Overview

This trial is active, not recruiting.

Conditions obesity, overweight
Treatments healthy children, strong families, child safety
Sponsor University of Wisconsin, Madison
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date January 2013
End date April 2017
Trial size 900 participants
Trial identifier NCT01776255, 1R01HL114912-01, 2012-0578

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(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.
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.
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)
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.
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.
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.

Primary Outcomes

Measure
Change in child adiposity from baseline measured via BMI z-score
time frame: Enrollment, 6 months, 12 months, 18 months, 24 months
Change in adult adiposity from baseline measured via BMI
time frame: Enrollment, 12 months, 24 months

Secondary Outcomes

Measure
Change in child adiposity from baseline measured via waist circumference
time frame: Enrollment, 6 months, 12 months, 18 months, 24 months
Change in adult adiposity from baseline measured via waist circumference
time frame: Enrollment, 12 months, 24 months
Change in child fruit and vegetable consumption from baseline
time frame: Enrollment, 12 months, 24 months
Change in adult fruit and vegetable consumption from basline
time frame: Enrollment, 12 months, 24 months
Change in amount of child screen time from basline
time frame: Enrollment, 12 month, 24 month
Change in amount of adult screen time from basline
time frame: Enrollment, 12 month, 24 month
Change in amount of child physical activity from baseline
time frame: Enrollment, 12 months, 24 months
Change in amount of adult physical activity from basline
time frame: Enrollment, 12 months, 24 months
Change in child sleep pattern from basline
time frame: Enrollment, 12 months, 24 months
Change in home environment from basline
time frame: Enrollment, 12 months, 24 months
Change in adult Readiness to Change from basline
time frame: Enrollment, 6 months, 12 months, 18 months, 24 months
Change in adult SF-12 scores from basline
time frame: Enrollment, 12 months, 24 months
Stress questionnaire
time frame: Enrollment, 12 months, 24 months
Change in adult sleep pattern from basline
time frame: Enrollment, 12 months, 24 months

Eligibility Criteria

Male or female participants from 2 years up to 5 years old.

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)

Additional Information

Official title Healthy Children, Strong Families: American Indian Communities Preventing Obesity
Principal investigator Alexandra K Adams, MD, PhD
Description Intervention The Healthy Children, Strong Families-2 (HCSF-2) intervention consists of monthly mailed healthy lifestyle lessons (13 lessons) which will be dose enhanced with social networking support (cell-phone coaching with instant text messages and Facebook connections), as well as new intervention elements-stress and sleep. Social networking was chosen due to its widespread and ease of use, adaptability and potential for sustainability in the community. HCSF-2 is based on our hypothesis that working with children and their primary caregivers/parent to assist them in making healthy lifestyle changes is necessary to prevent excessive weight gain and risk of later lifestyle related chronic disease. Investigators will work with families at a critical time in their young child's physical and emotional development to encourage appropriate healthy lifestyle behaviors. This study will expand on our previous research to test the HCSF-2 intervention in a larger, more geographically and socially diverse sample of AI communities. The study also enhances the prior methodology through the inclusion of a social networking component. This research will address four key gaps in obesity prevention studies: families with preschool age children, social networking support, stress and sleep. Moreover, to our knowledge, this study will be the first family-based obesity intervention project for both rural and urban AI families. The potential impact of this study is high; if successful, this study will not only provide quantitative evidence of the effectiveness of the intervention but it will also give other investigators validated tools and procedures to collaboratively engage AI communities in health behavior change. Year 1, families will be randomized to start in the HCSF-2 intervention or an active control (mailed child safety newsletters). Then, in Year 2, intervention change will occur, such that HCSF-2 intervention families will receive the control safety lessons plus continued HCSF-2 social networking, while control families will now receive the full HCSF-2 intervention. For example, families will be randomly assigned to begin in one of the two arms - denoted here as the HCSF-2 intervention (Phase A) or Child Safety intervention (Phase B). During the HCSF-2 intervention (Phase A) families will receive a monthly mailing with information about nutrition and physical activity, screen time, sleep and stress management. Families will also be invited to participate in a private Facebook group and will begin receiving wellness coaching text messages from the study. During the Child Safety intervention (Phase B) families will receive a monthly mailing with information about safety topics such as car safety, water safety, poisoning and home safety. After one year, families will flip into the second phase until the two year study period is complete. Families who began in Phase A will continue to receive wellness coaching text messages and have access to the private Facebook group. Families who began in Phase B will not receive wellness coaching text messages or have access to the private Facebook group until the flip into Phase A at the start of year two. This staggered enrollment design, chosen in conjunction with the participating communities, maximizes the contribution of each participating family, avoids the negative attitudes that would occur with a wait-list only control and ensures all families receive the intervention as desired by the participating tribal sites. This is a multi-site trial with up to six possible participating communities. Two sites will become active at the beginning of the intervention with remaining sites becoming active (and being added to the IRB protocol) at roughly 1 year intervals. A local site coordinator will be hired at each participating site. The local site coordinator will be responsible for recruiting participants, and conducting data collection visits. Site coordinators may also send wellness coaching text messages and post content to the private Facebook group. The UW program coordinator will be responsible for screening participants for eligibility, administering 24-hour dietary recalls by phone, mailing HCSF-2 curriculum materials and Child Safety materials, managing the entry and storage of study data, sending results letters to participants and supporting the community site coordinators. Methods Investigators will partner with 6 diverse rural and urban AI communities nationally to conduct a 2-arm staggered-enrollment randomized trial of an enhanced version of the HCSF intervention (HCSF-2) vs. active control (Child Safety intervention) in a 2-year design with outcomes measured at 0, 6, 12, 18 and 24 months. At the end of year 1, control families will receive HCSF-2, and HCSF-2 families will receive the control intervention with continued HCSF-2 social network support. Communities will work with us to enhance the family-focused HCSF-2 intervention to include novel methods of delivery (mailed lessons with social networking/cell phone text coaching) and two less-studied obesity determinants—sleep and stress—to increase impact and sustainability. Outcomes Primary outcomes will be body fat as assessed by child Body Mass Index z-score (zBMI) and adult Body Mass Index (BMI). Secondary outcomes include adult and child waist circumference, fruit/vegetable (FV) and added sugar intake, TV/screen time, activity, sleep, home environment changes, adult psychosocial factors (stress/depression) and social network use. Investigators will also identify key mediators of the effect of HCSF-2 on obesity and health behaviors. We hypothesize that modifiable behavior changes in children and caregivers, adult self-efficacy, social support and home environment changes are important mediators of the effect of the intervention on obesity and other outcomes. Investigators will develop and test exploratory mixed-effects regression models to investigate mediation on the path from HCSF-2 to weight reduction.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.