Communities for healthy living (CHL) – A family-centered childhood obesity prevention program integrated into Head Start services: Study protocol for a pragmatic cluster randomized trial

Abstract

Authors' contributions: KKD is the principal investigator and is responsible for overall direction and conduct of the study; KKD conceived the study along with co-investigators JMJ, EMT and SH. JM leads the study's participatory process and developed the empowerment measures. SH, the study biostatistician, developed the analytic strategy and will oversee primary data analyses. EMT oversees the assessment of environmental factors affecting intervention outcomes. JB led preparation of this paper, co-developed the Parents Connect for Healthy Living (PConnect) curriculum, and participates in survey preparation, participant recruitment, and data collection. AAT manages the implementation of the study, participates in survey preparation, participant recruitment and data collection, and co-developed the Parents Connect for Healthy Living (PConnect) curriculum. NK oversaw the quality and integrity of the data. KL, CK, and AV oversee day-to-day implementation of the intervention within Head Start and assist with recruitment, data collection, and data processing. AG developed the online Community Resource Guide and participates in survey preparation, participant recruitment, and data collection. RF and BK assisted with the intervention design and participate in survey preparation, participant recruitment, and data collection. RK and RB participated in intervention design and RB designed all intervention artwork. All of the authors have reviewed, edited, and approved the manuscript.

Communities for Healthy Living (CHL) A Community-based Intervention to Prevent Obesity in Low-Income Preschool Children: Process Evaluation Protocol

“…This decision has both theoretical and pragmatic motivations. Both enhanced nutrition support and the media campaign are conceptualized as Head Start program-level interventions meant to achieve organizational empowerment by enhancing the capacity of the programs to promote health among the families they serve [ 11 ]. Therefore, the process evaluation for these components includes how staff are trained and the resources given to programs.…”

“…CHL will be implemented in 16 Head Start programs, which encompass 23 individual centers, throughout Boston, Cambridge, and Somerville, MA, from fall 2017 to spring 2020. A comprehensive description of the intervention and trial design is presented in the main protocol paper [11]. As summarized briefly below, the intervention has three main components including (a) the Parents Connect for Healthy Living (PConnect) program, (b) enhanced nutrition support, and (c) a media campaign.…”

“…No adaptations are expected for the content of printed materials used in enhanced nutrition support and the media campaign, as the Community Advisory Board comprised of Head Start staff, teachers, and parents thoroughly reviewed these materials before the intervention began [11]. Modifications to the frequency and/or duration of enhanced nutrition support trainings are documented in administrative records.…”

“…CHL is a complex intervention, originally developed in collaboration with low-income parents using CBPR, to prevent obesity in preschool-aged children enrolled in Head Start. Following process evaluation guidelines outlined by Grant et al [10] and expanding on a brief description of CHL's process evaluation in the main trial protocol [11], this protocol paper provides comprehensive information on CHL's implementation, adaptation, and context. Results from the process evaluation will aid the interpretation of the main trial results and inform future scale-up efforts.…”

Acceptability and Appropriateness of a Novel Parent-Staff Co-Leadership Model for Childhood Obesity Prevention in Head Start: A Qualitative Interview Study

“…Communities for Healthy Living (CHL), an ongoing childhood obesity prevention trial in Head Start [26] (clinicaltrials.gov NCT03334669), is among the rst to engage Head Start parents as peer leaders. Parents are recruited to facilitate a 10-session parent program called Parents Connect for Healthy Living (PConnect).…”