HealthyNCT06445556
Uplifting Equitable Park Use and Promoting Physical Activity Among African American Families in Minnesota: A Culturally-Responsive, Community-Engaged Approach
A study testing NatureUplift and NatureUplift+Active in people with Healthy, run by University of Minnesota at 1 site in United States.
Trial summary
Social injustices, such as the absence of racial representation and culturally tailored programs in parks, may further discourage African American families from accessing and using these spaces. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NatureUplift and NatureUplift+Active
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 14 Dec 2024
- 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Able and willing to provide informed consent for child
- Are the child's primary caregiver, i.e., they are the adult who spends the largest proportion of time caring for the child (e.g., cleaning, feeding, etc.) or they spent an exactly equal proportion to another caregiver (e.g., parents each with 50% of childcare responsibilities)
- Are able to read and speak English
- Self-reported Black/African American
- Live in the Twin Cities area
- Participating in less than 60 min/day and 150 min/week of PA, assessed via a modified a Godin-Shephard Leisure Time Physical Activity Questionnaire
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- No contraindications to engaging in PA, assessed via the Physical Activity Readiness Questionnaire (PAR-Q+)
- Parents need to own a smartphone or a tablet to synchronize both their Fitbit and their children's Fitbit with the Fitbit application.
- Able and willing to provide informed assent and to comply with study requirements
- Child aged 8-12 years
- Live with the consenting parent/caregiver at least 50% of the time
- Are able to read and speak English
Who cannot join
- Currently engaged in ≥150 min/week of PA.
- Individuals with contraindications to exercise participation as indicated by the PAR-Q+.
- A self-reported physical/mental disability that would prevent them from being able to adhere to the intervention.
- Currently pregnant or planning to become pregnant during the study period.
- Currently breastfeeding.
- Unwilling to be randomized to a study group.
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- Currently engaged in >60 min of MVPA per day
- Individuals with contraindications to exercise participation as indicated by the PAR-Q+.
- Evidence of significant cognitive deficits or a severe, persistent psychiatric disorder (self-reported by the caregiver) that may interfere with comprehension of survey and adhere to the intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Social injustices, such as the absence of racial representation and culturally tailored programs in parks, may further discourage African American families from accessing and using these spaces. 10 Studies are needed to investigate how exposure to more equitable greenspace environments may support physical activity (PA) among African American families. Justice-focused, park-based PA interventions hold high promise for reducing health disparities and future cardiovascular diseases (CVD) and related chronic conditions (RCC) risk, thus carrying significant implications for the fields of public health, family medicine, and urban planning.
This pilot study is a two-arm, parallel randomized controlled trial that will be conducted in partnership with community stakeholders from the Three River Park District (TRPD); TRPD parks are located in the Twin Cities region of Minnesota. This trial aims to evaluate the changes in PA, psychological health, sleep, and blood pressure among a cohort of African American parent-child dyads who will be randomized to two intervention conditions. The intervention conditions are: (1) a culturally tailored, nature-based program offered at the TRPD (hereafter, "NatureUplift"), and (2) NatureUplift plus a supplementary walking/hiking educational component (hereafter, "NatureUplift+Active"). Participant dyads will be randomized to NatureUplift or NatureUplift+Active.
- Conditions
- Healthy
- Being tested
- NatureUplift, NatureUplift+Active
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatureUpliftBehavioural
a culturally tailored, nature-based program offered at the TRPD. treatment condition will have a duration of 12 weeks, with 60 min/week of nature-based, light-intensity activities (e.g., forest bathing). Following week 12, participant dyads who were randomized to the NatureUplift intervention (i.e., delayed intervention arm) will receive access to 4 additional weeks of the NatureUplift+Active intervention.
NatureUplift+ActiveBehavioural
NatureUplift plus a supplementary walking/hiking educational component. treatment condition will have a duration of 12 weeks, with 60 min/week of nature-based, light-intensity activities (e.g., forest bathing) prescribed during the NatureUplift condition and an additional 60 min/week of supplementary moderate- intensity activities (e.g., walking and hiking) prescribed during the NatureUplift+Active condition. Those who were randomized to the NatureUplift+Active intervention will continue to receive access to 4 additional weeks of the NatureUplift+Active intervention.
| Study group | Role | What they receive |
|---|---|---|
| NatureUplift | Active comparator | Parent-child dyads randomized to NatureUplift group Receives: Behavioral: NatureUplift |
| NatureUplift+Active | Experimental | Parent-child dyads randomized to NatureUplift+Active group Receives: Behavioral: NatureUplift+Active |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-/post-intervention changes in physical activity (PA)
ActiGraph GT9X will be used to measure primary outcomes (time spent in light- (LPA), moderate- (MPA), and vigorous-intensity (VPA)) Fitbits are also used, but mostly to monitor compliance and not necessarily to report on the outcome.
Measured: 12 weeks
Secondary outcomes (2)
Pre-/post-intervention changes in psychological health
assessed among child and adult participants using self-report measures, including survey items assessing for (1) perceived stress, (2) mood and affect, (3) anxiety symptoms, and (4) depressive symptoms.
Measured: 12 weeks
Pre-/post-intervention changes in blood pressure
Pre/Post-intervention changes in blood pressure assessed among child and adult participants using a digital blood pressure monitor
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start15 May 2024
- Primary completion14 Dec 2024
- Study completion14 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This pilot study is a two-arm, parallel randomized controlled trial. 12-16 parent-child dyads will be recruited
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junia de Brito, PhD, MPH, MBA, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445556
- Sponsor's protocol ID
- MED-2024-32932
- Status last verified
- Jan 2025
- First submitted
- 20 May 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uplifting Equitable Park Use and Promoting Physical Activity Among African American Families in Minnesota: A Culturally-Responsive, Community-Engaged Approach
- ClinicalTrials.gov ID
- NCT06445556
- Acronym / sponsor ID
- MED-2024-32932
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 14 Dec 2024 (actual)
- Study completion
- 14 Dec 2024 (actual)
- First posted
- 6 Jun 2024 (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.
Social injustices, such as the absence of racial representation and culturally tailored programs in parks, may further discourage African American families from accessing and using these spaces. 10 Studies are needed to investigate how exposure to more equitable greenspace environments may support physical activity (PA) among African American families. Justice-focused, park-based PA interventions hold high promise for reducing health disparities and future cardiovascular diseases (CVD) and related chronic conditions (RCC) risk, thus carrying significant implications for the fields of public health, family medicine, and urban planning.
This pilot study is a two-arm, parallel randomized controlled trial that will be conducted in partnership with community stakeholders from the Three River Park District (TRPD); TRPD parks are located in the Twin Cities region of Minnesota. This trial aims to evaluate the changes in PA, psychological health, sleep, and blood pressure among a cohort of African American parent-child dyads who will be randomized to two intervention conditions. The intervention conditions are: (1) a culturally tailored, nature-based program offered at the TRPD (hereafter, "NatureUplift"), and (2) NatureUplift plus a supplementary walking/hiking educational component (hereafter, "NatureUplift+Active"). Participant dyads will be randomized to NatureUplift or NatureUplift+Active.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This pilot study is a two-arm, parallel randomized controlled trial. 12-16 parent-child dyads will be recruited
| Arm | Type | Receives |
|---|---|---|
| NatureUplift | Active comparator | Behavioral: NatureUpliftParent-child dyads randomized to NatureUplift group |
| NatureUplift+Active | Experimental | Behavioral: NatureUplift+ActiveParent-child dyads randomized to NatureUplift+Active group |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Able and willing to provide informed consent for child
- Are the child's primary caregiver, i.e., they are the adult who spends the largest proportion of time caring for the child (e.g., cleaning, feeding, etc.) or they spent an exactly equal proportion to another caregiver (e.g., parents each with 50% of childcare responsibilities)
- Are able to read and speak English
- Self-reported Black/African American
- Live in the Twin Cities area
Key exclusion criteria (9 listed)
- Currently engaged in ≥150 min/week of PA.
- Individuals with contraindications to exercise participation as indicated by the PAR-Q+.
- A self-reported physical/mental disability that would prevent them from being able to adhere to the intervention.
- Currently pregnant or planning to become pregnant during the study period.
- Currently breastfeeding.
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 |
|---|---|---|
| NatureUplifta culturally tailored, nature-based program offered at the TRPD. treatment condition will have a duration of 12 weeks, with 60 min/week of nature-based, light-intensity activities (e.g., forest bathing). Following week 12, participant dyads who were randomized to the NatureUplift intervention (i.e., delayed intervention arm) will receive access to 4 additional weeks of the NatureUplift+Active intervention. | Behavioural | NatureUplift |
| NatureUplift+ActiveNatureUplift plus a supplementary walking/hiking educational component. treatment condition will have a duration of 12 weeks, with 60 min/week of nature-based, light-intensity activities (e.g., forest bathing) prescribed during the NatureUplift condition and an additional 60 min/week of supplementary moderate- intensity activities (e.g., walking and hiking) prescribed during the NatureUplift+Active condition. Those who were randomized to the NatureUplift+Active intervention will continue to receive access to 4 additional weeks of the NatureUplift+Active intervention. | Behavioural | NatureUplift+Active |
Primary outcome
Pre-/post-intervention changes in physical activity (PA)
Time frame: 12 weeks
ActiGraph GT9X will be used to measure primary outcomes (time spent in light- (LPA), moderate- (MPA), and vigorous-intensity (VPA)) Fitbits are also used, but mostly to monitor compliance and not necessarily to report on the outcome.
2 secondary outcomes
Pre-/post-intervention changes in psychological health
Time frame: 12 weeks
Pre-/post-intervention changes in blood pressure
Time frame: 12 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 8 Jan 2025.
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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.
Junia de Brito, PhD, MPH, MBA principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NatureUplift and NatureUplift+Active in people with Healthy, run by University of Minnesota 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 12 inclusion and 9 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 8 Jan 2025. 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?
Pre-/post-intervention changes in physical activity (PA) (time frame: 12 weeks). 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 8 Jan 2025.