Healthy Children, Strong Families: American Indian Communities Preventing Obesity (HCSF2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01776255
First received: January 16, 2013
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Obesity
Overweight
Behavioral: Healthy Children, Strong Families
Behavioral: Child Safety

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Healthy Children, Strong Families: American Indian Communities Preventing Obesity

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Change in child adiposity from baseline measured via BMI z-score [ Time Frame: Enrollment, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
    BMI z-score is obtained by computing the BMI weight (in kg)/height (in m)*height (in m). BMI is then converted to a z-score based on US national norms for gender and age in months provided

  • Change in adult adiposity from baseline measured via BMI [ Time Frame: Enrollment, 12 months, 24 months ] [ Designated as safety issue: No ]
    Adult BMI is computed from weight (in kg) divided by height (in m) squared


Secondary Outcome Measures:
  • Change in child adiposity from baseline measured via waist circumference [ Time Frame: Enrollment, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
    Waist circumference (in cm) is measured with a plastic measuring tape

  • Change in adult adiposity from baseline measured via waist circumference [ Time Frame: Enrollment, 12 months, 24 months ] [ Designated as safety issue: No ]
    Waist circumference (in cm) is measured with a plastic measuring tape

  • Change in child fruit and vegetable consumption from baseline [ Time Frame: Enrollment, 12 months, 24 months ] [ Designated as safety issue: No ]
    Child fruit and vegetable consumption measured via a 13-item questionnaire completed by the primary caregiver that is based on questions contained in the 2010 National Youth Physical Activity and Nutrition Survey published by the Centers for Disease Control and Prevention

  • Change in adult fruit and vegetable consumption from basline [ Time Frame: Enrollment, 12 months, 24 months ] [ Designated as safety issue: No ]
    Adult fruit and vegetable consumption is measured with a 30-item questionnaire published by the National Cancer Institute.

  • Change in amount of child screen time from basline [ Time Frame: Enrollment, 12 month, 24 month ] [ Designated as safety issue: No ]
    Amount of time spent watching TV, videos, video games, and computer are assessed via 8 items on a questionnaire completed by primary caregiver.

  • Change in amount of adult screen time from basline [ Time Frame: Enrollment, 12 month, 24 month ] [ Designated as safety issue: No ]
    Amount of time spent watching TV, videos, video games, and computer are assessed via 8 items on a questionnaire.

  • Change in amount of child physical activity from baseline [ Time Frame: Enrollment, 12 months, 24 months ] [ Designated as safety issue: No ]
    Child physical activity is measured via primary caregiver's responses to the 8 items on the Netherlands Physical Activity Questionnaire.

  • Change in amount of adult physical activity from basline [ Time Frame: Enrollment, 12 months, 24 months ] [ Designated as safety issue: No ]
    Adult physical activity is measured via the 4 item Godin physical activity questionnaire.

  • Change in child sleep pattern from basline [ Time Frame: Enrollment, 12 months, 24 months ] [ Designated as safety issue: No ]
    Primary caregivers complete a 6-question sleep questionnaire on sleep timing (weekday and weekend bedtime and awakening)and sleep duration in hours as well as sleep latency for both themselves and the participating child.

  • Change in home environment from basline [ Time Frame: Enrollment, 12 months, 24 months ] [ Designated as safety issue: No ]
    Primary caregivers complete a 24 item questionnaire pertaining to the availability of supports and family routines relevant to physical activity and nutrition.

  • Change in adult Readiness to Change from basline [ Time Frame: Enrollment, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
    Primary caregivers complete a 7 item questionnaire pertaining to readiness to change behaviors relevant to obesity.

  • Change in adult SF-12 scores from basline [ Time Frame: Enrollment, 12 months, 24 months ] [ Designated as safety issue: No ]
    Primary caregivers complete a 12-item questionnaire that poses questions about their perception of their physical and emotional well being.

  • Stress questionnaire [ Time Frame: Enrollment, 12 months, 24 months ] [ Designated as safety issue: No ]
    Primary caregivers complete a 10-item questionnaire pertaining to perceptions of global areas of stress.

  • Change in adult sleep pattern from basline [ Time Frame: Enrollment, 12 months, 24 months ] [ Designated as safety issue: No ]
    Primary caregivers complete a 6-question sleep questionnaire on sleep timing (weekday and weekend bedtime and awakening)and sleep duration in hours as well as sleep latency for both themselves and the participating child.


Other Outcome Measures:
  • Parent 24 hour dietary recalls [ Time Frame: Enrollment, 12 month, 24 month ] [ Designated as safety issue: No ]
    24 hour dietary recalls (Nutrition Data Services) will be conducted on primary caregiver and child to provide validation of results obtained in the fruit and vegetable questionnaires. Child recalls will be conducted via caregiver proxies.

  • Cultural Identity Scale [ Time Frame: Enrollment, 12 months, 24 months ] [ Designated as safety issue: No ]
    Adult caregivers complete a 6-item measure of acculturation specific to American Indians that yields a general score for involvement in traditional culture. This measure is not expected to change as a result of the study but is being collected as a potential moderating variable.

  • Child Safety Survey [ Time Frame: 12 months, 18 months ] [ Designated as safety issue: No ]
    An 8-item questionnaire is completed by primary caregivers receiving the Child Safety active control intervention to assess their attention the the newsletters and obtain their feedback.

  • HCSF Participant Survey [ Time Frame: 12 months, 18 months ] [ Designated as safety issue: No ]
    A 26-item survey assess participant involvement and gathers feedback on the HCSF intervention and materials.

  • All Participant Exit Survey [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    A 30-item survey requests feedback on many aspects of the project.

  • Child 24 hour dietary recalls [ Time Frame: Enrollment, 12 month, 24 month ] [ Designated as safety issue: No ]
    24 hour dietary recalls (Nutrition Data Services) will be conducted on primary caregiver and child to provide validation of results obtained in the fruit and vegetable questionnaires. Child recalls will be conducted via caregiver proxies.


Estimated Enrollment: 900
Study Start Date: January 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy Children, Strong Families (first)
Healthy Children, Strong Families intervention (first). This is a series of monthly educational tool kits mailed to primary caregivers for use with the participating child. This arm crosses over to receive the Child Safety in Year 2.
Behavioral: Healthy Children, Strong Families
Healthy Children, Strong Families is a series of 13 "lessons" mailed to primary caregivers of preschool aged children that provide education and activities related to obesity prevention. The lessons cover topics related to nutrition, physical activity, stress, sleep, and the home environment. Lessons include printed materials and small items (for example, an apple sectioner) that support activities in the lessons. Social support components via a monitored Facebook group and approximately semiweekly text messages sent to caregivers are included. The intervention spans 1 year.
Behavioral: Child Safety
The Child Safety intervention is an active control condition consisting of monthly two-page newsletters covering various topics relevant to child safety such as choking, car safety seats, bike and pedestrian safety. The intervention spans 1 year.
Active Comparator: Child Safety (first)
A series of 12 monthly newsletters and providing education on child safety mailed to primary caregivers. This Arm crosses over to receive the Healthy Children, Strong Families intervention in Year 2.
Behavioral: Healthy Children, Strong Families
Healthy Children, Strong Families is a series of 13 "lessons" mailed to primary caregivers of preschool aged children that provide education and activities related to obesity prevention. The lessons cover topics related to nutrition, physical activity, stress, sleep, and the home environment. Lessons include printed materials and small items (for example, an apple sectioner) that support activities in the lessons. Social support components via a monitored Facebook group and approximately semiweekly text messages sent to caregivers are included. The intervention spans 1 year.
Behavioral: Child Safety
The Child Safety intervention is an active control condition consisting of monthly two-page newsletters covering various topics relevant to child safety such as choking, car safety seats, bike and pedestrian safety. The intervention spans 1 year.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776255

Contacts
Contact: Katherine A Cronin, MPH 608-263-5869 kate.cronin@fammed.wisc.edu
Contact: Ronald J Prince, MS 608-263-2228 ron.prince@fammed.wisc.edu

Locations
United States, Minnesota
White Earth Child Care Program Active, not recruiting
White Earth, Minnesota, United States, 56591
United States, New Mexico
First Nations HealthSource Active, not recruiting
Albuquerque, New Mexico, United States, 87108
United States, New York
Seneca Nation Recruiting
Irviing, New York, United States, 14081
United States, Wisconsin
Menominee Tribe of Wisconsin Active, not recruiting
Keshena, Wisconsin, United States, 54135
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Alexandra K Adams, MD, PhD University of Wisconsin, Madison
  More Information

Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01776255     History of Changes
Other Study ID Numbers: 2012-0578, 1R01HL114912-01
Study First Received: January 16, 2013
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Obesity
Overweight
Lifestyle
American Indian

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 19, 2014