NCT04505085

Brief Summary

The purpose of this study is to evaluate the feasibility of implementing a community-delivered physical activity program for fathers and their children ages 2-5 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 30, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

April 17, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2021

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

July 30, 2020

Last Update Submit

July 7, 2022

Conditions

Keywords

physical activityparentingexercisefamily-basedfather

Outcome Measures

Primary Outcomes (6)

  • Recruitment as measured by number of participants who enroll

    Baseline

  • Attendance as measured by number of participants present at each session

    Baseline through 8 weeks

  • Degree of participation in physical activity during each session

    As measured by observation using the System for Observing Fitness Instruction Time (SOFIT) instrument, activity scores range from 1 "lying down" to 5 "vigorous"

    Baseline through 8 weeks

  • Percent of participants satisfied with the program as measured by self-report evaluation survey

    Self-report program evaluation survey; 13 items with responses ranging from 1 "strongly disagree" to 5 "strongly agree"

    8 weeks

  • Percent of participants who complete all study measures

    Baseline

  • Percent of participants who complete all study measures

    8 weeks

Secondary Outcomes (6)

  • Change in moderate to vigorous physical activity as measured by accelerometry

    Baseline, 8 weeks

  • Change in moderate to vigorous physical activity as measured by accelerometry

    Baseline, 8 weeks

  • Change in father support for child physical activity as measured by father self-report

    Baseline, 8 weeks

  • Change in father physical activity psychological control as measured by father self-report

    Baseline, 8 weeks

  • Change in father involvement in physical play as measured by father self-report

    Baseline, 8 weeks

  • +1 more secondary outcomes

Study Arms (2)

Active Dads Healthy Families: Outdoor Education

EXPERIMENTAL

The intervention will include outdoor education and physical activity opportunities at various outdoor parks. The program will be held one day a week for eight consecutive weeks. Parks and Recreation will facilitate and run the program. Each session will last 60 minutes and include a brief educational discussion and opportunities for various games and activities. Each session will have a special theme relevant to the outdoors. Families will also receive a home toolbox to facilitate activity and learning outside of the program. Feedback on physical activity will be provided at the beginning and the end of the program.

Behavioral: Active Dads Healthy Families: Outdoor Education

Active Dads Healthy Families: Fitness

EXPERIMENTAL

The intervention will include physical activity opportunities at a community center. The program will be held one day a week for eight consecutive weeks. Parks and Recreation will facilitate and run the program. Each session will last 60 minutes and include a brief educational discussion and opportunities for various games and activities. Families will also receive a home toolbox to facilitate activity outside of the program. Feedback on physical activity will be provided at the beginning and the end of the program.

Behavioral: Active Dads Healthy Families: Fitness

Interventions

The intervention will include outdoor education and physical activity opportunities at various outdoor parks. The program will be held one day a week for eight consecutive weeks. Parks and Recreation will facilitate and run the program. Each session will last 60 minutes and include a brief educational discussion and opportunities for various games and activities. Each session will have a special theme relevant to the outdoors. Families will also receive a home toolbox to facilitate activity and learning outside of the program. Feedback on physical activity will be provided at the beginning and the end of the program.

Active Dads Healthy Families: Outdoor Education

The intervention will include physical activity opportunities at a community center. The program will be held one day a week for eight consecutive weeks. Parks and Recreation will facilitate and run the program. Each session will last 60 minutes and include a brief educational discussion and opportunities for various games and activities. Families will also receive a home toolbox to facilitate activity outside of the program. Feedback on physical activity will be provided at the beginning and the end of the program.

Active Dads Healthy Families: Fitness

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Father or father figure to child between the ages 2-5 years
  • Father or father figure 18+ years
  • Can speak and read in English

You may not qualify if:

  • Father or child has a physical disability precluding them from being physically active

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham Parks and Recreation

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Health BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sarah C Armstrong, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A non-randomized quasi-experimental design will be used to evaluate the feasibility of the Active Dads Healthy Families intervention, and provide preliminary data of changes over time and between two forms of the intervention. The investigators will recruit two cohorts totaling 30 father-child dyads (15 per cohort) to take part in the 8-week program delivered by Parks and Recreation. The primary outcome is program feasibility.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 7, 2020

Study Start

April 17, 2021

Primary Completion

November 5, 2021

Study Completion

November 5, 2021

Last Updated

July 11, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations