (Week 9)]]
  • Self-Efficacy for Whole Person Health (SE-WPH) scale [Time frame: [Time Frame: At W1 (Week 1-4) and W2 (Week 9)]]
  • Self-Efficacy to Engage (SE-E) scale [Time frame: [Time Frame: At W2 (Week 9)]]
  • Physical Activity Outcome Expectations (PAOE) scale [Time frame: [Time Frame: At W1 (Week 1-4), W2 (Week 9), and W3 (Week 13-16)]]
  • Subjective Engagement (SE) scale [Time frame: [Time Frame: W2 (Week 9)]]
  • Support from Obesity Care Centers for Physical Activity (SOCC) scale [Time frame: [Time Frame: At W1 (Week 1-4)]]
  • International Physical Activity Questionnaire-Short Form (IPAQ-SF) scale [Time frame: [Time Frame: At W1 (Week 1-4) and W3 (Week 13-16)]]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07623772 · 26-187

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗