A Pilot Factorial Trial of an Integrated Lifestyle Intervention

Official title

Designing With Dissemination in Mind: Development and Evaluation of a Theory-based Physical Activity Intervention Using the Multiphase Optimization Strategy: Aim 2

Overview

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.

Interventions

• Behavioral Prevent T2
  The PreventT2 curriculum is based on the original 2002 Diabetes Prevention Prevention (DPP) trial and follow-up studies. It promotes modest weight loss (5-7%) and increased physical activity through a lifestyle change program and also reflects new literature on self-efficacy, physical activity, and diet. There are 16 modules that will be delivered over 6 months. Participants will receive a calorie goal and be asked to count calories in order to reduce their caloric intake.
• Behavioral Move group-based classes
  The Move physical activity support program group-based classes are based on Self-Determination Theory and encourage improvements in autonomous motivation for physical activity. These group-based classes are integrated within the Prevent T2 program curricula.
• Behavioral Fitness Membership
  Participants will receive 6 months of the Peloton fitness membership. This includes access to livestream and on-demand fitness classes including walking, strength training, yoga, meditation, stretching, etc.
• Behavioral Mental Imagery
  Participants will receive access to positive mental guided imagery recordings. Recordings describe a pleasant experience while walking and range from 2-8 minutes in duration.
• Behavioral Move 1:1 Support
  Participants will meet individually with their class instructor to receive personalized recommendations on how to incorporate messages from the Move group-based classes into their daily lives. Sessions are based on Self-Determination Theory and will last approximately 45 minutes.

Primary outcome measures

• Acceptability of the Move physical activity support program - Qualitative [Time frame: 6 months]
• Feasibility of the Move physical activity support program - Qualitative [Time frame: 6 months]

Secondary outcome measures (2)

• Acceptability of the Move physical activity support program components - Quantitative [Time frame: 6 months]
• Feasibility of the Move physical activity support program - Quantitative [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Factorial

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Colorado Anschutz Medical Campus — Aurora

Identifiers

NCT: NCT06116435 · 23-1154 · K01HL161417

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗