Clinical trial NCT01776255: Healthy Children, Strong Families: American Indian Communities Preventing Obesity
Official title: Healthy Children, Strong Families: American Indian Communities Preventing Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Obesity
Overweight
Lifestyle
American Indian
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-01-28
Enrollment: 900
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: Change in child adiposity from baseline measured via BMI z-score
timeFrame: Enrollment, 6 months, 12 months, 18 months, 24 months
measure: Change in adult adiposity from baseline measured via BMI
timeFrame: Enrollment, 12 months, 24 months
Secondary outcomes:
measure: Change in child adiposity from baseline measured via waist circumference
timeFrame: Enrollment, 6 months, 12 months, 18 months, 24 months
measure: Change in adult adiposity from baseline measured via waist circumference
timeFrame: Enrollment, 12 months, 24 months
measure: Change in child fruit and vegetable consumption from baseline
timeFrame: Enrollment, 12 months, 24 months
measure: Change in adult fruit and vegetable consumption from basline
timeFrame: Enrollment, 12 months, 24 months
measure: Change in amount of child screen time from basline
timeFrame: Enrollment, 12 month, 24 month
measure: Change in amount of adult screen time from basline
timeFrame: Enrollment, 12 month, 24 month
measure: Change in amount of child physical activity from baseline
timeFrame: Enrollment, 12 months, 24 months
measure: Change in amount of adult physical activity from basline
timeFrame: Enrollment, 12 months, 24 months
measure: Change in child sleep pattern from basline
timeFrame: Enrollment, 12 months, 24 months
measure: Change in home environment from basline
timeFrame: Enrollment, 12 months, 24 months
measure: Change in adult Readiness to Change from basline
timeFrame: Enrollment, 6 months, 12 months, 18 months, 24 months
measure: Change in adult SF-12 scores from basline
timeFrame: Enrollment, 12 months, 24 months
measure: Stress questionnaire
timeFrame: Enrollment, 12 months, 24 months
measure: Change in adult sleep pattern from basline
timeFrame: Enrollment, 12 months, 24 months
Other outcomes:
measure: Parent 24 hour dietary recalls
timeFrame: Enrollment, 12 month, 24 month
measure: Cultural Identity Scale
timeFrame: Enrollment, 12 months, 24 months
measure: Child Safety Survey
timeFrame: 12 months, 18 months
measure: HCSF Participant Survey
timeFrame: 12 months, 18 months
measure: All Participant Exit Survey
timeFrame: 24 months
measure: Child 24 hour dietary recalls
timeFrame: Enrollment, 12 month, 24 month
Locations:
city: White Earth
country: United States
facility: White Earth Child Care Program
state: Minnesota
city: Browning
country: United States
facility: Blackfeet Nation
state: Montana
city: Albuquerque
country: United States
facility: First Nations HealthSource
state: New Mexico
city: Irving
country: United States
facility: Seneca Nation
state: New York
city: Keshena
country: United States
facility: Menominee Tribe of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Alexandra K Adams, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.