Healthy Children, Strong Families: American Indian Communities Preventing Obesity

NCT01776255 | Completed DMC

• 2 other identifiers: 2012-05781R01HL114912-01
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Obesity; Overweight

Keywords

Obesity; Overweight; Lifestyle; American Indian

Outcome Measures

Primary Outcomes (2)

• Change in child adiposity from baseline measured via BMI z-score

  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

  Enrollment, 6 months, 12 months, 18 months, 24 months

• Change in adult adiposity from baseline measured via BMI

  Adult BMI is computed from weight (in kg) divided by height (in m) squared

  Enrollment, 12 months, 24 months

Secondary Outcomes (14)

• Change in child adiposity from baseline measured via waist circumference

  Enrollment, 6 months, 12 months, 18 months, 24 months

• Change in adult adiposity from baseline measured via waist circumference

  Enrollment, 12 months, 24 months

• Change in child fruit and vegetable consumption from baseline

  Enrollment, 12 months, 24 months

• Change in adult fruit and vegetable consumption from basline

  Enrollment, 12 months, 24 months

• Change in amount of child screen time from basline

  Enrollment, 12 month, 24 month

Other Outcomes (6)

• Parent 24 hour dietary recalls

  Enrollment, 12 month, 24 month

• Cultural Identity Scale

  Enrollment, 12 months, 24 months

• Child Safety Survey

  12 months, 18 months

Study Arms (2)

Healthy Children, Strong Families (first)

EXPERIMENTAL

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; Behavioral: Child Safety

Child Safety (first)

ACTIVE COMPARATOR

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; Behavioral: Child Safety

Interventions

Healthy Children, Strong Families BEHAVIORAL

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.

Child Safety (first); Healthy Children, Strong Families (first)

Child Safety BEHAVIORAL

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.

Child Safety (first); Healthy Children, Strong Families (first)

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Adult caregiver with a 2-5 year old child
• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (5)

White Earth Child Care Program

White Earth, Minnesota, 56591, United States

Location

Blackfeet Nation

Browning, Montana, 59417, United States

Location

First Nations HealthSource

Albuquerque, New Mexico, 87108, United States

Location

Seneca Nation

Irving, New York, 14081, United States

Location

Menominee Tribe of Wisconsin

Keshena, Wisconsin, 54135, United States

Location

Related Publications (8)

• Adams AK, LaRowe TL, Cronin KA, Prince RJ, Wubben DP, Parker T, Jobe JB. The Healthy Children, Strong Families intervention: design and community participation. J Prim Prev. 2012 Aug;33(4):175-85. doi: 10.1007/s10935-012-0275-y.

  PMID: 22956296 BACKGROUND

• Jobe JB, Adams AK, Henderson JA, Karanja N, Lee ET, Walters KL. Community-responsive interventions to reduce cardiovascular risk in American Indians. J Prim Prev. 2012 Aug;33(4):153-9. doi: 10.1007/s10935-012-0277-9.

  PMID: 22983753 BACKGROUND

• LaRowe TL, Wubben DP, Cronin KA, Vannatter SM, Adams AK. Development of a culturally appropriate, home-based nutrition and physical activity curriculum for Wisconsin American Indian families. Prev Chronic Dis. 2007 Oct;4(4):A109. Epub 2007 Sep 15.

  PMID: 17875253 BACKGROUND

• Tomayko EJ, Webber EJ, Cronin KA, Prince RJ, Adams AK. Use of Text Messaging and Facebook Groups to Support the Healthy Children, Strong Families 2 Healthy Lifestyle Intervention for American Indian Families. Curr Dev Nutr. 2021 May 17;5(Suppl 4):32-39. doi: 10.1093/cdn/nzaa110. eCollection 2021 Jun.

  PMID: 34222765 DERIVED

• Rink E, Knight K, Ellis C, McCormick A, FireMoon P, Held S, Webber E, Adams A. Using Community-Based Participatory Research to Design, Conduct, and Evaluate Randomized Controlled Trials with American Indian Communities. Prev Chronic Dis. 2020 Nov 12;17:E143. doi: 10.5888/pcd17.200099.

  PMID: 33180688 DERIVED

• Tomayko EJ, Prince RJ, Cronin KA, Kim K, Parker T, Adams AK. The Healthy Children, Strong Families 2 (HCSF2) Randomized Controlled Trial Improved Healthy Behaviors in American Indian Families with Young Children. Curr Dev Nutr. 2018 Nov 16;3(Suppl 2):53-62. doi: 10.1093/cdn/nzy087. eCollection 2019 Aug.

  PMID: 31453428 DERIVED

• Grant VM, Tomayko EJ, Prince RJ, Cronin K, Adams A. Understanding Correlates of Physical Activity in American Indian Families: The Healthy Children Strong Families-2 Study. J Phys Act Health. 2018 Nov 1;15(11):866-873. doi: 10.1123/jpah.2017-0584. Epub 2018 Oct 19.

  PMID: 30336717 DERIVED

• Tomayko EJ, Mosso KL, Cronin KA, Carmichael L, Kim K, Parker T, Yaroch AL, Adams AK. Household food insecurity and dietary patterns in rural and urban American Indian families with young children. BMC Public Health. 2017 Jun 30;17(1):611. doi: 10.1186/s12889-017-4498-y.

  PMID: 28666476 DERIVED

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Child Restraint Systems

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Infant Equipment; Equipment and Supplies; Protective Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Alexandra K Adams, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2013
• First Posted: January 28, 2013
• Study Start: January 1, 2013
• Primary Completion: April 27, 2017
• Study Completion: April 27, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

US (5)