- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05910671
Parent-Based Physical Activity Intervention for Black Families
June 29, 2023 updated by: Katrina DuBose, East Carolina University
Parent-Based Physical Activity Intervention for Black Parents and Their Preschool Aged Children
This study is an 8-week parent-based physical activity intervention focusing on increasing physical activity in preschool-aged children.
The participants will be randomized into two groups: control and intervention.
During the 8 weeks those in the intervention group will receive weekly newsletters and have weekly phone calls with a physical activity coach.
The material in weekly newsletters and focus of the phone calls will be on behavior changes related to physical activity.
Parents will be encouraged to complete physical activity alone and with their child.
The control group will not have any contact with study staff during the 8-week intervention and continue with normal behaviors.
Physical activity levels in the parents and children will be measures before and after the intervention.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Detailed Description
This research will examine how preschool-aged children's physical activity levels will be affected based off an intervention that encourages physical activity engagement between parents and children.
A secondary purpose is to determine if the intervention impacts the children's body mass index.
Black parents with a child between the ages of 2-5 will be recruited to participate in the study.
Before the intervention begins, parents will complete questionnaires on demographics, health history, physical activity knowledge, family physical activity, and parenting styles.
Then both parents and children will have weight, height, resting heart rate and blood pressure measured.
Finally, the parents and children will be given physical activity monitors to wear for 7 days.
After wearing the activity monitors the dyads will be randomized into either a control or intervention group.
The control group will continue with their normal activities for 8 weeks.
Those in the intervention group will receive weekly newsletters and a 30-min/week telephone call with an activity coach over 8 weeks.
The newsletters and phone calls will discuss information related to physical activity change.
After the 8-week time period, all parent-child dyads will complete the same questionnaires and measurements and wear the activity monitors again.
Study Type
Interventional
Enrollment (Estimated)
52
Phase
- Not Applicable
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
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North Carolina
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Greenville, North Carolina, United States, 27858
- East Carolina University
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- adults who are 19 years old or older
- adult has a child who is between 2-5 years old
- child must be living with the parent
- parent identifies as Black/African American
Exclusion Criteria:
- parent is currently meeting physical activity recommendations
- parent is currently pregnant or < 6 weeks post-pregnancy
- child has condition that restricts physical activity
- parent is unable to speak or write in English
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
During the 8 weeks the participants in the control group will neither receive the intervention material nor have any contact with physical activity coaches.
They will continue interacting with their young child as normal.
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|
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Experimental: Physical Activity Phone Calls and Notebook
The intervention will last 8 weeks.
As part of the intervention the participants (parents) will receive a notebook with weekly newsletters that discuss behavioral strategies for physical activity changes, note pages, listing of local parks, and age-appropriate physical activities that parents and young children can do together.
The intervention group will also have individual weekly telephone meetings with a physical activity coach.
The weekly meeting is expected to last approximately 30 minutes.
During this meeting, participants will discuss that week's behavioral strategy to promote physical activity, report on the past week's physical activity goals, failures and successes, and set goals for the next week.
Each week parents will be asked to set a goal to be physically active with their child and a goal to be physically active alone.
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This intervention encouraged parents to model physical activity behaviors and co-participate in physical activity with their young child.
Each week behavioral strategies for promoting physical activity change will be discussed to help parents work towards meeting their activity goals.
As part of the physical activity intervention parents will receive a physical activity notebook that has newsletters, suggested activities that can be done with their child, and other material that will help the parent and child be active active together.
The behavioral strategies and the information in the notebook will will be discussed weekly for 30 minutes via telephone.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in parent physical activity
Time Frame: week 1 and week 10
|
minutes spent in moderate to vigorous physical activity
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week 1 and week 10
|
|
change in child physical activity
Time Frame: week 1 and week 10
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minutes spent in total physical activity
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week 1 and week 10
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in family physical activity
Time Frame: week 1 and week 10
|
minutes spent in physical activity spent between parent and child
|
week 1 and week 10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Katrina D DuBose, PhD, East Carolina University
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 (Estimated)
August 1, 2024
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
June 6, 2023
First Submitted That Met QC Criteria
June 15, 2023
First Posted (Actual)
June 20, 2023
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 29, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 21-001263
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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