ObesityMOVENCT04937205
Motivation for Exercise and Physical Activity Adherence
An observational study of Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- MOVE
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2019to 14 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- MOVE
- Keywords
- Physical activity, Motivation, Exercise
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2 | This group of study participants started the 52-week parent randomized controlled trial (NCT03411356) on February 13, 2019. Receives: Behavioral: MOVE | |
| Cohort 3 | This group of study participants started the 52-week parent randomized controlled trial (NCT03411356) on November 5, 2019. Receives: Behavioral: MOVE | |
| Cohort 4 | This group of study participants started the 52-week parent randomized controlled trial (NCT03411356) on October 22, 2020. Receives: Behavioral: MOVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
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.
Measured: weeks 21-30
Secondary outcomes (6)
Motivation for Physical Activity
During a 90-minute semi-structured focus group, participants were asked about reasons why they want to be physically activity.
Measured: weeks 21-30
Motivation for Sedentary Behavior
During a 90-minute semi-structured focus group, participants were asked about reasons why they want to be sedentary.
Measured: weeks 21-30
Barriers to Physical Activity
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.
Measured: weeks 21-30
Facilitators to Physical Activity
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.
Measured: weeks 21-30
Perceptions of Physical Activity Messages
During a 90-minute semi-structured focus group, participants were asked about their perception of two different physical activity messages:
- "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."
- "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."
Measured: weeks 21-30
Influence of Diet on Physical Activity Adherence
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.
Measured: weeks 21-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start13 Feb 2019
- Primary completion14 Apr 2021
- Study completion14 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle M Ostendorf, PhD, Principal investigator, University of Colorado Anschutz Health and Wellness Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937205
- Sponsor's protocol ID
- 19-0826
- Other IDs
- F32DK122652
- Acronym
- MOVE
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Motivation for Exercise to Enhance Physical Activity Adherence in Adults With Obesity
- ClinicalTrials.gov ID
- NCT04937205
- Acronym / sponsor ID
- MOVE / 19-0826
- Conditions
- Obesity
- Keywords
- Physical activity, Motivation, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 14 Apr 2021 (actual)
- Study completion
- 14 Apr 2021 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 2 | – | Behavioral: MOVEThis group of study participants started the 52-week parent randomized controlled trial (NCT03411356) on February 13, 2019. |
| Cohort 3 | – | Behavioral: MOVEThis group of study participants started the 52-week parent randomized controlled trial (NCT03411356) on November 5, 2019. |
| Cohort 4 | – | Behavioral: MOVEThis group of study participants started the 52-week parent randomized controlled trial (NCT03411356) on October 22, 2020. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOVEThe 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. | Behavioural | Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
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.
6 secondary outcomes
Motivation for Physical Activity
Time frame: weeks 21-30
Motivation for Sedentary Behavior
Time frame: weeks 21-30
Barriers to Physical Activity
Time frame: weeks 21-30
Facilitators to Physical Activity
Time frame: weeks 21-30
Perceptions of Physical Activity Messages
Time frame: weeks 21-30
Influence of Diet on Physical Activity Adherence
Time frame: weeks 21-30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle M Ostendorf, PhD principal investigator
University of Colorado Anschutz Health and Wellness Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: weeks 21-30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.