NCT05910671

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 20, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

June 6, 2023

Last Update Submit

June 29, 2023

Conditions

Keywords

Physical ActivityBlackFamiliesIntervention

Outcome Measures

Primary Outcomes (2)

  • change in parent physical activity

    minutes spent in moderate to vigorous physical activity

    week 1 and week 10

  • change in child physical activity

    minutes spent in total physical activity

    week 1 and week 10

Secondary Outcomes (1)

  • change in family physical activity

    week 1 and week 10

Study Arms (2)

Physical Activity Phone Calls and Notebook

EXPERIMENTAL

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 Phone Calls and Notebook

Control

NO INTERVENTION

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.

Interventions

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.

Physical Activity Phone Calls and Notebook

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27858, United States

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Katrina D DuBose, PhD

    East Carolina University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 20, 2023

Study Start

August 1, 2024

Primary Completion

May 1, 2025

Study Completion

August 1, 2025

Last Updated

July 3, 2023

Record last verified: 2023-06

Locations