NET-Works:Community Preschooler Obesity Prevention
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The goal of the Minnesota center is to integrate primary care, home, and community-based
      intervention strategies to promote sustained patterns of change in food intake, physical
      activity, and body weight among low income, ethnically diverse children. A culturally matched
      family connector will create linkages among the settings to support parents in making home
      environment and parenting behavior changes conducive to healthy growth and development in
      their children.

      Specific Aim 1 To evaluate the effects of a three-year multi-setting parent-targeted
      randomized controlled intervention on the primary outcome, child BMI, compared to a standard
      primary care-only intervention among 500 low income ethnic minority two to four year old
      children who are at or above the 50th percentile of BMI for age and gender.

      Hypothesis 1: Children in the multi-setting parent-targeted intervention will have a lower
      BMI at 24 and 36 months, compared with children in the standard primary care only control
      group.

      Specific Aim 2 To evaluate the effects of a three-year multi-setting parent-targeted
      intervention on secondary outcomes, including change in child energy intake and physical
      activity energy expenditure, compared to a standard primary care-only intervention.

      Hypothesis 2: Children in the multi-setting parent-targeted intervention will have lower
      energy intake and higher energy expenditure over the three-year period, compared with
      children in the standard primary care-only control group.

      Specific Aim 3 To evaluate the effects of the multi-setting parent-targeted intervention on
      hypothesized mediators of change in dietary intake, physical activity, and BMI.

      Hypothesis 3: It is hypothesized that changes in parenting behaviors and the home food and
      physical activity environment will mediate changes in child energy intake and expenditure,
      and body mass index (BMI).
    

Detailed description: 
      1. Trial design overview NET-Works is a two-arm, randomized controlled trial to test the
           efficacy of a multi-setting, multi-component intervention approach to preventing obesity
           among racially/ethnically diverse preschool age children. The NET-Works intervention
           includes four main components: 1) a pediatric primary care brief counseling
           intervention; 2) a home-based intervention delivered by NET-Works family connectors to
           support parents in making changes in the home environment and parenting practices to
           promote healthful eating and activity patterns; 3) community-based parenting classes
           designed to parallel the home-based intervention curriculum and provide social support
           to participating parents; and 4) linkages to neighborhood and community resources to
           support parents in promoting healthful eating and activity patterns for their children.
           Five hundred parent/child dyads were randomized to either the NET-Works intervention or
           a usual care comparison condition and followed for three years. Participants were
           assessed at baseline and annually. The primary hypothesis is that children randomized to
           the NET-Works intervention will have lower BMI (body mass index) at two and three years
           post-randomization relative to usual care comparison group children. BMI is the primary
           outcome across all four Childhood Obesity Prevention and Treatment Research (COPTR)
           trials. Recruitment for the trial began in July 2012 and was completed in December 2013,
           with the final three year follow-up data collected in December 2016.

        2. Study setting and population The target population for NET-Works was racially/ethnically
           diverse preschool children and their parent or primary caregiver. To reach the intended
           population, NET-Works partnered with 12 primary care clinics and three managed health
           care systems that serve diverse populations with respect to race, ethnicity and income.
           Over 18 months, 500 families were recruited, enrolled and randomized to the intervention
           or to the usual care comparison group. Administrative databases and centralized
           electronic scheduling systems at the partner clinics provided data needed to target
           recruitment efforts on two-to-four year old children residing in certain zip code areas.
           The clinics had data from preventive care visits available for calculation of child body
           mass index (BMI) percentile to focus recruitment efforts on children who were
           potentially BMI-eligible for the study.

        3. Recruitment Administrative databases and centralized electronic scheduling systems at
           three partner health care organizations provided data needed to target families of
           two-four year old children whose BMI percentile was at or above the 50th percentile for
           age and gender. Clinic liaisons obtained approval from each child's pediatrician to send
           a study invitation letter to the parent or primary caregiver. A list of
           physician-approved potentially eligible children was shared with the NET-Works
           recruitment team. NET-Works sent the parent or primary caregiver a study invitation
           letter from the pediatrician and researchers. Approximately five working days later,
           NET-Works recruitment staff followed up by phone to provide more information, ask
           additional screening questions, and assesses parent/primary caregiver's interest in the
           study. If the parent/primary caregiver was interested and the child appeared to be
           eligible, a home visit for eligibility confirmation, consent, and data collection was
           scheduled. The purpose of this initial home visit was to: 1) explain and discuss the
           study, and begin to develop rapport with parents; 2) measure the index child's height
           and weight to confirm eligibility; 3) obtain informed consent; and 4) begin the process
           of collecting baseline data. Based on our pilot study experience, we anticipated the
           majority of the participating parent/caregivers would be female and a significant number
           of Hispanic families as well as non-Hispanic White, African American, and multi-race
           participants would be recruited.

        4. Randomization Prior to the start of recruitment and enrollment, the study statistician
           created 6 blocked randomization schedules, one for each age group (2, 3, 4) by gender
           (M, F) stratum, that would equally allocated children to the NET-Works intervention or
           the usual care comparison group in blocks of 10 to ensure equivalent study group size.
           Parent-child dyads were randomized to treatment and control conditions after completion
           of all baseline measures, including data eligibility requirements established by the
           COPTR consortium. Data eligibility requirements included valid height and weight
           measurement, a minimum of one weekday and one weekend day NDS-R (nutritional data
           survey-revised) previous day dietary recall and four days of valid accelerometry data.
           The study coordinator randomly assigned the participant to the condition shown in the
           next available slot in the stratum-appropriate pre-defined randomization schedule. The
           investigators and all assessment staff remained blinded to experimental assignment until
           after the final follow-up assessments were completed.

        5. NET-Works intervention The NET-Works intervention was designed to reach into the home
           and family environment to influence parent behaviors and attitudes to support changes in
           the home that affect food availability, family meals, television viewing, and active
           play. Each intervention component would be situated in community settings where parents
           and children already live their lives. The intervention was expected to be effective in
           part through taking advantage of the settings that families already inhabit, and through
           coordination across settings to reinforce and link the messages, resources and feedback
           families receive about healthful food choices, physical activity, and body weight for
           their child. We believed the neighborhood-based model would be more likely to enhance
           class participation, reduce transportation needs/costs, allow the local community
           resources to be accessed more easily, and foster outside-of-class interpersonal
           connections among parents for enhanced social support.

           5.1. Intervention components implementation overview The intervention curricula across
           each component (home visiting, parenting classes, neighborhood environment, pediatric
           primary care) was developed and refined during the pilot phase of the COPTR consortium.
           The intervention was designed to be implemented by trained research staff including a
           family connector who would conduct the home visiting and connector check-in calls and
           attend the parenting classes, and a parent educator who would conduct the community
           parenting classes that were based on the early childhood parenting class model and was
           developed in partnership with ECFE (early childhood and family education) in Minneapolis
           and St. Paul. The home visiting and parenting classes shared a common set of underlying
           curricula that included skills building around general parenting behaviors and the
           specific content behaviors targeted by the intervention (e.g., healthful snacks, family
           meals, physical activity). The family connector met parents and children in their own
           home, tailoring the intervention messages and strategies to best fit with the resources
           and motivations of parents. The family connector provided a one-on-one approach to
           synergize with the skills and strategies implemented in a group format in the NET-Works
           community parenting classes. Both home visiting and parenting classes directly connected
           parents to food and physical activity resources that already exist in their neighborhood
           ("community links"). Primary care providers bolstered these messages with parents during
           annual well-child visits.

           5.2. Home visiting The goal of the home visiting was to help parents develop parenting
           skills, set goals related to child healthful eating, active play and reduced television
           viewing, and provided support for sustaining and building on these behavior and home
           environment changes. The dose for the home visiting intervention component was one visit
           per month for each of the three years. The family connector built a collaborative,
           partnership-based goal setting process for parents to facilitate child behavior change.
           Facilitation of the home visits was modeled on Motivational Interviewing, an approach
           designed to help individuals explore and resolve ambivalence about behavior change in a
           non-confrontational manner. Home visiting included a goal setting process guided by the
           family connector, healthful action activities to create norms and skills related to the
           targeted behaviors, and resources for links in the community to support healthful
           behaviors. Family connectors also checked in with participants to review progress on
           goals and provide support in between home visits. Family connector check-in contacts
           could be conducted over the telephone or via email. Family connectors had weekly
           supervision sessions with a licensed mental health provider with expertise in
           Motivational Interviewing to review progress with each participant, problem solve
           regarding any challenges that arise, and ensure adherence to the intervention protocol.

           5.3. Parenting classes The parenting classes were designed to work synergistically with
           the home visiting curriculum. The parenting class and the home visiting curriculum both
           included topics that addressed parenting skills development, the home food environment,
           healthful eating, family meals, television viewing limits, active play, and goal
           setting. The parenting class provided a group format where parents could share their
           experiences, gain support from other parents and learn from each other. The curriculum
           was research-based and facilitated by a trained parent educator. The dose for the
           parenting class component was 12 classes per year for each of the three years. The
           curriculum in years 2 and 3 built upon and deepen the topics introduced in year 1, and
           addressed parenting and developmental issues as children progress from ages 2-7 years of
           age. Parent educators also participated in weekly supervision sessions to ensure
           adherence to the intervention protocol.

           5.4. Neighborhood and community initiative The purpose of the neighborhood and community
           intervention component was to increase access to, and use of, healthful food, physical
           activity, and school readiness resources available in the neighborhood communities where
           study participants live. Parents were directly linked with resources in their
           neighborhood through both the parenting classes and the family connector home visits.
           Community initiatives implemented with the family connector included conducting a
           walkability assessment of the family's neighborhood. The family connector reviewed
           neighborhood food and physical activity resources with the parent at each home visit,
           and encouraged them to use these resources to support their home and behavior changes.
           The community links included one school readiness community activity (e.g., a library
           visit) to promote developmental parenting, sustain parent interest, and provide active
           support for whole child development. Four community links were included in the parenting
           class and home visiting curriculum each year of the intervention.

           5.5. Primary care The primary care provider is an influential connection for parents. In
           NET-Works, the primary care provider delivered key messages around parent behaviors for
           shaping, reinforcing and sustaining healthful child eating and physical activity
           behaviors and body weight. To support providers in delivering key messages to parents
           during well child visits, a brochure was developed in partnership with the participating
           clinic systems. The brochure was used by the primary care provider to converse about
           child BMI percentile and strategies parents could use to promote their child's healthful
           eating and activity patterns. The NET-Works family connector will also provided
           information about progress on intervention goals to the primary care provider on an
           annual basis to reinforce continuity and integration of intervention messages. The
           primary care intervention linked with the community parenting classes and home visiting
           to deliver consistent intervention messages over a sustained time period.

        6. Intervention component integration Linkages across the intervention components were
           created in several ways with the family connector playing a key role in this
           connectivity. Specifically, in addition to conducting home visits, family connectors
           facilitated participant entry into parenting classes and also attended parenting
           classes. Attending parenting classes allowed the family connector to be knowledgeable
           about the parenting class content and the experience their assigned participants were
           having during class. This information informed the goal setting that family connectors
           and parents worked on during home visits. Family connectors also served as the liaison
           between parents and primary care providers. The home visits and parenting classes also
           incorporated connections to community resources for physical activity and healthy eating
           as described above.

        7. Usual care comparison group The usual care comparison group received the primary care
           provider component described above, and quarterly newsletters with information about
           their child's general health and wellness and school readiness.

        8. Participant timeline, assessments, and measures Data collection took place in the home
           setting at baseline, 12, 24, and 36 months by trained and certified, bilingual English
           and Spanish research specialists, blinded to experimental assignment. At 6, 18, and 30
           months, a brief telephone survey was conducted. Participants receive a total of $50 in
           gift cards for each set of measurement visits (baseline and each subsequent annual
           assessment) and a $5 gift card for each brief telephone survey. Data collectors were
           trained by the investigators and, for COPTR consortium common measures, by the Research
           Coordinating Unit (RCU) according to standardized protocols. COPTR used a
           train-the-trainer model. "Master Trainers" who participated in a central training
           organized by the RCU were responsible for training and certifying the data collection
           staff at their field center. Data collectors were required to demonstrate high inter-
           and intra-rater reliability prior to data collection.

        9. Statistical analyses The primary efficacy analysis was designed to test whether two to
           four year old children who were randomized to the NET-Works program have statistically
           and clinically lower BMI at 24 and 36 months post randomization relative to usual care
           comparison group children with age at randomization (2, 3, 4), sex (F, M) and BMI at
           baseline used as covariates. According to the study protocol, all covariates in the
           primary analysis would be measured at baseline prior to randomization and therefore
           available for observed and unobserved BMI values.

       10. Data monitoring and participant safety The data safety and monitoring plan included
           assessing adverse events systematically at each data collection visit with direct
           queries for all injuries, illnesses or other medical problems requiring a visit to a
           medical care provider and related to participation in the study. Serious Adverse Events
           (SAEs) were specifically monitored. Adverse events were also be recorded and evaluated
           when they came to the attention of study staff between the data collection visits. An
           independent Data and Safety Monitoring Board was selected to review study protocols and
           provide oversight of recruitment and study progress, data quality and completeness, and
           participant safety.
    

Intervention name(s): multi-component/setting parent-targeted intervention
Intervention type(s): Behavioral
Intervention description(s): parents assigned to this group will be asked to participate in a program of home visiting, community parenting classes, and community food and physical activity resource links
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: preschooler obesity prevention; community home visiting parents; preschooler excess BMI gain; multi-setting/component intervention