Evaluation of a cluster-randomized controlled trial: Communities for Healthy Living, family-centered obesity prevention program for Head Start parents and children.

BACKGROUND: This study reports the outcomes of Communities for Healthy Living (CHL), a cluster randomized obesity prevention trial implemented in partnership with Head Start, a federally-funded preschool program for low-income families. METHODS: Using a stepped wedge design, Head Start programs (n = 16; Boston, MA, USA) were randomly assigned to one of three intervention start times. CHL involved a media campaign and enhanced nutrition support. Parents were invited to join Parents Connect for Healthy Living (PConnect), a 10-week wellness program. At the beginning and end of each school year (2017-2019), data were collected on the primary outcome of child Body Mass Index z-score (BMIz) and modified BMIz, and secondary outcomes of child weight-related behaviors (diet, physical activity, sleep, media use) and parents' weight-related parenting practices and empowerment. Data from 2 years, rather than three, were utilized to evaluate CHL due to the COVID-19 pandemic. We used mixed effects linear regression to compare relative differences during intervention vs. control periods (n = 1274 vs. 2476 children) in (1) mean change in child BMIz and modified BMIz, (2) the odds of meeting child health behavior recommendations, (3) mean change in parenting practices, and (4) mean change in parent empowerment. We also compared outcomes among parents who chose post-randomization to participate in PConnect vs. not (n = 55 vs. 443). RESULTS: During intervention periods (vs. control), children experienced greater increases in BMIz and modified BMIz (b = 0.06, 95% CI = 0.02,0.10; b = 0.07, 95% CI = 0.03, 0.12), yet were more likely to meet recommendations related to three of eight measured behaviors: sugar-sweetened beverage consumption (i.e., rarely consume; Odds Ratio (OR) = 1.5, 95% CI = 1.2,2.3), water consumption (i.e., multiple times per day; OR = 1.6, 95% CI = 1.2,2.3), and screen time (i.e., ≤1 hour/day; OR = 1.4, 95% CI = 1.0,1.8). No statistically significant differences for intervention (vs. control) periods were observed in parent empowerment or parenting practices. However, parents who enrolled in PConnect (vs. not) demonstrated greater increases in empowerment (b = 0.17, 95% CI = 0.04,0.31). CONCLUSIONS: Interventions that emphasize parent engagement may increase parental empowerment. Intervention exposure was associated with statistically, but not clinically, significant increases in BMIz and increased odds of meeting recommendations for three child behaviors; premature trial suspension may explain mixed results. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03334669 , Registered October 2017.

Adaptation and implementation outcomes of a parenting program for low-income, ethnically diverse families delivered virtually versus in-person.

Driven by the COVID-19 pandemic, many in-person health behavior interventions were compelled to quickly pivot to a virtual format with little time or capacity to reflect on or examine possible equity-related implications of a format that required digital access and remote learning skills. Using a parenting program for low-income families as a case study, this paper (a) outlines the process of adapting the program from an in-person to a virtual format and (b) examines the equity-related implications of this adaptation. Parents Connect for Healthy Living (PConnect) is a 10-session empowerment-focused parenting intervention designed to promote family health for Head Start families. In 2020, PConnect was adapted over a 6-month period from an in-person to a virtual format due to the advent of the COVID-19 pandemic. Three core elements were retained in the adaptation; session content, provision of coaching support for facilitators, and the co-facilitation model. Key modifications include session length, group composition, and language of program delivery. Head Start and PConnect records provided data to compare reach, acceptability, and appropriateness of virtual and in-person PConnect. Seventy-eight parents enrolled in the in-person program and 58 in the virtual program. Participant demographics and satisfaction were similar across formats, and demographics similar to the general Head Start population. Participation was higher in the virtual format. Parents participated in the virtual program primarily via smart phones (68%). This case study supports the acceptability and appropriateness of virtual parenting programs in ethnically diverse, low-resource settings.

The purpose of this study was to examine the process of adapting an in-person health and empowerment parenting program, Parents Connect for Healthy Living (PConnect), to a virtual format, and examine if this adaptation and implementation of the virtual format led to inequities. Modifications to in-person PConnect to accommodate a virtual format included session length, group composition, and language of program delivery. Participant demographics and satisfaction were similar across the in-person and virtual formats. Attendance was slightly higher in the virtual format, and differences in attendance rates by race/ethnicity in the virtual program were less apparent. Findings from this case study indicate future programs for parents in low-resource settings should consider a virtual or hybrid approach.

Summer Weight Gain Among Preschool-Aged Children With Obesity: An Observational Study in Head Start.

School-aged children gain weight most rapidly in summer, but few studies have investigated summer weight gain among preschool-aged children. We fit continuous linear spline mixed models to test for accelerated summer weight gain among 2,044 children attending 16 Boston-area Head Start programs between fall 2016 and spring 2019. Academic year and summer rates of change in modified body mass index z-score differed (P < .001), with accelerated summer weight gain most pronounced among children with obesity. As with school-aged children, increased focus on the summer is warranted for promoting healthy weight among children in Head Start.

Acceptability and appropriateness of a novel parent-staff co-leadership model for childhood obesity prevention in Head Start: a qualitative interview study.

BACKGROUND: Peer leadership can be an effective strategy for implementing health programs, benefiting both program participants and peer leaders. To realize such benefits, the peer leader role must be appropriate for the community context. Also, peer leaders must find their role acceptable (i.e., satisfactory) to ensure their successful recruitment and retention. To date, parent peer leaders have seldom been part of early childhood obesity prevention efforts. Moreover, parents at Head Start preschools have rarely been engaged as peer leaders. The aim of this study is to evaluate the appropriateness and acceptability of an innovative model for engaging parents as peer leaders for this novel content area (early childhood obesity prevention) and setting (Head Start). METHODS: Parents Connect for Healthy Living (PConnect) is a 10-session parent program being implemented in Head Start preschools as part of the Communities for Healthy Living early childhood obesity prevention trial. PConnect is co-led by a parent peer facilitator who is paired with a Head Start staff facilitator. In the spring of 2019, 10 PConnect facilitators participated in a semi-structured interview about their experience. Interview transcripts were analyzed by two coders using an inductive-deductive hybrid analysis. Themes were identified and member-checked with two interviewees. RESULTS: Themes identified applied equally to parent and staff facilitators. Acceptability was high because PConnect facilitators were able to learn and teach, establish meaningful relationships, and positively impact the parents participating in their groups, although facilitators did express frustration when low attendance limited their reach. Appropriateness was also high, as PConnect provided adequate structure and support without being overly rigid, and facilitators were able to overcome most challenges they encountered. CONCLUSIONS: The PConnect co-facilitation model was highly acceptable and appropriate for both the parent facilitators (peer leaders) and the staff facilitators. Including parents as peer leaders aligns to Head Start's emphasis on parent engagement, making it a strong candidate for sustained implementation in Head Start. The insights gained about the drivers of peer leadership appropriateness and acceptability in this particular context may be used to inform the design and implementation of peer-led health programs elsewhere. TRIAL REGISTRATION: clinicaltrials.gov, NCT03334669 (7-11-17).

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

BACKGROUND: Process evaluation can illuminate barriers and facilitators to intervention implementation as well as the drivers of intervention outcomes. However, few obesity intervention studies have documented process evaluation methods and results. Community-based participatory research (CBPR) requires that process evaluation methods be developed to (a) prioritize community members' power to adapt the program to local needs over strict adherence to intervention protocols, (b) share process evaluation data with implementers to maximize benefit to participants, and (c) ensure partner organizations are not overburdened. Co-designed with low-income parents using CBPR, Communities for Healthy Living (CHL) is a family-centered intervention implemented within Head Start to prevent childhood obesity and promote family well-being. We are currently undertaking a randomized controlled trial to test the effectiveness of CHL in 23 Head Start centers in the greater Boston area. In this protocol paper, we outline an embedded process evaluation designed to monitor intervention adherence and adaptation, support ongoing quality improvement, and examine contextual factors that may moderate intervention implementation and/or effectiveness. METHODS: This mixed methods process evaluation was developed using the Pérez et al. framework for evaluating adaptive interventions and is reported following guidelines outlined by Grant et al. Trained research assistants will conduct structured observations of intervention sessions. Intervention facilitators and recipients, along with Head Start staff, will complete surveys and semi-structured interviews. De-identified data for all eligible children and families will be extracted from Head Start administrative records. Qualitative data will be analyzed thematically. Quantitative and qualitative data will be integrated using triangulation methods to assess intervention adherence, monitor adaptations, and identify moderators of intervention implementation and effectiveness. DISCUSSION: A diverse set of quantitative and qualitative data sources are employed to fully characterize CHL implementation. Simultaneously, CHL's process evaluation will provide a case study on strategies to address the challenges of process evaluation for CBPR interventions. Results from this process evaluation will help to explain variation in intervention implementation and outcomes across Head Start programs, support CHL sustainability and future scale-up, and provide guidance for future complex interventions developed using CBPR. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03334669 . Registered on October 10, 2017.

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.

BACKGROUND: Childhood obesity is highly prevalent and carries substantial health consequences. Childhood obesity interventions have had mixed results, which may be partially explained by the absence of theory that incorporates broader family context and methods that address implementation challenges in low-resource settings. Communities for Healthy Living (CHL) is an obesity prevention program for Head Start preschools designed with careful focus on theory and implementation. This protocol paper outlines the design, content, implementation, and evaluation of CHL. METHODS/DESIGN: CHL integrates a parenting program co-led by Head Start staff and parents, enhanced nutrition support, and a media campaign. CHL content and implementation are informed by the Family Ecological Model, Psychological Empowerment Theory, and Organizational Empowerment Theory. The intervention is directed by community-based participatory research and implementation science principles, such as co­leadership with parents and staff, and implementation in a real world context. CHL is evaluated in a three-year pragmatic cluster-randomized trial with a stepped wedge design. The primary outcome is change in child Body Mass Index z-score. Secondary outcomes include children's weight-related behaviors (i.e., diet, physical activity, screen use, and sleep), parenting practices targeted at these behaviors (e.g., food parenting), and parent empowerment. The evaluation capitalizes on routine health data collected by Head Start (e.g., child height and weight, diet) coupled with parent surveys completed by subsamples of families. DISCUSSION: CHL is an innovative childhood obesity prevention program grounded in theory and implementation science principles. If successful, CHL is positioned for sustained implementation and nationwide Head Start scale-up.