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

Abstract

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 (HCSF2) 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 an RCT have been described. Methods HCSF2 is a lifestyle intervention targeting increased fruit and vegetable intake, decreased sugar intake, increased physical activity, decreased TV/screen time, and two lesser-studied risk factors: stress and sleep. Families with young children from five American Indian communities nationwide were randomly assigned to a healthy lifestyles intervention (Wellness Journey) augmented with social support (Facebook and text messaging) or a child safety control group (Safety Journey) for one 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 two-year study. Conclusions This multi-site intervention addresses key gaps regarding family/home-based approaches for obesity prevention in American Indian communities. HCSF2’s innovative aspects include substantial community input, inclusion of both traditional (diet/activity) and lesser-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 relation...

Overnight sleep duration and obesity in 2–5 year‐old American Indian children

“…This cross‐sectional study was based on the HCSF2 baseline data. HCSF2 was a randomized controlled trial of an obesity prevention intervention that has been described in detail elsewhere …”

How patient and community involvement in diabetes research influences health outcomes: A realist review

“…In some places, the Advisory Board was established first in order to set priorities for the research , while in other settings, the project was initiated by academics ‐ . In the five projects that were conducted in First Nation settings (British Columbia; FEDS; HCSF; Kahnawake; Sandy Lake) the Tribal Councils had legal authority over decisions to conduct research on the reservations, which placed academics in a position of making a formal application to work with communities.…”

“…For example, the availability and cost of food was mapped and used to leverage local resources to provide healthier and more affordable choices , . In some projects, one approach to intervention development was tried and evaluated before revising ‐ or moving on to another strategy while others adopted a multifaceted approach which included a number of local activities which ran in tandem , , . Responsiveness to local conditions was noted to be key in designing interventions.…”

“…Trials used inclusive approaches to establishing control groups. There was randomization at household level, with additional family members assigned to the same intervention , , and active control groups where all families received a version of the intervention ‐ . Stepped recruitment successfully retained control group participation because people believed that they would eventually receive the intervention.…”

“…High rates of recruitment and retention were attributed to locally led recruitment teams who were sensitive to neighbourhood constraints and possibilities, and who were involved at proposal, recruitment and data collection stages ‐ , , , , . The expertise and connections of respected community agencies promoted trust and acceptability, ‘which likely decreased participant withdrawal from the study’:363.…”