ObesityNCT07623772
Confident Moves Intervention Efficacy Trial: Obesity Care Settings
A study testing Confident Moves (CM) Intervention in people with Obesity and Overweight, run by Iowa State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Confident Moves (CM) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Failure to meet one or more of the inclusion criteria
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Confident Moves (CM) Intervention
- Keywords
- eHealth, Internet applications, information and communication technologies, exercise
- Medical subject headings
- Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Confident Moves (CM) InterventionBehavioural
Also called Physical Activity Self-efficacy (PAS) 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Confident Moves (CM) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At W1 (Week 1-4) and W3 (Week 13-16)
Secondary outcomes (8)
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.
Measured: [Time Frame: At W1 (Week 1-4) and W2 (Week 9)]
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.
Measured: [Time Frame: At W1 (Week 1-4) and W2 (Week 9)]
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.
Measured: [Time Frame: At W1 (Week 1-4) and W2 (Week 9)]
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.
Measured: [Time Frame: At W2 (Week 9)]
Physical Activity Outcome Expectations (PAOE) scale
Physical Activity Outcome Expectations (PAOE) will be assessed at W1, W2, and W3 using a modified 13-item self-reported scale capturing beliefs about expected outcomes of physical activity (PA). The scale was adapted from the Multidimensional Outcome Expectations for Exercise scale, grounded in social cognitive theory and encompassing physical, social, and self-evaluative domains. Modifications were informed by responses from 30 adults with obesity in a 2025 feasibility trial, using inductive analyses and independent item review to enhance relevance to obesity-specific PA contexts. An example item is: "Physical activity will improve my stamina for daily activities." Items are rated on a 5-point scale (1 = strongly disagree to 5 = strongly agree). Psychometric evaluation will be conducted prior to hypothesis testing. Total scores range from 13 to 65, with higher scores indicating more positive outcome expectations.
Measured: [Time Frame: At W1 (Week 1-4), W2 (Week 9), and W3 (Week 13-16)]
Subjective Engagement (SE) scale
Subjective engagement (SE) will be assessed among participants assigned to the CM group after intervention access is provided, using a newly developed subjective engagement scale. This 7-item measure is designed to assess participants' subjective engagement with the web-based intervention, consistent with conceptualizations of engagement in the online behavioral intervention literature. An example item is: "I paid close attention when engaging with this online intervention." Responses will be recorded using a five-point Likert scale (i.e., 0 = not at all to 4 = completely). Because the engagement scale is newly developed, evidence regarding the validity and reliability of scores derived from this measure will be evaluated using data collected at W1.
Total scores range from 0 to 28, with higher scores indicating better outcomes.
Measured: [Time Frame: W2 (Week 9)]
Support from Obesity Care Centers for Physical Activity (SOCC) scale
Support from Obesity Care Centers (SOCC) will be assessed at W1 using a 7-item self-reported scale informed by the 2025 CM feasibility trial. The SOCC assesses experiences with and perceptions of physical activity (PA)-related support received outside the CM intervention. It includes a screening item on receipt of PA support, followed by conditional items assessing type of support and satisfaction. Participants reporting support describe it in open-ended form and rate satisfaction on a 5-point scale (1 = very dissatisfied to 5 = very satisfied). Additional items assess referrals to PA resources and perceived preferences, needs, and barriers. Data will be used descriptively to contextualize PA support and inform intervention refinement. Total scores range from 7 to 35, with higher scores indicating greater perceived support.
Measured: [Time Frame: At W1 (Week 1-4)]
International Physical Activity Questionnaire-Short Form (IPAQ-SF) scale
Self-reported PA will be measured at W1, W2, and W3 with the short form of International Physical Activity Questionnaire (IPAQ). This questionnaire assesses the frequency and duration of walking, moderate-, and vigorous-intensity PA over the past 7 days. Average minutes per day of moderate-to-vigorous physical activity (MVPA) will be calculated based on the IPAQ guidelines.
Measured: [Time Frame: At W1 (Week 1-4) and W3 (Week 13-16)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University
- Responsible party
- Principal investigator, Seungmin Lee, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623772
- Sponsor's protocol ID
- 26-187
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confident Moves Intervention Efficacy Trial: Obesity Care Settings
- ClinicalTrials.gov ID
- NCT07623772
- Acronym / sponsor ID
- 26-187
- Conditions
- Obesity, Overweight
- Keywords
- eHealth, Internet applications, information and communication technologies, exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Collaborators
- Michigan State University
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Confident Moves (CM) InterventionParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Failure to meet one or more of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Confident Moves (CM) InterventionAlso: Physical Activity Self-efficacy (PAS) InterventionConfident 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. | Behavioural | CM Group |
Primary outcome
ActiGraph wGT3X-BT
Time frame: At W1 (Week 1-4) and W3 (Week 13-16)
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.
Whole Person Health Index (WPHI) scale
Time frame: At W1 (Week 1-4) and W3 (Week 13-16)
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.
8 secondary outcomes
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)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Confident Moves (CM) Intervention in people with Obesity and Overweight, run by Iowa State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seungmin Lee, PhD (515-294-8257, seunglee@iastate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ActiGraph wGT3X-BT (time frame: At W1 (Week 1-4) and W3 (Week 13-16)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.