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

University of Wisconsin (UW)

Status: Completed

Conditions: Overweight; Obesity

Treatments: Behavioral: Healthy Children, Strong Families; Behavioral: Child Safety

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01776255

2012-0578

1R01HL114912-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 900 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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900 participants in 2 patient groups

Healthy Children, Strong Families (first)

Experimental group

Description:

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.

Treatment:

Behavioral: Child Safety

Behavioral: Healthy Children, Strong Families

Child Safety (first)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Child Safety

Behavioral: Healthy Children, Strong Families