NCT06445556

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2024

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

May 20, 2024

Last Update Submit

January 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Secondary Outcomes (2)

  • Pre-/post-intervention changes in psychological health

    12 weeks

  • Pre-/post-intervention changes in blood pressure

    12 weeks

Study Arms (2)

NatureUplift

ACTIVE COMPARATOR

Parent-child dyads randomized to NatureUplift group

Behavioral: NatureUplift

NatureUplift+Active

EXPERIMENTAL

Parent-child dyads randomized to NatureUplift+Active group

Behavioral: NatureUplift+Active

Interventions

NatureUpliftBEHAVIORAL

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

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.

NatureUplift+Active

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

  • Junia de Brito, PhD, MPH, MBA

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This pilot study is a two-arm, parallel randomized controlled trial. 12-16 parent-child dyads will be recruited
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2024

First Posted

June 6, 2024

Study Start

May 15, 2024

Primary Completion

December 14, 2024

Study Completion

December 14, 2024

Last Updated

January 8, 2025

Record last verified: 2025-01

Locations