Integrated Lifestyle Intervention for Physical Inactivity and Overweight/Obesity
This study is exploring new ways to help people become more active and manage their weight. It's testing different combinations of support programs, including the "Prevent T2" curriculum, "Move group-based classes," a "Peloton fitness membership," "Mental Imagery" recordings, and "Move 1:1 Support." The goal is to see how well these programs work together and if people find them helpful. You might be able to join if you are between 18 and 65 years old, have access to a computer or smartphone with Wi-Fi, and speak English. The study will measure how acceptable and practical these programs are after 6 months.
- Study design
- This is an interventional study planning to enroll 64 participants. It is a pilot factorial trial, meaning it tests different combinations of interventions.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes are measured at 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06116435
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Recruiting
NAAges 18–65InterventionalTreatmentUniversity of Colorado, DenverInvestigator-initiated
~64 participants
Updated 2024-05-14 on ClinicalTrials.gov
What's tested:Prevent T2Move group-based classesFitness MembershipMental ImageryMove 1:1 Support
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptability of the Move physical activity support program - Qualitative
Measured over 6 months
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesColorado1
Study leadership
- Danielle Ostendorf, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
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.
Exclusion
For the provider participants only:
\>1 year experience with delivering lifestyle interventions involving changes in diet and/or exercise behaviors.
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
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
What this trial measures
- Acceptability of the Move physical activity support program - Qualitative6 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 - Qualitative6 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.