Confident Moves Intervention Efficacy Trial: Obesity Care Settings

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorIowa State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

348 Participants
are divided into 2 treatment groups
Group A: Standard Care GroupNo intervention 0 interventions
Group B: CM GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At W1 (Week 1-4) and W3 (Week 13-16)
2

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.

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

Secondary outcomes

1

Physical Activity Self-Efficacy (PASE) scale

Physical Activity Self-Efficacy (PASE) will be assessed at W1 and W2 using a 36-item self-reported scale measuring confidence in achieving recommended weekly physical activity (PA). PASE evaluates self-efficacy across four domains: occupational, transport, domestic, and leisure PA. Occupational and leisure domains include moderate- and vigorous-intensity activities, whereas transport and domestic domains include moderate-intensity activities only. Items are rated on a 5-point scale (0 = no confidence to 4 = complete confidence), consistent with standard self-efficacy measures. Total scores range from 0 to 144, with higher scores indicating greater PA self-efficacy.

Time frame
[Time Frame: At W1 (Week 1-4) and W2 (Week 9)]
2

Self-Efficacy to Regulate Physical Activity (SERPA) scale

Self-efficacy to regulate physical activity (SERPA) will be measured at W1 and W2 using a 13-item version of the SERPA scale. This scale will assess participants' confidence in their ability to overcome barriers to sustaining weekly PA. Previous measurement studies of the SERPA scale indicate a two-factor structure reflecting different types of barriers to PA. Items are rated on a five-point self-efficacy scale (0 = no confidence to 4 = complete confidence). Total scores range from 0 to 52, with higher scores indicating better outcomes.

Time frame
[Time Frame: At W1 (Week 1-4) and W2 (Week 9)]
3

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

Self-Efficacy for Whole Person Health (SE-WPH) will be measured at W1 and W2 using a newly developed 9-item self-reported scale. The SE-WPH assesses confidence in engaging in and sustaining behaviors that support whole person health across physical, psychological, and social domains, aligned with the Whole Person Health Index (WPHI). Items reflect key areas including overall health and quality of life, social connections, health behaviors (diet, physical activity, sleep, stress), and health self-management. Items are rated on a 5-point scale (0 = no confidence to 4 = complete confidence). Psychometric evaluation (reliability and validity) will be conducted prior to hypothesis testing. Total scores range from 0 to 36, with higher scores indicating greater self-efficacy.

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

Self-Efficacy to Engage (SE-E) scale

Self-Efficacy to Engage (SE-E) will be measured at W2 among participants in the CM group upon access to the intervention, using a previously developed 7-item self-reported scale. The SE-E assesses confidence in engaging with the online intervention and is conceptually aligned with subjective engagement. An example item is: "How confident are you in your current ability to pay close attention when engaging with this online intervention?" Items are rated on a 5-point scale (0 = no confidence to 4 = complete confidence). Although previously developed, the scale was only used in a feasibility trial; thus, reliability and validity will be evaluated prior to hypothesis testing. Total scores range from 0 to 28, with higher scores indicating greater engagement self-efficacy.

Time frame
[Time Frame: At W2 (Week 9)]

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Iowa State University

Lead sponsor

Michigan State University

Collaborator

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