Healthy Children, Strong Families 2: A randomized controlled trial of a healthy lifestyle intervention for American Indian families designed using community-based approaches.

Background/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.

Effects of an Obesity Prevention Intervention on Physical Activity Among Preschool Children: The CHILE Study.

Background Limited research addresses interventions to increase physical activity among American Indian and Hispanic preschool-aged children living in rural areas. We examined the impact of a Head Start-based intervention (Child Health Initiative for Lifelong Eating and Exercise [CHILE]) on physical activity at home. Method Sixteen Head Start centers in predominantly Hispanic or American Indian communities were group randomized to the six-component intervention or a comparison group for 2 years. Structured surveys were administered at four assessment times to a convenience sample of caregivers of 655 children in the study. Multilevel modeling was used to assess the effects of the intervention on physical activity. Results The relative change in physical activity in the intervention group compared with the comparison group over the 2-year period was 1.56 (95% confidence interval [1.02, 2.38]; p = .04). Among specific promoted activities (ball playing, dancing, active games, jumping, and walking), dancing increased significantly in the intervention compared with the comparison group (2.9; 95% confidence interval [1.2, 7.1]; p = .02). Conclusions The CHILE intervention was effective at increasing physical activity at home in preschool children in priority populations. Future research should focus on increasing family involvement and strengthening messaging about physical activity in these populations.

Cultural adaptation, psychometric properties, and outcomes of the Native American Spirituality Scale.

Spirituality is central to many Native Americans (NAs) and has been associated with recovery from substance use disorders (SUDs). However, no published questionnaire uniquely taps tribal-specific spiritual beliefs and practices. This hinders efforts to integrate traditional NA spirituality into SUD treatment and track spiritual outcomes. As part of a randomized controlled trial examining SUD treatment for NAs, we adapted the Daily Spiritual Experience Scale (DSES) in collaboration with members of a Southwest tribe to create the Native American Spirituality Scale (NASS) and measured changes in the NASS over the course of treatment. The 83 participants (70% male) were from a single Southwest tribe and seeking SUD treatment. They completed the NASS at baseline, 4, 8, and 12 months. Exploratory factor analysis of the NASS was conducted and its temporal invariance, construct validity, and longitudinal changes in the factor and item scores were examined. The NASS yielded a 2-factor structure that was largely invariant across time. Factor 1 reflected behavioral practices, while Factor 2 reflected more global beliefs. Both factors significantly increased across 12 months, albeit at different assessment points. At baseline, Factor 1 was negatively related to substance use and positively associated with measures of tribal identification while Factor 2 was unrelated to these measures. Given the importance of tribal spirituality to many NAs, the development of this psychometrically sound measure is a key precursor and complement to the incorporation of tribal spirituality into treatment, as well as research on mechanisms of change for SUD treatment among NAs and assessment of NA spirituality in relation to other aspects of health.