What is this study trying to find out about physical inactivity and obesity?

This study aims to learn how well the Move physical activity support program works when combined with the Prevent T2 lifestyle program for adults who are overweight or obese and physically inactive. It focuses on how acceptable and practical this combined approach is for participants. The University of Colorado, Denver is leading this research to improve lifestyle interventions.

Who may be eligible for this physical inactivity and obesity clinical trial?

Adults aged 18 to 65 years who are overweight or obese with a BMI between 25 and 45, and who are not regularly physically active, may be eligible. Participants must have access to a computer or smartphone with Wi-Fi and speak English. Women who are pregnant, breastfeeding, or planning pregnancy soon are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this physical inactivity and obesity clinical trial?

Study-related care, including the program and all trial visits, is provided at no cost. Personal travel expenses or other costs are not guaranteed to be covered and may vary. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 65Years

All Genders

Healthy Volunteers

ID06116435

Pilot Study of an Integrated 6-Month Lifestyle and Physical Activity Program Using PreventT2 and Move Group-Based Classes with Optional Fitness Membership, Mental Imagery, and Personalized Support

Led by University of Colorado, Denver · Updated on 2024-05-14

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating how feasible and acceptable it is to combine the Move physical activity support program with an existing lifestyle weight management program called Prevent T2. This study focuses on adults aged 18 to 65 who are overweight or obese and physically inactive. The goal is to understand how well these programs work together to support healthier lifestyles. Participants will engage in a 6-month lifestyle weight management program based on the Prevent T2 curriculum, which encourages modest weight loss and increased physical activity. Group classes from the Move program will be delivered virtually by a registered dietitian weekly for the first 12 weeks and biweekly for the following 14 weeks. Some participants will also receive additional support like a 6-month Peloton fitness app membership, online mental guided imagery sessions, and personalized 1-on-1 Move support to help integrate physical activity into daily life. During the study, participants will attend virtual group classes and may use fitness apps or participate in mental imagery sessions depending on their assigned group. Researchers will collect feedback on how acceptable and feasible the Move program and its components are over 6 months. They will monitor participants engagement and outcomes through qualitative and quantitative methods. The study aims to understand how well these combined interventions can support lifestyle changes in adults with overweight or obesity.

CONDITIONS

Brief Title

A Pilot Factorial Trial of an Integrated Lifestyle Intervention

Who Can Participate

Age: 18Years - 65Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Men and women aged 18-65 years
Access to a computer and/or smartphone with Wi-Fi
English-speaking
Body Mass Index (BMI) between 25 and 45 kg/m2
Insufficiently active (less than 150 minutes per week of moderate exercise over past 3 months)
Willing to avoid enrolling in other formal weight loss or physical activity programs for 5 months
Have or willing to establish care with a primary care physician
Capable and willing to give informed consent, attend sessions, and complete study measures
For providers: more than 1 year experience delivering lifestyle interventions involving diet and/or exercise changes

You will not qualify if you...

High risk based on American College of Sports Medicine guidelines (e.g., cardiovascular disease symptoms, known cardiovascular disease, diabetes, end-stage renal disease)
Females currently pregnant, lactating, pregnant within past 3 months, or planning pregnancy in next 5 months
Self-reported cardiovascular disease or symptoms suggestive of it
Self-reported end-stage renal disease or diabetes
Uncontrolled hypertension (diastolic >100 mmHg, systolic >160 mmHg) or resting heart rate >100 bpm at screening
Pulmonary disease requiring chronic oxygen, severe asthma, or recent hospitalization for COPD
Plans to relocate within 16 months
Currently participating or planning to participate in other formal weight loss, diet modification, or physical activity programs
Current severe depression or history within past year, or significant psychiatric illnesses affecting adherence
History of eating disorders or high scores on related assessments requiring further evaluation
Current alcohol or substance abuse
Nicotine use in past 6 months
Regular use of medications affecting appetite, weight, sleep, or metabolism
Use of obesity drugs within last 6 months
Previous obesity surgery or weight loss device unless more than 1 year before screening
Current access to or use of a fitness membership within past month
No exclusion criteria for provider participants

Research Team

Danielle M Ostendorf, PhD

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Pilot Study of an Integrated 6-Month Lifestyle and Physical Activity Program Using PreventT2 and Move Group-Based Classes with Optional Fitness Membership, Mental Imagery, and Personalized Support

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria