A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Designing With Dissemination in Mind: Development and Evaluation of a Theory-based Physical Activity Intervention Using the Multiphase Optimization Strategy: Aim 2
2 other identifiers
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2023
CompletedFirst Posted
Study publicly available on registry
November 3, 2023
CompletedStudy Start
First participant enrolled
December 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
May 14, 2024
May 1, 2024
2.8 years
October 12, 2023
May 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Acceptability of the Move physical activity support program - Qualitative
Acceptability of the Move physical activity support program will be assessed with results of the semi-structured focus groups or interviews from the participant and provider perspectives.
6 months
Feasibility of the Move physical activity support program - Qualitative
Feasibility of the Move physical activity support program will be assessed with results of the semi-structured focus groups or interviews from the participant and provider perspectives.
6 months
Secondary Outcomes (2)
Acceptability of the Move physical activity support program components - Quantitative
6 months
Feasibility of the Move physical activity support program - Quantitative
6 months
Study Arms (8)
PreventT2 + Move group-based classes
EXPERIMENTALParticipants 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.
PreventT2 + Move group-based classes + Fitness Membership
EXPERIMENTALParticipants 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.
PreventT2 + Move group-based classes + Mental Imagery
EXPERIMENTALParticipants 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.
PreventT2 + Move group-based classes + Mental Imagery + Fitness Membership
EXPERIMENTALParticipants 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.
PreventT2 + Move group-based classes + Move 1:1 Support
EXPERIMENTALParticipants 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.
PreventT2 + Move group-based classes + Fitness Membership + Move 1:1 Support
EXPERIMENTALParticipants 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.
PreventT2 + Move group-based classes + Mental Imagery + Move 1:1 Support
EXPERIMENTALParticipants 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.
PreventT2 + Move group-based classes + Fitness Membership + Mental Imagery + Move 1:1 Support
EXPERIMENTALParticipants 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.
Interventions
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- For the provider participants only:
- \>1 year experience with delivering lifestyle interventions involving changes in diet and/or exercise behaviors.
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Danielle Ostendorf, PhD
University of Colorado, Denver
Central Study Contacts
Danielle M Ostendorf, PhD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Trials participants will know their intervention condition as will the lay coach involved in delivering the intervention. Assessors measuring body composition (DXA), self-reported energy intake, and metabolic parameters will be blinded to participant condition.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2023
First Posted
November 3, 2023
Study Start
December 4, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
May 14, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share