Clinical trial NCT01814215: Keys to Healthy Family Child Care Homes
Official title: The Business of Childcare Homes & Child Health: Innovations for Nurturing Growth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Prevention and Control
Diet
Motor Activity
Intervention Studies
Child, Preschool
Child Care
Food Habits
Feeding Behavior
Child Behavior
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Duke University
First posted: 2013-03-19
Enrollment: 805
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this project is to evaluate the efficacy of a 9-month Family Child Care Home (FCCH)-based intervention, Keys to Healthy Family Child Care Homes, to increase the physical activity and improve the diet quality of children (1.5 to 4.9 years).

Detailed description: Childhood obesity is a major public health problem and an important predictor of obesity later in life. Although early childhood is a formative period for dietary and activity habits, little research targeting this young age group has been conducted. Child care facilities are a prime setting for interventions targeting young children, given the number of families using some form of out-of-home care. Family child care homes (FCCH) are a particular type of child care facility in which the provider cares for children out of his/her own residence. FCCHs are generally less regulated than child care centers, and a significant percentage do not meet established recommendations for physical activity and nutrition practices. While there is a great need to intervene in these settings, there has been only one other published obesity prevention intervention in FCCHs to date. Interventions targeting FCCH providers could help promote healthy child weight by creating child care environments that provide and support active play opportunities and healthy food choices, while helping providers become role models for healthy lifestyles (physical activity and diet). However, the child care industry is faced with many challenges, including limited profitability. By incorporating strategies for overcoming some of these economic challenges, interventions may be able to more easily address barriers to implementing and sustaining the changes needed to promote regular physical activity and healthy dietary intakes in children.

This project will use a cluster-randomized controlled trial (RCT) to test the efficacy of the 9-month intervention, Keys to Healthy Family Child Care Homes, which targets FCCHs. Keys will be delivered in three modules which are designed to promote (1) provider health and providers as healthy role models, (2) physical activity- and nutrition-supportive environments at the FCCH, and (3) healthy business practices. Each module will be delivered via group workshops, on-site visits and phone contacts using Motivational Interviewing-inspired coaching and educational toolkits. By combining these components, the ultimate objective is to create healthy and stable FCCHs that promote healthy physical activity and eating behaviors in children.

The project will recruit and randomize 165 FCCHs (83 per arm). At each FCCH, subjects will include one child care provider and 3 children (we are targeting children between the ages of 1.5 and 4 years old, but one to two additional children who are younger than 18 months may also take part in height and weight measurements only). These 165 FCCHs and 825 children (495 children ages 1.5-4.9 years old and 330 children ages younger than 18 months) will be recruited in five waves over the course of 3 years, each wave enrolling 30 or more FCCHs (half assigned to each study arm). For recruitment, we will target areas with lower income households and with higher prevalence of child overweight/obesity within a 100 mile radius of the University of North Carolina at Chapel Hill (UNC) and Duke University. For each wave, potential FCCHs will be identified through the online database of licensed programs provided by the North Carolina Division of Child Development and Early Education (http://ncchildcaresearch.dhhs.state.nc.us/search.asp). Trained project staff will contact potential FCCH providers by mail/email (informational flyer/packets), telephone, and promotion at local professional meetings and community events. Informed consent will be obtained from providers and parents of participating children. Data collection will occur before and after the 9-month intervention, and each participating child care provider will receive up to $200 for completion of measures at both time points. At follow-up, we will also recruit newly enrolled children between the ages of 1.5 and 5 years old (one or two per home, thus about 210 additional children) to take part in all measures to allow additional cross-sectional analysis.

Increased child physical activity and improved quality of child diet while at the FCCH will be the primary outcomes used to assess the impact of this innovative, theory-driven intervention. Secondary outcomes and mediators include child body mass index, provider body mass index, provider weight-related behaviors (dietary intake and physical activity), provider motivation, self-efficacy and social support, and obesogenic (nutrition- and physical activity-related) environmental characteristics of the FCCH (including policies, practices and communication between providers and parents). Primary analyses for primary aims will involve testing each of these hypotheses under the intent-to-treat principle using Generalized Linear Mixed Models (GLMM) that will account for the correlation induced by the clustering of children within FCCHs. Statistical analysis will employ Statistical Analysis System (SAS).

Eligibility criteria: Inclusion Criteria:

* FCCH must have at least 2 children between the ages of 1.5 and 4 years currently enrolled. \* At least 2 children/families must agree to take part for the FCCH to remain eligible. (Note: Children ages 0-17 months may take part in height and weight measurements only)
* FCCH must have been in business for at least 2 years.
* FCCH must have a working telephone number.
* Provider must be able to read and speak English.

Exclusion Criteria:

* FCCHs cannot serve exclusively special needs children.
* FCCHs cannot close down during the summer months.

Primary outcomes:
measure: Change in Child Physical Activity
timeFrame: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.
measure: Change in Child Dietary Intake
timeFrame: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.
Secondary outcomes:
measure: Change in Child Body Mass Index
timeFrame: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.
measure: Change in Provider Physical Activity
timeFrame: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.
measure: Change in Provider Dietary Intake
timeFrame: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.
measure: Change in Provider Body Mass Index
timeFrame: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.
measure: Change in Provider Motivation for Providing Children with Physical Activity and Healthy Eating Opportunities
timeFrame: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.
measure: Change in Provider Self-Efficacy for Physical Activity and Healthy Eating
timeFrame: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.
measure: Change in Provider Social Support
timeFrame: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.
measure: Change in Physical Activity- and Nutrition-Related Environmental Characteristics of Family Child Care Home
timeFrame: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.
measure: Change in Child Waist Circumference
timeFrame: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.
Other outcomes:
measure: Change in Provider Sleep Index Score
timeFrame: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.
measure: Change in Provider Perceived Stress
timeFrame: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.
measure: Provider Physical Activity Readiness
timeFrame: Baseline only will be collected over a 2-month period prior to initiating a 9 month intervention.
measure: Change in Business Practices of the FCCH
timeFrame: Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.
Locations:
city: Chapel Hill
country: United States
facility: Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Dianne S Ward, EdD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Truls Ostbye, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ward DS, Vaughn AE, Burney RV, Hales D, Benjamin-Neelon SE, Tovar A, Ostbye T. Keys to healthy family child care homes: Results from a cluster randomized trial. Prev Med. 2020 Mar;132:105974. doi: 10.1016/j.ypmed.2019.105974. Epub 2019 Dec 30.
citation: Vaughn AE, Mazzucca S, Burney R, Ostbye T, Benjamin Neelon SE, Tovar A, Ward DS. Assessment of nutrition and physical activity environments in family child care homes: modification and psychometric testing of the Environment and Policy Assessment and Observation. BMC Public Health. 2017 Aug 29;17(1):680. doi: 10.1186/s12889-017-4686-9.