Physical InactivityNCT05910671
Parent-Based Physical Activity Intervention for Black Families
A study testing Physical Activity Phone Calls and Notebook in people with Physical Inactivity, run by East Carolina University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Physical Activity Phone Calls and Notebook
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2024to Aug 2025
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 27858
About this study
Official title: Parent-Based Physical Activity Intervention for Black Parents and Their Preschool Aged Children
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.
Read the detailed description
This research will examine how preschool-aged children's physical activity levels will be affected based off an intervention that encourages physical activity engagement between parents and children. A secondary purpose is to determine if the intervention impacts the children's body mass index. Black parents with a child between the ages of 2-5 will be recruited to participate in the study. Before the intervention begins, parents will complete questionnaires on demographics, health history, physical activity knowledge, family physical activity, and parenting styles. Then both parents and children will have weight, height, resting heart rate and blood pressure measured. Finally, the parents and children will be given physical activity monitors to wear for 7 days. After wearing the activity monitors the dyads will be randomized into either a control or intervention group. The control group will continue with their normal activities for 8 weeks. Those in the intervention group will receive weekly newsletters and a 30-min/week telephone call with an activity coach over 8 weeks. The newsletters and phone calls will discuss information related to physical activity change. After the 8-week time period, all parent-child dyads will complete the same questionnaires and measurements and wear the activity monitors again.
- Conditions
- Physical Inactivity
- Being tested
- Physical Activity Phone Calls and Notebook
- Keywords
- Physical Activity, Black, Families, Intervention
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Phone Calls and NotebookBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in parent physical activity
minutes spent in moderate to vigorous physical activity
Measured: week 1 and week 10
change in child physical activity
minutes spent in total physical activity
Measured: week 1 and week 10
Secondary outcomes (1)
change in family physical activity
minutes spent in physical activity spent between parent and child
Measured: week 1 and week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study startAug 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Why it stopped: unable to recruit participants due to COVID affective the target population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrina DuBose, East Carolina University
- Investigators
- Katrina D DuBose, PhD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910671
- Sponsor's protocol ID
- 21-001263
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-Based Physical Activity Intervention for Black Parents and Their Preschool Aged Children
- ClinicalTrials.gov ID
- NCT05910671
- Acronym / sponsor ID
- 21-001263
- Conditions
- Physical Inactivity
- Keywords
- Physical Activity, Black, Families, Intervention
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: unable to recruit participants due to COVID affective the target population
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 20 Jun 2023 (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.
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.
Detailed description
This research will examine how preschool-aged children's physical activity levels will be affected based off an intervention that encourages physical activity engagement between parents and children. A secondary purpose is to determine if the intervention impacts the children's body mass index. Black parents with a child between the ages of 2-5 will be recruited to participate in the study. Before the intervention begins, parents will complete questionnaires on demographics, health history, physical activity knowledge, family physical activity, and parenting styles. Then both parents and children will have weight, height, resting heart rate and blood pressure measured. Finally, the parents and children will be given physical activity monitors to wear for 7 days. After wearing the activity monitors the dyads will be randomized into either a control or intervention group. The control group will continue with their normal activities for 8 weeks. Those in the intervention group will receive weekly newsletters and a 30-min/week telephone call with an activity coach over 8 weeks. The newsletters and phone calls will discuss information related to physical activity change. After the 8-week time period, all parent-child dyads will complete the same questionnaires and measurements and wear the activity monitors again.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Phone Calls and Notebook | Experimental | Behavioral: Physical Activity Phone Calls and NotebookThe 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. |
| 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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Physical Activity Phone Calls and NotebookThis 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. | Behavioural | Physical Activity Phone Calls and Notebook |
Primary outcome
change in parent physical activity
Time frame: week 1 and week 10
minutes spent in moderate to vigorous physical activity
change in child physical activity
Time frame: week 1 and week 10
minutes spent in total physical activity
1 secondary outcome
change in family physical activity
Time frame: week 1 and week 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
Related trials for Physical Inactivity
Enrolling by invitation
Recreational Badminton, Sleep and Melatonin
Sedentary Behavior
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
Not yet recruiting
Wearable Ankle Power Training (WearAPT) for Enhanced Mobility in Aging
Sedentary Behavior / Physical Inactivity, Aged
Active, not recruiting
Promoting Physical Activity in Older Hispanic/Latino(a) Adults
Sedentary Behavior, Physical Inactivity
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.
Katrina D DuBose, PhD principal investigator
East Carolina 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 Physical Activity Phone Calls and Notebook in people with Physical Inactivity, run by East Carolina 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 4 inclusion and 4 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: paused, as of the sponsor's last update on 3 Jul 2023. 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?
Results are not available in the source record.
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?
change in parent physical activity (time frame: week 1 and week 10). The study lists 2 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 3 Jul 2023.