- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04937205
Motivation for Exercise and Physical Activity Adherence (MOVE)
June 15, 2021 updated by: University of Colorado, Denver
Understanding Motivation for Exercise to Enhance Physical Activity Adherence in Adults With Obesity
The limited success of our current approaches to increase adoption and maintenance of physical activity in adults with overweight and obesity is a substantial barrier to effectively address the current obesity epidemic.
This mentored F32 application addresses the significant public health issue of obesity and associated risk of major chronic diseases by using mixed methods research to optimize an innovative, theoretically based physical activity intervention designed to enhance motivation for exercise in adults with overweight and obesity.
Study Overview
Detailed Description
Physical activity (PA) is one of the best predictors of sustained weight loss and current guidelines recommend high levels of PA to prevent weight regain after weight loss.
However, long-term adherence to PA is generally poor when adults with overweight/obesity are provided an exercise prescription consistent with current guidelines.
Thus, it is essential to evaluate novel strategies to enhance adoption and maintenance of PA in adults with overweight/obesity.
The overall goal of this mentored F32 application is to use mixed methods research to optimize an innovative, theoretically based PA intervention designed to enhance motivation for exercise in adults with overweight/obesity.
Specifically, the objectives of this proposal are to evaluate and optimize a theory-based PA intervention (called MOVE) designed to enhance motivation for exercise as a sub-study of an ongoing weight loss "parent" trial (COMIRB, Protocol #17-0369).
In Aim 1, adults from an ongoing behavioral weight loss trial (R01DK111622) will receive the MOVE intervention and participate in focus groups to explore how participants experience MOVE.
In Aim 2, we will use a mixed methods convergent design to integrate quantitative results from a secondary data analysis and qualitative results (Aim 1) to optimize MOVE in preparation for a full evaluation of MOVE in a future randomized controlled study.
Study Type
Observational
Enrollment (Actual)
39
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Anschutz Medical Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Volunteers from the parent trial who are eligible and willing to participate were included in the focus groups.
To achieve aim 1 of this proposal, participants randomized to cohorts 2-4 of the parent study who have completed at least 2 of the 3 MOVE components were invited to participate in a focus group.
Description
Inclusion Criteria:
- A current study participant randomized to the parent trial in cohorts 2-4 for COMIRB, Protocol #17-0369
- Completed at least 2 of 3 MOVE program components (attended ≥80% of either group-based class and/or attended the one-on-one support session).
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cohort 2
This group of study participants started the 52-week parent randomized controlled trial (NCT03411356) on February 13, 2019.
|
The MOVE physical activity support program is based on the Self-Determination Theory and targets autonomous motivation for physical activity by encouraging 1) choice in physical activity type (e.g.
walking, household chores, yoga), 2) a meaningful, value-based rationale for engaging in physical activity, and 3) physical activity that is intrinsically enjoyable.
MOVE was delivered during two, 60-75 minute group-based classes and one, 45 minute individualized 1:1 support session to enhance adherence to physical activity recommendations within a lifestyle weight loss program.
The group-based classes included a combination of PowerPoint slides, participant handouts, and group-based discussions.
All MOVE content was delivered by trained study staff.
|
|
Cohort 3
This group of study participants started the 52-week parent randomized controlled trial (NCT03411356) on November 5, 2019.
|
The MOVE physical activity support program is based on the Self-Determination Theory and targets autonomous motivation for physical activity by encouraging 1) choice in physical activity type (e.g.
walking, household chores, yoga), 2) a meaningful, value-based rationale for engaging in physical activity, and 3) physical activity that is intrinsically enjoyable.
MOVE was delivered during two, 60-75 minute group-based classes and one, 45 minute individualized 1:1 support session to enhance adherence to physical activity recommendations within a lifestyle weight loss program.
The group-based classes included a combination of PowerPoint slides, participant handouts, and group-based discussions.
All MOVE content was delivered by trained study staff.
|
|
Cohort 4
This group of study participants started the 52-week parent randomized controlled trial (NCT03411356) on October 22, 2020.
|
The MOVE physical activity support program is based on the Self-Determination Theory and targets autonomous motivation for physical activity by encouraging 1) choice in physical activity type (e.g.
walking, household chores, yoga), 2) a meaningful, value-based rationale for engaging in physical activity, and 3) physical activity that is intrinsically enjoyable.
MOVE was delivered during two, 60-75 minute group-based classes and one, 45 minute individualized 1:1 support session to enhance adherence to physical activity recommendations within a lifestyle weight loss program.
The group-based classes included a combination of PowerPoint slides, participant handouts, and group-based discussions.
All MOVE content was delivered by trained study staff.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability
Time Frame: weeks 21-30
|
During a 90-minute semi-structured focus group, participants were asked about their satisfaction with major aspects of the MOVE physical activity support program including: 1) MOVE content and 2) delivery of MOVE content including meeting frequency and structure for both group-based and 1:1 meetings.
Participants were also asked about their overall experience with the MOVE program, things that worked well, things that did not work well, and about the most important things they learned from the MOVE program.
|
weeks 21-30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motivation for Physical Activity
Time Frame: weeks 21-30
|
During a 90-minute semi-structured focus group, participants were asked about reasons why they want to be physically activity.
|
weeks 21-30
|
|
Motivation for Sedentary Behavior
Time Frame: weeks 21-30
|
During a 90-minute semi-structured focus group, participants were asked about reasons why they want to be sedentary.
|
weeks 21-30
|
|
Barriers to Physical Activity
Time Frame: weeks 21-30
|
During a 90-minute semi-structured focus group, participants were asked about things that make it harder for them to add more physical activity into their daily lives.
|
weeks 21-30
|
|
Facilitators to Physical Activity
Time Frame: weeks 21-30
|
During a 90-minute semi-structured focus group, participants were asked about things that make it easier for them to add more physical activity into their daily lives.
|
weeks 21-30
|
|
Perceptions of Physical Activity Messages
Time Frame: weeks 21-30
|
During a 90-minute semi-structured focus group, participants were asked about their perception of two different physical activity messages:
|
weeks 21-30
|
|
Influence of Diet on Physical Activity Adherence
Time Frame: weeks 21-30
|
Participants were asked about how their randomization to their diet strategy (either intermittent fasting or daily caloric restriction) impacted their ability to adhere (or not adhere) to physical activity.
|
weeks 21-30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Danielle M Ostendorf, PhD, University of Colorado Anschutz Health and Wellness Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 13, 2019
Primary Completion (Actual)
April 14, 2021
Study Completion (Actual)
April 14, 2021
Study Registration Dates
First Submitted
June 15, 2021
First Submitted That Met QC Criteria
June 15, 2021
First Posted (Actual)
June 23, 2021
Study Record Updates
Last Update Posted (Actual)
June 23, 2021
Last Update Submitted That Met QC Criteria
June 15, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-0826
- F32DK122652 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
Clinical Trials on MOVE
-
VA Office of Research and DevelopmentCompleted
-
VA Office of Research and DevelopmentThe American Legion Department of Wisconsin; Veterans Of Foreign Wars Of The... and other collaboratorsCompletedHypertension | Obesity | Diabetes Mellitus | OverweightUnited States
-
VA Office of Research and DevelopmentCompletedPTSD | Obesity | OverweightUnited States
-
University of MinnesotaMayo ClinicCompletedSit-Stand WorkstationsUnited States
-
Welltory Inc.Not yet recruitingPhysical Activity | Sedentary Lifestyle
-
VA Office of Research and DevelopmentCompletedPsychotic Disorders | Obesity | Health BehaviorsUnited States
-
Center for Disability Services, New YorkRecruitingQuality of Life | Health Care UtilizationUnited States
-
University of PittsburghCenters for Disease Control and PreventionCompletedBody Weight | Physical Activity | Healthy Aging | Health Behavior | Healthy DietUnited States
-
University of NottinghamCompletedPhysical ActivityUnited Kingdom
-
The University of Texas Health Science Center at...National Institute of Mental Health (NIMH)CompletedSchizophreniaUnited States