A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Status
Enrolling
Conditions
Physical Inactivity
Overweight and Obesity
Treatments
Behavioral: Mental Imagery
Behavioral: Fitness Membership
Behavioral: Move group-based classes
Behavioral: Move 1:1 Support
Behavioral: Prevent T2
Study type
Interventional
Funder types
Other
NIH
Identifiers
Details and patient eligibility
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.
Enrollment
64 estimated patients
Sex
All
Ages
18 to 65 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
-
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 criteria
-
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Factorial Assignment
Masking
Single Blind
64 participants in 8 patient groups
PreventT2 + Move group-based classes
Experimental group
Description:
Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core.
Treatment:
Behavioral: Move group-based classes
Behavioral: Prevent T2
PreventT2 + Move group-based classes + Fitness Membership
Experimental group
Description:
Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive a 6-month membership to the Peloton fitness app.
Treatment:
Behavioral: Move group-based classes
Behavioral: Prevent T2
Behavioral: Fitness Membership
PreventT2 + Move group-based classes + Mental Imagery
Experimental group
Description:
Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. In addition, participants will receive access to online mental guided imagery sessions. Guided positive exercise imagery scripts were developed based on work from Williams et al. and prompt several sensory and emotional experiences.
Treatment:
Behavioral: Move group-based classes
Behavioral: Prevent T2
Behavioral: Mental Imagery
PreventT2 + Move group-based classes + Mental Imagery + Fitness Membership
Experimental group
Description:
Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive a 6-month membership to the Peloton fitness app. In addition, participants will receive access to online mental guided imagery sessions. Guided positive exercise imagery scripts were developed based on work from Williams et al. and prompt several sensory and emotional experiences.
Treatment:
Behavioral: Move group-based classes
Behavioral: Prevent T2
Behavioral: Mental Imagery
Behavioral: Fitness Membership
PreventT2 + Move group-based classes + Move 1:1 Support
Experimental group
Description:
Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive Move individualized support sessions. The 1:1 support sessions are designed to help participants adopt the physical activity messages from each Move group-based class into their daily lives.
Treatment:
Behavioral: Move group-based classes
Behavioral: Prevent T2
Behavioral: Move 1:1 Support
PreventT2 + Move group-based classes + Fitness Membership + Move 1:1 Support
Experimental group
Description:
Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive a 6-month membership to the Peloton fitness app. Participants will also receive Move individualized support sessions. The 1:1 support sessions are designed to help participants adopt the physical activity messages from each Move group-based class into their daily lives.
Treatment:
Behavioral: Move group-based classes
Behavioral: Prevent T2
Behavioral: Fitness Membership
Behavioral: Move 1:1 Support
PreventT2 + Move group-based classes + Mental Imagery + Move 1:1 Support
Experimental group
Description:
Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum (formally known as the National Diabetes Prevention Program), integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian from the Colorado Nutrition Obesity Research Center Clinical Intervention and Translation (CIT) Core. Participants will also receive Move individualized support sessions. The 1:1 support sessions are designed to help participants adopt the physical activity messages from each Move group-based class into their daily lives. In addition, participants will receive access to online mental guided imagery sessions. Guided positive exercise imagery scripts were developed based on work from Williams et al. and prompt several sensory and emotional experiences.
Treatment:
Behavioral: Move group-based classes
Behavioral: Prevent T2
Behavioral: Mental Imagery
Behavioral: Move 1:1 Support
PreventT2 + Move group-based classes + Fitness Membership + Mental Imagery + Move 1:1 Support
Experimental group
Description:
Participants will receive a 6-month lifestyle weight management program based on the publicly available Prevent T2 curriculum, integrated with the Move group-based classes. Group classes will be delivered weekly in weeks 1-12, and biweekly in weeks 13-26. Group-based classes will be taught virtually by a trained Registered Dietitian. Participants will also receive a 6-month membership to the Peloton fitness app. Participants will also receive Move individualized support sessions. In addition, participants will receive access to online mental guided imagery sessions.
Treatment:
Behavioral: Move group-based classes
Behavioral: Prevent T2
Behavioral: Mental Imagery
Behavioral: Fitness Membership
Behavioral: Move 1:1 Support
Trial contacts and locations
1
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Central trial contact
Danielle M Ostendorf, PhD; Danielle M Ostendorf, PhD
Data sourced from clinicaltrials.gov
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