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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort 2
This group of study participants started the 52-week parent randomized controlled trial (NCT03411356) on February 13, 2019.
Behavioral: MOVE
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.
Behavioral: MOVE
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.
Behavioral: MOVE
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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:

  1. "For substantial health benefits, adults should do at least 150 minutes (2 hours and 30 minutes) to 300 minutes (5 hours) a week of moderate-intensity, or 75 minutes (1 hour and 15 minutes) to 150 minutes (2 hours and 30 minutes) a week of vigorous-intensity aerobic physical activity, or an equivalent combination of moderate- and vigorous-intensity aerobic activity. Preferably, aerobic activity should be spread throughout the week."
  2. "Move in ways that make you feel good. Benefits of physical activity include improved mood, sleep, less anxiety, more patience. All movement counts. Find opportunities to move throughout the day."
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 14, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 14, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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