Study design
The pilot study utilized a non-experimental, pre/post within-subjects design in a community-based setting. The study involved a community partnership with Clinica Esperanza/Hope Clinic (CEHC), a clinic providing free healthcare services and programs to uninsured adults. The intervention was delivered by formally trained community paraprofessionals called Navegantes. A total of five Navegantes delivered the HCHF intervention to participants over the 2-year study period, with 2-3 navegantes teaching or facilitating each lesson at a time. All Navagantes were women from the surrounding community that were employed at CEHC. Over the course of 2 years (2014-2016), parents of 3-11-year-old children were recruited to participate in the study, which was framed as a community program entitled ‘Niños Activos y Sanos: Healthy & Active Children’. All of the protocols in the study were approved by the University of Rhode Island Institutional Review Board.
Participants and recruitment
Both parents and primary caregivers, such as grandparents, (all referred to as ‘parents’ throughout this manuscript) with a child between the ages of 3-11 years were recruited. The target population were parents living in Olneyville and South Providence, Rhode Island where the median household income is $17,538, and 61% of the population is Hispanic [31].
Both in-person recruitment at different community settings (i.e. local parks, churches, community centers, events, etc.) and recruitment fliers were distributed throughout the community to recruit participants on a rolling basis from 2014 to 2016. In addition, researchers and Navegantes collaborated with community partners including other healthcare clinics and health-related programs to recruit parents for the study. Parents and/or primary caregivers were screened in-person or via telephone to determine eligibility. Participants were eligible to participate if they were a parent or primary caregiver of a child between 3 and 11 years of age at the beginning of enrollment and spoke English or Spanish. During the first year, 44 parents enrolled, 50 in year two (N = 94), with a total of nine groups of parents completing the intervention over the 2 year period. Groups occurred sequentially over the two-year study period. During the second year, the intervention was reduced by 1 week in effort to improve study retention.
Intervention
Navegantes participated in a formal 2-day training prior to delivering the HCHF curriculum, which was delivered primarily in Spanish. Based on previous evidence, the HCHF curriculum was designed to provide parents with strategies to help children adopt behaviors that promote a healthy weight [26, 27]. Through problem-solving strategies and role-playing, the HCHF intervention highlights ‘paths to success’ (nutrition and physical behaviors) and ‘keys to success’ (parental strategies to facilitate progress on the path to healthy behaviors in families, which highlight several responsive FPPs, and encourage parents to use these practices at home) [26, 27].
For example, paths to success include ‘eating more fruits and vegetables’, ‘eating fewer high-fat and high-sugar foods’, ‘playing actively’, and ‘limiting television and computer time’ [26, 27]. Examples of keys to success include setting a good example for their child (modeling), and offering healthy choices within limits (guiding, or encouraging a balanced and varied diet) [26, 27].
Parents attended 90-min, weekly sessions of HCHF, which were conducted on Wednesday evenings, usually beginning at 5:30 pm. Written informed consent was obtained from all participants. Parents completed written informed consent forms to participate in the study and informed assent/written permission forms for their child if they were under the age of 7 years. Modified forms were used to allow children over the age of seven to better understand the study and provide written informed assent to participate. After consent was obtained from all participants, parents and children completed anthropometric measurements and parents then completed a written survey. Researchers were present during completion of consent forms and surveys to answer questions, assist parents who could not read or write, and provide clarification as needed. All study materials were available in both English and Spanish. The intervention was designed for the parents, given their role in shaping their child’s environment and behaviors. During the sessions however, childcare and nutrition lessons were provided to children if parents chose to bring them. Parents then returned to CEHC weekly, for a total of eight sessions to complete the intervention. At the last session, the same procedures were repeated to collect post-intervention data (with the exception of consent forms). Parents were compensated with a $10 gift card after the first session, and a $40 gift card following the last session. Each session also included a weekly prize (such as pedometers, mixing bowls, and spatulas) for parents and their children in addition to raffle prizes (such as food prep equipment, small kitchen tools).
Measures
Anthropometrics
Standing height and weight measurements of each parent-child dyad were taken using standardized procedures [32], taken in duplicate. Parent’s BMI was calculated based on their height and weight. Pre and post-intervention BMI percentiles were calculated for children using age- and sex-specific references [32, 33].
Survey
The self-administered survey consisted of 84 questions and parents answered questions as it pertained to their child that was consented to participate in the study. Parents with more than one child between ages 3-11 were instructed to base their responses on their youngest child within that age range. The decision to do this was driven by the literature on the importance of shaping health behaviors early in life given that these track into later childhood [4, 6, 7, 9, 10, 16, 21].
Parents were asked to report on the following socio-demographic characteristics: age, sex, ethnicity, race, education level, number/ages of children, marital status, if they were born in the U.S., number of years in the U.S., employment status, health insurance status, annual household income, child date of birth, and child gender.
Reported food parenting practices were assessed using seven subscales from the previously validated CFPQ [34], including modeling (4 items; α = 0.79), involvement (3 items; α = 0.89), encouraging balance and variety (4 items; α = 0.72), and teaching about nutrition (3 items; α = 0.42). Response options, ranged on a scale from disagree (1), disagree slightly (2), neutral (3), slightly agree (4), to agree (5) [34]. Subscale means were calculated for the seven subscales, with a higher score on each subscale indicating greater agreement with the corresponding practice.
To assess frequency of parent and child health behaviors, including dietary and physical activity/screen time behaviors (11 items), and home environment/parenting behaviors (5 items), parents completed the self-reported 16-item HCHF-BC [30]. Each item was assessed using a 5-point response scale from least to most frequent options in a range of frequencies appropriate to each reported behavior [30]. For example, for some of the questions response options ranged from (1) once in a while, (2) 1-2 days each week, (3) 3-4 days each week, (4) 5-6 days each week, to (5) every day or from (1) almost never, (2) 1-3 days each week, (3) 4-6 days each week, (4) once each day, to (5) 2 or more times each day. Mean scores for each item were calculated for analysis.
In addition to study objectives focused on parental feeding and diet and activity measures, a brief evaluation survey (14 questions) was provided to parents at the end of the final HCHF session, in effort to obtain their opinions and feedback on the program. Twenty participants that completed the study filled out an evaluation survey (surveys were provided in both English and Spanish).
Statistical analysis
Post-hoc analysis was completed to assess if there were significant changes between demographic variables for study completers vs. non-completers. Chi-square tests for categorical variables and an ANOVA for continuous variables were completed to compare demographics between completers and non-completers. Paired samples t-tests were performed to assess for statistically significant changes pre/post intervention for seven CFPQ subscales and the 16-item HCHF-BC. Given that this was a pilot study to assess the preliminary efficacy of the intervention, it was not adequately powered for multivariate analyses. To account for multiple comparisons, a conservative significance level was set post hoc for the t-tests at p ≤ 0.01. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
To assess parent participation, attendance was recorded at each session. Parents were considered study completers and were included in data analyses if they attended four or more of the eight sessions in year one, or three or more of the seven sessions in year two. To assess intervention fidelity (described as the extent to which the intervention is delivered as it was intended) [35], 59% of the HCHF sessions were observed by a trained research assistant using a previously-developed observation checklist. All statistical analysis was performed using SPSS version 23.