Status:
RECRUITING
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Physical Inactivity
Overweight and Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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.
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.
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06116435
Start Date
December 4 2023
End Date
March 1 2027
Last Update
May 14 2024
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045