- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04505085
Active Dads Healthy Families
July 7, 2022 updated by: Duke University
Active Dads Healthy Families: Promoting Physical Activity and Enhancing Father-child Relationships Through Parks and Recreation
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.
Study Overview
Status
Completed
Conditions
Detailed Description
The investigators will evaluate the feasibility of a community-based father-child physical activity promotion program.
The investigators will work with a local Parks and Recreation department to recruit and deliver programming to three cohorts of fathers and their children 2-5 years old.
To evaluate program feasibility, the investigators will assess recruitment efforts, program attendance, and participant engagement and satisfaction with the program.
The investigators will also assess change in father-child outcomes post program including objectively measured physical activity, fathers' parenting, and father involvement.
Study Type
Interventional
Enrollment (Actual)
24
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
-
-
North Carolina
-
Durham, North Carolina, United States, 27701
- Durham Parks and Recreation
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Father or father figure to child between the ages 2-5 years
- Father or father figure 18+ years
- Can speak and read in English
Exclusion Criteria:
- Father or child has a physical disability precluding them from being physically active
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: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active Dads Healthy Families: Outdoor Education
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.
|
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.
|
|
Experimental: Active Dads Healthy Families: Fitness
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment as measured by number of participants who enroll
Time Frame: Baseline
|
Baseline
|
|
|
Attendance as measured by number of participants present at each session
Time Frame: Baseline through 8 weeks
|
Baseline through 8 weeks
|
|
|
Degree of participation in physical activity during each session
Time Frame: Baseline through 8 weeks
|
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
Time Frame: 8 weeks
|
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
Time Frame: Baseline
|
Baseline
|
|
|
Percent of participants who complete all study measures
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in moderate to vigorous physical activity as measured by accelerometry
Time Frame: Baseline, 8 weeks
|
Child objectively measured physical activity
|
Baseline, 8 weeks
|
|
Change in moderate to vigorous physical activity as measured by accelerometry
Time Frame: Baseline, 8 weeks
|
Father objectively measured physical activity
|
Baseline, 8 weeks
|
|
Change in father support for child physical activity as measured by father self-report
Time Frame: Baseline, 8 weeks
|
15-item engagement subscale score from the Preschool Physical Activity Parenting Practices instrument, scored by calculating mean of items (range 1-5), higher scores indicate greater parent engagement
|
Baseline, 8 weeks
|
|
Change in father physical activity psychological control as measured by father self-report
Time Frame: Baseline, 8 weeks
|
5-item psychological control subscale score from the Preschool Physical Activity Parenting Practices instrument, scored by calculating mean of items (range 1-5), higher scores indicate greater parent psychological control
|
Baseline, 8 weeks
|
|
Change in father involvement in physical play as measured by father self-report
Time Frame: Baseline, 8 weeks
|
9-item scale about father involvement in physical play, scored by calculating the mean of all items (range 1-6), with higher scores indicating greater father involvement
|
Baseline, 8 weeks
|
|
Change in father involvement in care-giving as measured by father self-report
Time Frame: Baseline, 8 weeks
|
13-item scale about father involvement in care-giving, scored by calculating the mean of all items (range 1-6), with higher scores indicate greater father involvement
|
Baseline, 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sarah C Armstrong, MD, Duke 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 (Actual)
April 17, 2021
Primary Completion (Actual)
November 5, 2021
Study Completion (Actual)
November 5, 2021
Study Registration Dates
First Submitted
July 30, 2020
First Submitted That Met QC Criteria
August 6, 2020
First Posted (Actual)
August 7, 2020
Study Record Updates
Last Update Posted (Actual)
July 11, 2022
Last Update Submitted That Met QC Criteria
July 7, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00106052
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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