Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT06445556
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for adult parents/caregivers are:
* 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.
Inclusion criteria for youth are:
* 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
Exclusion Criteria:
Exclusion criteria for adult parents/caregivers are:
* 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.
Exclusion criteria for youth are:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT06445556
Study Brief:
Protocol Section:
NCT06445556