Physical InactivityNCT06116435
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
A study testing Prevent T2, Move group-based classes and Fitness Membership in people with Physical Inactivity and Overweight and Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about the feasibility and acceptability of integrating the Move physical activity support program within an existing lifestyle intervention program. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity, Overweight and Obesity
- What is being tested?
- Prevent T2, Move group-based classes and Fitness Membership
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to Mar 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all types of research participants:
- Men and Women
- Age 18-65 years
- Have access to a computer and/or smart phone, and Wi-Fi
- Speak English (since all study materials are in English and the intervention will be delivered in a group-class setting with a coach who speaks English, we are only able to accommodate English-speakers at this time)
- For the patient participants only:
Show all 13Show fewer
- Body Mass Index 25-45 kg/m2
- Insufficiently active (defined as <150 min/week of voluntary exercise at moderate intensity over the past 3 months)
- Willing not to enroll in any other formal weight loss, or physical activity program over the next 5 months.
- Have a primary care physician (or has access to a healthcare professional and/or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures/interventions.
- Capable and willing to give informed consent, understand exclusion criteria, attend the Move program sessions, and complete outcome measures.
- For the provider participants only:
- >1 year experience with delivering lifestyle interventions involving changes in diet and/or exercise behaviors.
Who cannot join
- For patient participants:
- Considered high risk, based on the American College of Sports Medicine Guidelines for Exercise Testing and Prescription (i.e. have cardiovascular disease symptoms or known cardiovascular disease, diabetes, or end-stage renal disease).
- Females who are currently pregnant or lactating, were pregnant within the past 3 months, or planning to become pregnant in the next 5 months will also be excluded
- Self-reported cardiovascular disease:
- Cardiac, peripheral vascular, or cerebrovascular disease
- Self-reported symptoms suggestive of cardiovascular disease: pain, discomfort in the chest, neck, jaw, arms, or other areas that may result from cardiac ischemia; shortness of breath at rest or with mild exertion; dizziness or syncope; orthopnea or paroxysmal nocturnal dyspnea; ankle edema; palpitations or tachycardia; intermittent claudication
Show all 23Show fewer
- Self-reported end-stage renal disease
- Self-reported diabetes (history of type 1 or type 2 diabetes)
- Uncontrolled hypertension, defined as diastolic blood pressure >100 mmHG, systolic blood pressure >160 mmHG, or resting heart rate >100 bpm as measured in duplicate at the screening visit after 5 minutes of rest in a seated position.
- Self-reported pulmonary disease requiring chronic oxygen supplementation; severe asthma or chronic obstructive pulmonary disease requiring hospitalization in past year.
- Plans to relocate in the next 16 months
- Currently participating in or planning to participate in any formal weight loss, dietary modification, or physical activity/exercise programs or clinical trials.
- Current severe depression or history of severe depression within the previous year, based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for Major Depressive Episode. Score > 18 on Beck Depression Inventory (BDI) will require further assessment by the Study Medical Doctor (MD) to determine if it is appropriate for the subject to participate in the study.
- History of other significant psychiatric illnesses (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to the exercise intervention.
- History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder. Score >20 on the Eating Attitudes Test (EATS-26) or pattern of response on the Questionnaire on Eating and Weight Patterns-5 (QEWP-5) suggestive of possible binge eating disorder or bulimia will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.
- Current alcohol or substance abuse
- Nicotine use (current or past 6 months)
- Regular use of prescription or over-the-counter medications known to significantly impact appetite, weight, sleep, or energy metabolism (e.g., appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants)
- Regular use of obesity pharmacotherapeutic agents within the last 6 months.
- Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed > 1 year before screening, (2) lap banding if the band has been removed > 1 year before screening, (3) intragastric balloon if the balloon has been removed > 1 year before screening (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening or 5) AspireAssist or other endoscopically placed weight loss device if the device has been removed > 1 year before screening.
- Currently has access to and uses a fitness membership (defined as having used membership within the past month)
- For provider participants:
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Knoxville
Knoxville, Tennessee, 37996
About this study
Official title: Designing With Dissemination in Mind: Development and Evaluation of a Theory-based Physical Activity Intervention Using the Multiphase Optimization Strategy: Aim 2
This study plans to learn more about the feasibility and acceptability of integrating the Move physical activity support program within an existing lifestyle intervention program.
- Conditions
- Physical Inactivity, Overweight and Obesity
- Being tested
- Prevent T2, Move group-based classes, Fitness Membership, Mental Imagery, Move 1:1 Support
- Keywords
- physical activity, obesity, weight loss, nutrition, diet, lifestyle intervention
- Medical subject headings
- Sedentary Behavior, Overweight, Obesity, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevent T2Behavioural
The PreventT2 curriculum is based on the original 2002 Diabetes Prevention Prevention (DPP) trial and follow-up studies. It promotes modest weight loss (5-7%) and increased physical activity through a lifestyle change program and also reflects new literature on self-efficacy, physical activity, and diet. There are 16 modules that will be delivered over 6 months. Participants will receive a calorie goal and be asked to count calories in order to reduce their caloric intake.
Move group-based classesBehavioural
The Move physical activity support program group-based classes are based on Self-Determination Theory and encourage improvements in autonomous motivation for physical activity. These group-based classes are integrated within the Prevent T2 program curricula.
Fitness MembershipBehavioural
Participants will receive 6 months of the Peloton fitness membership. This includes access to livestream and on-demand fitness classes including walking, strength training, yoga, meditation, stretching, etc.
Mental ImageryBehavioural
Participants will receive access to positive mental guided imagery recordings. Recordings describe a pleasant experience while walking and range from 2-8 minutes in duration.
Move 1:1 SupportBehavioural
Participants will meet individually with their class instructor to receive personalized recommendations on how to incorporate messages from the Move group-based classes into their daily lives. Sessions are based on Self-Determination Theory and will last approximately 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| PreventT2 + Move group-based classes | Experimental | Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Receives: Behavioral: Prevent T2; Behavioral: Move group-based classes |
| PreventT2 + Move group-based classes + Fitness Membership | Experimental | Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive a 6-month membership to the Peloton fitness app. Receives: Behavioral: Prevent T2; Behavioral: Move group-based classes; Behavioral: Fitness Membership |
| PreventT2 + Move group-based classes + Mental Imagery | Experimental | Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. In addition, participants will receive access to online mental guided imagery sessions. Guided positive exercise imagery scripts were developed based on work from Williams et al. and prompt several sensory and emotional experiences. Receives: Behavioral: Prevent T2; Behavioral: Move group-based classes; Behavioral: Mental Imagery |
| PreventT2 + Move group-based classes + Mental Imagery + Fitness Membership | Experimental | Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive a 6-month membership to the Peloton fitness app. In addition, participants will receive access to online mental guided imagery sessions. Guided positive exercise imagery scripts were developed based on work from Williams et al. and prompt several sensory and emotional experiences. Receives: Behavioral: Prevent T2; Behavioral: Move group-based classes; Behavioral: Fitness Membership; Behavioral: Mental Imagery |
| PreventT2 + Move group-based classes + Move 1:1 Support | Experimental | Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive Move individualized support sessions. The 1:1 support sessions are designed to help participants adopt the physical activity messages from each Move group-based class into their daily lives. Receives: Behavioral: Prevent T2; Behavioral: Move group-based classes; Behavioral: Move 1:1 Support |
| PreventT2 + Move group-based classes + Fitness Membership + Move 1:1 Support | Experimental | Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive a 6-month membership to the Peloton fitness app. Participants will also receive Move individualized support sessions. The 1:1 support sessions are designed to help participants adopt the physical activity messages from each Move group-based class into their daily lives. Receives: Behavioral: Prevent T2; Behavioral: Move group-based classes; Behavioral: Fitness Membership; Behavioral: Move 1:1 Support |
| PreventT2 + Move group-based classes + Mental Imagery + Move 1:1 Support | Experimental | Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive Move individualized support sessions. The 1:1 support sessions are designed to help participants adopt the physical activity messages from each Move group-based class into their daily lives. In addition, participants will receive access to online mental guided imagery sessions. Guided positive exercise imagery scripts were developed based on work from Williams et al. and prompt several sensory and emotional experiences. Receives: Behavioral: Prevent T2; Behavioral: Move group-based classes; Behavioral: Mental Imagery; Behavioral: Move 1:1 Support |
| PreventT2 + Move group-based classes + Fitness Membership + Mental Imagery + Move 1:1 Support | Experimental | Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum, integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian. Participants will also receive a 6-month membership to the Peloton fitness app. Participants will also receive Move individualized support sessions. In addition, participants will receive access to online mental guided imagery sessions. Receives: Behavioral: Prevent T2; Behavioral: Move group-based classes; Behavioral: Fitness Membership; Behavioral: Mental Imagery; Behavioral: Move 1:1 Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the Move physical activity support program - Qualitative
Acceptability of the Move physical activity support program will be assessed with results of the semi-structured focus groups or interviews from the participant and provider perspectives.
Measured: 6 months
Feasibility of the Move physical activity support program - Qualitative
Feasibility of the Move physical activity support program will be assessed with results of the semi-structured focus groups or interviews from the participant and provider perspectives.
Measured: 6 months
Secondary outcomes (2)
Acceptability of the Move physical activity support program components - Quantitative
Acceptability of the integrated Move physical activity support program components will be assessed using the Net Promoter Score (NPS) from the participant and provider perspectives. Scores range from -100 to +100, with higher scores indicating a better outcome.
Measured: 6 months
Feasibility of the Move physical activity support program - Quantitative
Feasibility of the Move physical activity support program will be assessed using the Perceived Characteristics of Intervention Scale (PCIS) collected only at the level of the provider. Scores range from 0 to 4, with higher scores indicating a better outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start4 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- 2x2x2 full factorial pilot randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Tennessee
- Responsible party
- Sponsor
- Investigators
- Danielle Ostendorf, PhD, Principal investigator, University of Tennessee Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116435
- Sponsor's protocol ID
- 23-1154
- Other IDs
- K01HL161417
- Status last verified
- Nov 2026
- First submitted
- 12 Oct 2023
- Last updated
- 6 Nov 2026
- Results posted
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing With Dissemination in Mind: Development and Evaluation of a Theory-based Physical Activity Intervention Using the Multiphase Optimization Strategy: Aim 2
- ClinicalTrials.gov ID
- NCT06116435
- Acronym / sponsor ID
- 23-1154
- Conditions
- Physical Inactivity, Overweight and Obesity
- Keywords
- physical activity, obesity, weight loss, nutrition, diet, lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Tennessee
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Nov 2023 (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.
This study plans to learn more about the feasibility and acceptability of integrating the Move physical activity support program within an existing lifestyle intervention program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
- Model description
- 2x2x2 full factorial pilot randomized trial
| Arm | Type | Receives |
|---|---|---|
| PreventT2 + Move group-based classes | Experimental | Behavioral: Prevent T2, Behavioral: Move group-based classesParticipants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. |
| PreventT2 + Move group-based classes + Fitness Membership | Experimental | Behavioral: Prevent T2, Behavioral: Move group-based classes, Behavioral: Fitness MembershipParticipants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive a 6-month membership to the Peloton fitness app. |
| PreventT2 + Move group-based classes + Mental Imagery | Experimental | Behavioral: Prevent T2, Behavioral: Move group-based classes, Behavioral: Mental ImageryParticipants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. In addition, participants will receive access to online mental guided imagery sessions. Guided positive exercise imagery scripts were developed based on work from Williams et al. and prompt several sensory and emotional experiences. |
| PreventT2 + Move group-based classes + Mental Imagery + Fitness Membership | Experimental | Behavioral: Prevent T2, Behavioral: Move group-based classes, Behavioral: Fitness Membership, Behavioral: Mental ImageryParticipants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive a 6-month membership to the Peloton fitness app. In addition, participants will receive access to online mental guided imagery sessions. Guided positive exercise imagery scripts were developed based on work from Williams et al. and prompt several sensory and emotional experiences. |
| PreventT2 + Move group-based classes + Move 1:1 Support | Experimental | Behavioral: Prevent T2, Behavioral: Move group-based classes, Behavioral: Move 1:1 SupportParticipants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive Move individualized support sessions. The 1:1 support sessions are designed to help participants adopt the physical activity messages from each Move group-based class into their daily lives. |
| PreventT2 + Move group-based classes + Fitness Membership + Move 1:1 Support | Experimental | Behavioral: Prevent T2, Behavioral: Move group-based classes, Behavioral: Fitness Membership, Behavioral: Move 1:1 SupportParticipants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive a 6-month membership to the Peloton fitness app. Participants will also receive Move individualized support sessions. The 1:1 support sessions are designed to help participants adopt the physical activity messages from each Move group-based class into their daily lives. |
| PreventT2 + Move group-based classes + Mental Imagery + Move 1:1 Support | Experimental | Behavioral: Prevent T2, Behavioral: Move group-based classes, Behavioral: Mental Imagery, Behavioral: Move 1:1 SupportParticipants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive Move individualized support sessions. The 1:1 support sessions are designed to help participants adopt the physical activity messages from each Move group-based class into their daily lives. In addition, participants will receive access to online mental guided imagery sessions. Guided positive exercise imagery scripts were developed based on work from Williams et al. and prompt several sensory and emotional experiences. |
| PreventT2 + Move group-based classes + Fitness Membership + Mental Imagery + Move 1:1 Support | Experimental | Behavioral: Prevent T2, Behavioral: Move group-based classes, Behavioral: Fitness Membership, Behavioral: Mental Imagery, Behavioral: Move 1:1 SupportParticipants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum, integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian. Participants will also receive a 6-month membership to the Peloton fitness app. Participants will also receive Move individualized support sessions. In addition, participants will receive access to online mental guided imagery sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- For all types of research participants:
- For the patient participants only:
- For the provider participants only:
Key exclusion criteria (23 listed)
- For patient participants:
- For provider participants:
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 |
|---|---|---|
| Prevent T2The PreventT2 curriculum is based on the original 2002 Diabetes Prevention Prevention (DPP) trial and follow-up studies. It promotes modest weight loss (5-7%) and increased physical activity through a lifestyle change program and also reflects new literature on self-efficacy, physical activity, and diet. There are 16 modules that will be delivered over 6 months. Participants will receive a calorie goal and be asked to count calories in order to reduce their caloric intake. | Behavioural | PreventT2 + Move group-based classes, PreventT2 + Move group-based classes + Fitness Membership, PreventT2 + Move group-based classes + Fitness Membership + Mental Imagery + Move 1:1 Support, PreventT2 + Move group-based classes + Fitness Membership + Move 1:1 Support, PreventT2 + Move group-based classes + Mental Imagery, PreventT2 + Move group-based classes + Mental Imagery + Fitness Membership, PreventT2 + Move group-based classes + Mental Imagery + Move 1:1 Support, PreventT2 + Move group-based classes + Move 1:1 Support |
| Move group-based classesThe Move physical activity support program group-based classes are based on Self-Determination Theory and encourage improvements in autonomous motivation for physical activity. These group-based classes are integrated within the Prevent T2 program curricula. | Behavioural | PreventT2 + Move group-based classes, PreventT2 + Move group-based classes + Fitness Membership, PreventT2 + Move group-based classes + Fitness Membership + Mental Imagery + Move 1:1 Support, PreventT2 + Move group-based classes + Fitness Membership + Move 1:1 Support, PreventT2 + Move group-based classes + Mental Imagery, PreventT2 + Move group-based classes + Mental Imagery + Fitness Membership, PreventT2 + Move group-based classes + Mental Imagery + Move 1:1 Support, PreventT2 + Move group-based classes + Move 1:1 Support |
| Fitness MembershipParticipants will receive 6 months of the Peloton fitness membership. This includes access to livestream and on-demand fitness classes including walking, strength training, yoga, meditation, stretching, etc. | Behavioural | PreventT2 + Move group-based classes + Fitness Membership, PreventT2 + Move group-based classes + Fitness Membership + Mental Imagery + Move 1:1 Support, PreventT2 + Move group-based classes + Fitness Membership + Move 1:1 Support, PreventT2 + Move group-based classes + Mental Imagery + Fitness Membership |
| Mental ImageryParticipants will receive access to positive mental guided imagery recordings. Recordings describe a pleasant experience while walking and range from 2-8 minutes in duration. | Behavioural | PreventT2 + Move group-based classes + Fitness Membership + Mental Imagery + Move 1:1 Support, PreventT2 + Move group-based classes + Mental Imagery, PreventT2 + Move group-based classes + Mental Imagery + Fitness Membership, PreventT2 + Move group-based classes + Mental Imagery + Move 1:1 Support |
| Move 1:1 SupportParticipants will meet individually with their class instructor to receive personalized recommendations on how to incorporate messages from the Move group-based classes into their daily lives. Sessions are based on Self-Determination Theory and will last approximately 45 minutes. | Behavioural | PreventT2 + Move group-based classes + Fitness Membership + Mental Imagery + Move 1:1 Support, PreventT2 + Move group-based classes + Fitness Membership + Move 1:1 Support, PreventT2 + Move group-based classes + Mental Imagery + Move 1:1 Support, PreventT2 + Move group-based classes + Move 1:1 Support |
Primary outcome
Acceptability of the Move physical activity support program - Qualitative
Time frame: 6 months
Acceptability of the Move physical activity support program will be assessed with results of the semi-structured focus groups or interviews from the participant and provider perspectives.
Feasibility of the Move physical activity support program - Qualitative
Time frame: 6 months
Feasibility of the Move physical activity support program will be assessed with results of the semi-structured focus groups or interviews from the participant and provider perspectives.
2 secondary outcomes
Acceptability of the Move physical activity support program components - Quantitative
Time frame: 6 months
Feasibility of the Move physical activity support program - Quantitative
Time frame: 6 months
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 6 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Physical Inactivity
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Be Well at Work-Plus: A Depression and Physical Activity Intervention for Hospital Service Workers (Aim 3)
Depression, Physical Inactivity
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
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. This study is not recruiting at the moment.
Danielle Ostendorf, PhD principal investigator
University of Tennessee Knoxville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevent T2, Move group-based classes and Fitness Membership in people with Physical Inactivity and Overweight and Obesity, run by University of Colorado, Denver at 1 site in United States.
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 13 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the Move physical activity support program - Qualitative (time frame: 6 months). 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 6 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.