Actively Recruiting
Designing With Dissemination in Mind: Development and Evaluation of a Theory-based Physical Activity Intervention Using the Multiphase Optimization Strategy: Aim 2
Led by University of Colorado, Denver · Updated on 2024-05-14
64
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
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
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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) for eligibility assessment
Duration - 6 months
Participants receive a 6-month lifestyle weight management program based on the Prevent T2 curriculum integrated with Move group-based classes. Group classes are delivered weekly during the first 12 weeks, then biweekly for the next 14 weeks. Additional interventions such as Peloton fitness membership, access to mental guided imagery sessions, and individualized 1:1 Move support sessions may be provided depending on the assigned group.
Weekly group classes for 12 weeks, then biweekly group classes for 14 weeks; additional individual sessions depending on group assignment
Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
D
Danielle M Ostendorf, PhD
D
Danielle M Ostendorf, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
8
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