Health BehaviorNCT04505085
Active Dads Healthy Families
A study testing Active Dads Healthy Families: Outdoor Education and Active Dads Healthy Families: Fitness in people with Health Behavior, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Active Dads Healthy Families: Outdoor Education and Active Dads Healthy Families: Fitness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2021to 5 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Father or father figure to child between the ages 2-5 years
- Father or father figure 18+ years
- Can speak and read in English
Who cannot join
- Father or child has a physical disability precluding them from being physically active
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham Parks and Recreation
Durham, North Carolina, 27701
About this study
Official title: 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.
Read the 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.
- Conditions
- Health Behavior
- Being tested
- Active Dads Healthy Families: Outdoor Education, Active Dads Healthy Families: Fitness
- Keywords
- physical activity, parenting, exercise, family-based, father
- Medical subject headings
- Health Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Dads Healthy Families: Outdoor EducationBehavioural
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: FitnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Active Dads Healthy Families: Fitness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment as measured by number of participants who enroll
Measured: Baseline
Attendance as measured by number of participants present at each session
Measured: 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"
Measured: 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"
Measured: 8 weeks
Percent of participants who complete all study measures
Measured: Baseline
Percent of participants who complete all study measures
Measured: 8 weeks
Secondary outcomes (6)
Change in moderate to vigorous physical activity as measured by accelerometry
Child objectively measured physical activity
Measured: Baseline, 8 weeks
Change in moderate to vigorous physical activity as measured by accelerometry
Father objectively measured physical activity
Measured: Baseline, 8 weeks
Change in father support for child physical activity as measured by father self-report
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
Measured: Baseline, 8 weeks
Change in father physical activity psychological control as measured by father self-report
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
Measured: Baseline, 8 weeks
Change in father involvement in physical play as measured by father self-report
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
Measured: Baseline, 8 weeks
Change in father involvement in care-giving as measured by father self-report
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
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start17 Apr 2021
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah C Armstrong, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505085
- Sponsor's protocol ID
- Pro00106052
- Status last verified
- Jul 2022
- First submitted
- 30 Jul 2020
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Dads Healthy Families: Promoting Physical Activity and Enhancing Father-child Relationships Through Parks and Recreation
- ClinicalTrials.gov ID
- NCT04505085
- Acronym / sponsor ID
- Pro00106052
- Conditions
- Health Behavior
- Keywords
- physical activity, parenting, exercise, family-based, father
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 17 Apr 2021 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Dads Healthy Families: Outdoor Education | Experimental | Behavioral: Active Dads Healthy Families: Outdoor EducationThe 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: Fitness | Experimental | Behavioral: Active Dads Healthy Families: FitnessThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Father or father figure to child between the ages 2-5 years
- Father or father figure 18+ years
- Can speak and read in English
Key exclusion criteria (1 listed)
- Father or child has a physical disability precluding them from being physically active
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Dads Healthy Families: Outdoor EducationThe 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. | Behavioural | Active Dads Healthy Families: Outdoor Education |
| Active Dads Healthy Families: FitnessThe 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. | Behavioural | Active Dads Healthy Families: Fitness |
Primary outcome
Recruitment as measured by number of participants who enroll
Time frame: Baseline
Attendance as measured by number of participants present at each session
Time frame: 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"
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"
Percent of participants who complete all study measures
Time frame: Baseline
Percent of participants who complete all study measures
Time frame: 8 weeks
6 secondary outcomes
Change in moderate to vigorous physical activity as measured by accelerometry
Time frame: Baseline, 8 weeks
Change in moderate to vigorous physical activity as measured by accelerometry
Time frame: Baseline, 8 weeks
Change in father support for child physical activity as measured by father self-report
Time frame: Baseline, 8 weeks
Change in father physical activity psychological control as measured by father self-report
Time frame: Baseline, 8 weeks
Change in father involvement in physical play as measured by father self-report
Time frame: Baseline, 8 weeks
Change in father involvement in care-giving as measured by father self-report
Time frame: Baseline, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah C Armstrong, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Dads Healthy Families: Outdoor Education and Active Dads Healthy Families: Fitness in people with Health Behavior, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment as measured by number of participants who enroll (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.