Healthy Children, Strong Families: American Indian Communities Preventing Obesity

Completed · Not applicable

Conditions studied: Obesity, Overweight

In brief

Healthy Children, Strong Families-2 (HCSF-2) is a family focused early childhood intervention which addresses the growing problem of childhood obesity in American Indian communities. The study works with six rural and urban American Indian communities across the US to test the ability of the intervention to increase adoption of healthy lifestyles and to reduce the prevalence of obesity among preschool aged American Indian children and their primary caregivers - creating healthier children, healthier families and healthier communities. Our primary hypothesis is that children and their primary caregivers who receive the HCSF-2 intervention will have better obesity related outcomes than those who do not receive HCSF-2.

Key facts

Study ID

NCT01776255

Run by

University of Wisconsin, Madison

People needed

900

Starts

2013-01-01

Expected to finish

2017-04-27

Last updated by the study team

2017-10-26

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult caregiver with a 2-5 year old child
• 2-5 year old child with a caregiver
• Caregiver has a working cell phone and is willing to receive regular text messages as part of study participation
• Caregiver lives within feasible travel distance of data collection site and willing to come for data collection visits at 0, 6 months, 12 months, 18 months and 24 months
• Willingness to be randomized to one of two groups with the understanding that all participants will receive all components of the intervention, randomization simply determines the order in which materials are received
• Valid mailing address where participant can receive mail and packages
• Basic English fluency and literacy sufficient for understanding the intervention materials and completing questionnaires

You may not qualify if…

• Adults with no children or whose only children are younger than 2 or older than 5
• Children younger than 2 or older than 5 years of age
• No cell phone or unwilling to receive regular text messages as part of study participation
• Lives beyond feasible travel distance of data collection sites AND/OR planning on moving out of the area within a two year period
• Child has major physical or behavioral disorder (e.g. failure to thrive, severe autism) that would seriously impact study participation
• No valid mailing address
• Unwillingness to accept random allocation to study arm
• Spouse/partner of another caregiver-child pair who is living in same home \& who has already enrolled (e.g. only one adult-child pair per household may be enrolled)

Where it is running

• White Earth Child Care Program — White Earth, Minnesota, United States
• Blackfeet Nation — Browning, Montana, United States
• First Nations HealthSource — Albuquerque, New Mexico, United States
• Seneca Nation — Irving, New York, United States
• Menominee Tribe of Wisconsin — Keshena, Wisconsin, United States

Full record on ClinicalTrials.gov

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