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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 5, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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