Actively Recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Led by University of Colorado, Denver · Updated on 2024-05-14
64
Participants Needed
1
Research Sites
169 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
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
Official 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 to 65 years
- Access to a computer and/or smartphone with Wi-Fi
- Speak English
- Body Mass Index between 25 and 45 kg/m2 (patients only)
- Insufficiently active, defined as less than 150 minutes per week of moderate exercise over the past 3 months (patients only)
- Willing not to enroll in other formal weight loss or physical activity programs for 5 months (patients only)
- Have or willing to establish care with a primary care physician (patients only)
- Capable and willing to give informed consent, attend program sessions, and complete outcome measures (patients only)
- More than 1 year of experience delivering lifestyle interventions involving diet and/or exercise changes (providers only)
You will not qualify if you...
- High risk based on American College of Sports Medicine Guidelines, including cardiovascular disease symptoms or known cardiovascular disease, diabetes, or end-stage renal disease (patients only)
- Females currently pregnant, lactating, pregnant within past 3 months, or planning pregnancy in next 5 months (patients only)
- Self-reported cardiovascular disease or symptoms suggestive of it
- Self-reported end-stage renal disease
- Self-reported diabetes (type 1 or type 2)
- Uncontrolled hypertension (diastolic >100 mmHg, systolic >160 mmHg, resting heart rate >100 bpm) measured at screening (patients only)
- Pulmonary disease requiring chronic oxygen, severe asthma, or COPD requiring hospitalization in past year (patients only)
- Plans to relocate within next 16 months
- Currently or planning to participate in other formal weight loss, dietary, physical activity programs, or clinical trials
- Current or recent severe depression or history within past year; score >18 on Beck Depression Inventory requires further assessment
- History of significant psychiatric illnesses that interfere with exercise adherence
- History of clinically diagnosed eating disorders; scores indicating possible disorders require further assessment
- Current alcohol or substance abuse
- Nicotine use within past 6 months
- Regular use of medications impacting appetite, weight, sleep, or energy metabolism
- Use of obesity medications within last 6 months
- Previous obesity surgery or device treatment unless removed more than 1 year before screening
- Current access to and use of a fitness membership within past month (patients only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
D
Danielle M Ostendorf, PhD
CONTACT
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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