Parent-Based Physical Activity Intervention for Black Families

Sponsor

East Carolina University (Other)

Overall Status

Suspended

CT.gov ID

NCT05910671

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Physical Inactivity	Behavioral: Physical Activity Behavioral: Physical Activity Notebook with Newsletters	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Parent-Based Physical Activity Intervention for Black Parents and Their Preschool Aged Children

Anticipated Study Start Date :

Aug 1, 2024

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Physical Activity 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.	Behavioral: Physical Activity 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. The behavioral strategies will be discussed weekly for 30 minutes via telephone. Behavioral: Physical Activity Notebook with Newsletters 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 information presented in the physical activity notebook will be discussed weekly during the 30 minute phone calls.
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.
Experimental: Physical Activity Notebook with newsletters As part of the physical activity 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. This information will be discussed weekly during the 30 minute telephone calls.	Behavioral: Physical Activity 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. The behavioral strategies will be discussed weekly for 30 minutes via telephone. Behavioral: Physical Activity Notebook with Newsletters 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 information presented in the physical activity notebook will be discussed weekly during the 30 minute phone calls.

Arm

Intervention/Treatment

Experimental: Physical Activity

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.

Behavioral: Physical Activity

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. The behavioral strategies will be discussed weekly for 30 minutes via telephone.

Behavioral: Physical Activity Notebook with Newsletters

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 information presented in the physical activity notebook will be discussed weekly during the 30 minute phone calls.

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.

Experimental: Physical Activity Notebook with newsletters

As part of the physical activity 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. This information will be discussed weekly during the 30 minute telephone calls.

Behavioral: Physical Activity

Behavioral: Physical Activity Notebook with Newsletters

Outcome Measures

Primary Outcome Measures

change in parent physical activity [week 1 and week 10]
minutes spent in moderate to vigorous physical activity
change in child physical activity [week 1 and week 10]
minutes spent in total physical activity

Secondary Outcome Measures

change in family physical activity [week 1 and week 10]
minutes spent in physical activity spent between parent and child

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Carolina University	Greenville	North Carolina	United States	27858

Sponsors and Collaborators

East Carolina University

Investigators

Principal Investigator: Katrina D DuBose, PhD, East Carolina University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katrina DuBose, Professor, East Carolina University

ClinicalTrials.gov Identifier:

NCT05910671

Other Study ID Numbers:

21-001263

First Posted:

Jun 20, 2023

Last Update Posted:

Jun 20, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Katrina DuBose, Professor, East Carolina University

Study Results

No Results Posted as of Jun 20, 2023