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dc.contributor.authorTomayko, Emily J.
dc.contributor.authorPrince, Ronald J.
dc.contributor.authorCronin, Kate A.
dc.contributor.authorParker, Tassy
dc.contributor.authorKim, KyungMann
dc.contributor.authorGrant, Vernon M.
dc.contributor.authorSheche, Judith N.
dc.contributor.authorAdams, Alexandra K.
dc.date.accessioned2019-04-25T14:41:27Z
dc.date.available2019-04-25T14:41:27Z
dc.date.issued2017-04
dc.identifier.citationTomayko, Emily J., Ronald J. Prince, Kate A. Cronin, Tassy Parker, KyungMann Kim, Vernon M. Grant, Judith N. Sheche, and Alexandra K. Adams. “Healthy Children, Strong Families 2: A Randomized Controlled Trial of a Healthy Lifestyle Intervention for American Indian Families Designed Using Community-Based Approaches.” Clinical Trials 14, no. 2 (January 9, 2017): 152–161. doi:10.1177/1740774516685699.en_US
dc.identifier.issn1740-7745
dc.identifier.urihttps://scholarworks.montana.edu/xmlui/handle/1/15472
dc.description.abstractBackground/Aims Few obesity prevention trials have focused on young children and their families in the home environment, particularly in underserved communities. Healthy Children, Strong Families 2 is a randomized controlled trial of a healthy lifestyle intervention for American Indian children and their families, a group at very high risk of obesity. The study design resulted from our long-standing engagement with American Indian communities, and few collaborations of this type resulting in the development and implementation of a randomized clinical trial have been described. Methods Healthy Children, Strong Families 2 is a lifestyle intervention targeting increased fruit and vegetable intake, decreased sugar intake, increased physical activity, decreased TV/screen time, and two less-studied risk factors: stress and sleep. Families with young children from five American Indian communities nationwide were randomly assigned to a healthy lifestyle intervention (Wellness Journey) augmented with social support (Facebook and text messaging) or a child safety control group (Safety Journey) for 1 year. After Year 1, families in the Safety Journey receive the Wellness Journey, and families in the Wellness Journey start the Safety Journey with continued wellness-focused social support based on communities’ request that all families receive the intervention. Primary (adult body mass index and child body mass index z-score) and secondary (health behaviors) outcomes are assessed after Year 1 with additional analyses planned after Year 2. Results To date, 450 adult/child dyads have been enrolled (100% target enrollment). Statistical analyses await trial completion in 2017. Lessons learned Conducting a community-partnered randomized controlled trial requires significant formative work, relationship building, and ongoing flexibility. At the communities’ request, the study involved minimal exclusion criteria, focused on wellness rather than obesity, and included an active control group and a design allowing all families to receive the intervention. This collective effort took additional time but was critical to secure community engagement. Hiring and retaining qualified local site coordinators was a challenge but was strongly related to successful recruitment and retention of study families. Local infrastructure has also been critical to project success. Other challenges included geographic dispersion of study communities and providing appropriate incentives to retain families in a 2-year study. Conclusion This multisite intervention addresses key gaps regarding family/home-based approaches for obesity prevention in American Indian communities. Healthy Children, Strong Families 2’s innovative aspects include substantial community input, inclusion of both traditional (diet/activity) and less-studied obesity risk factors (stress/sleep), measurement of both adult and child outcomes, social networking support for geographically dispersed households, and a community selected active control group. Our data will address a literature gap regarding multiple risk factors and their relationship to health outcomes in American Indian families.en_US
dc.description.sponsorshipNational Institutes of Health, National Heart, Lung, and Blood Institute (grant number 1R01HL114912); NIH T32 training grants to the University of Wisconsin Department of Nutritional Sciences (5T32DK007665); Department of Family Medicine and Community Health (T32HP10010)en_US
dc.language.isoenen_US
dc.rightsThis Item is protected by copyright and/or related rights. You are free to use this Item in any way that is permitted by the copyright and related rights legislation that applies to your use. For other uses you need to obtain permission from the rights-holder(s).en_US
dc.rights.urihttp://rightsstatements.org/vocab/InC/1.0/en_US
dc.titleThe Healthy Children, Strong Families 2: a randomized controlled trial of a healthy lifestyle intervention for American Indian families designed using community-based approachesen_US
dc.typeArticleen_US
mus.citation.extentfirstpage151en_US
mus.citation.extentlastpage162en_US
mus.citation.issue2en_US
mus.citation.journaltitleClinical Trialsen_US
mus.citation.volume14en_US
mus.identifier.categorySocial Sciencesen_US
mus.identifier.doi10.1177/1740774516685699en_US
mus.relation.collegeOther Departments & Programsen_US
mus.relation.universityMontana State University - Bozemanen_US
mus.data.thumbpage15en_US


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