Parent-Based Physical Activity Intervention for Black Families

Physical Inactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05910671
• Other study ID #: 21-001263
• Status: Suspended
• Phase: N/A
• Start date: August 2024
• Est. completion date: August 2025

Study information

• Verified date: June 2023
• Source: East Carolina University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 52
• Est. completion date: August 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Inactivity

Intervention

Behavioral:
• Physical Activity Phone Calls and Notebook
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.

Locations

Country	Name	City	State
United States	East Carolina University	Greenville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
East Carolina University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in parent physical activity	minutes spent in moderate to vigorous physical activity	week 1 and week 10
Primary	change in child physical activity	minutes spent in total physical activity	week 1 and week 10
Secondary	change in family physical activity	minutes spent in physical activity spent between parent and child	week 1 and week 10