ST of TN-Salud Con La Familia: Prevent Onset of Ped Obesity
Condition: Diabetes; Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Preventing the onset of pediatric obesity and diabetes in Latino families

      The investigators will conduct a randomized controlled trial of a family-based community
      centered intervention. One-hundred Latino families with children ages 3-5 will be randomly
      allocated to either the intervention group (a 3-month skills building program to improve
      nutrition and aerobic activity for child-parent dyads) or a control group (literacy
      promotion). Through an active partnership with Nashville Metro Parks and Recreation and the
      Division of General Pediatrics at the Vanderbilt Children's Hospital, the investigators will:
      1) Implement an intervention for Latino families with young children that includes parent
      training, behavior modification training, nutrition education, and physical activity
      promotion; 2) Evaluate how this intervention affects growth trajectories in children; 3)
      Evaluate how this intervention affects parenting practices for Latino families to improve
      nutrition and physical activity; and 4) Evaluate the ability to link families into a
      pediatric medical home if they have none identified. By developing innovative family-focused
      interventions, finding solutions to health conditions such as obesity and diabetes could be
      realized-con la familia.
    

Detailed description: 
      Obesity is a well-known risk factor for the development of diabetes. Obesity rates have
      rapidly increased over the past three decades for all Americans and have doubled for
      children. Latino children experience obesity at disproportionate rates. The most promising
      obesity interventions have focused on having children partner with a parent to set goals.
      Latino cultural norms emphasizing family provide a unique opportunity to develop
      family-centered interventions.

      We will recruit 100 families (child-parent dyad) via a multi-pronged strategy including:
      provision of bilingual informational flyers; announcements on a Spanish radio program; and
      additional strategies developed by key community leaders in the Nolensville corridor. This
      recruitment approach has been successful for us in the past. Once recruited into the program,
      parent-child dyads will be randomly allocated to either the intervention group or control
      group (described below).

      Intervention Group

      Fifty (50) families will be randomly allocated to receive the Salud Con La Familia skills
      building curriculum at Coleman Community Center, which will include:

        1. Twelve (12) weekly 60-minute sessions in the recreation center (Refer to Table 1). The
           parent-child dyad will participate in 4 sessions from the En Sus Marcas curriculum,
           which was just tested by this study team (Barkin, PI). These sessions emphasize skills
           building around parenting, behavior modification, daily physical activity, and decreased
           sedentary activity. To this we will add 8 sessions from the Salud, Salsa, y Sabor25
           curriculum, a best-practice program to improve nutrition and energy balance for Latino
           families, designed by the National Latino Children's Institute (NLCI) but not yet
           utilized in Tennessee. The combination of these two promising curricula results in a
           comprehensive program that includes all ADA-recommended elements of effective
           interventions for pediatric overweight.23 All sessions will be led by the same bilingual
           facilitators to ensure maximum fidelity and minimal difference between the information
           provided to participants. While this program has been designed in active partnership
           with Nashville Metro Parks and Recreation, we are also currently conducting a listening
           tour with key informants from the Nolensville community to provide further input into
           the content and implementation of the Salud Con La Familia approach. Throughout,
           emphasis is placed on healthy lifestyles, not on weight loss or obesity.

        2. At the end of each session, the study team will facilitate creating a parent-child
           contract to develop concrete weekly goals around nutrition and physical activity. Such
           contracts are integral to behavior modification.26

        3. The study team will assess if families have an identified pediatric medical home and use
           this for preventive health visits. If no medical home is identified, the team will
           assist with this health connection.

      Control Group Fifty (50) families will be allocated to participate monthly with a literacy
      promotion skills-building curriculum. They will receive flyers when family events are offered
      at the community center. They will participate in data collection at the same time-points as
      the intervention families. Refer to Table 2 for our project timeline.

      Outcomes will include: growth trajectories, parenting practices, activity patterns, and link
      to medical home.
    

Intervention name(s): Lifestyle counseling
Intervention type(s): Behavioral
Intervention description(s): 3 month skills building program emphasizing parent training, behavior modification training, nutrition education, and physical activity promotion
Other intervention name(s): Salud con la familia
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Diabetes; Physical Activity; Child Feeding; Growth Trajectories; Family based