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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04937205
Other study ID # 19-0826
Secondary ID F32DK122652
Status Completed
Phase
First received
Last updated
Start date February 13, 2019
Est. completion date April 14, 2021

Study information

Verified date June 2021
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date April 14, 2021
Est. primary completion date April 14, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Colorado Anschutz Medical Campus Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. weeks 21-30
Secondary Motivation for Physical Activity During a 90-minute semi-structured focus group, participants were asked about reasons why they want to be physically activity. weeks 21-30
Secondary Motivation for Sedentary Behavior During a 90-minute semi-structured focus group, participants were asked about reasons why they want to be sedentary. weeks 21-30
Secondary 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. weeks 21-30
Secondary 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. weeks 21-30
Secondary 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."
weeks 21-30
Secondary 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. weeks 21-30
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