Smart and Secure Children Program for Preschool Obesity
Condition: Obesity; Type 2 Diabetes
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Many behavioral interventions designed to improve dietary patterns for ethnic and
      racial/minority preschoolers have produced modest outcomes. A limitation of these
      interventions include a failure to address key factors associated with dietary patterns for
      these children, such as parental stress levels. Therefore, the identification of intervention
      models that target these factors and are effective, acceptable, and feasible among parents of
      young minority children is important.

      Subjects will be asked to take part in this study because they are the parents of a child
      that receives care at a Texas Children's Pediatrics (TCP) clinic where the study is being
      done and their child's body mass index has been at or above the 85th percentile.

      The purpose of this pilot study is to assess the ease and acceptance of providing an
      intervention for parents of children ages 2-5 years in the pediatric primary care clinic. The
      purpose is to also assess how well the intervention works in improving the child's dietary
      patterns.
    

Detailed description: 
      Thirty (30) subjects will be enrolled across three (3) TCP clinics where the study will take
      place. Two types of participants will be recruited for this study: parent participants who
      will receive the intervention and interventionist participants who will deliver the
      intervention.

      Data collected for this study includes 4 types: parent-report questionnaires, parent saliva
      samples, parent-report of children's 24-hour food recall, and audio-recordings of
      intervention sessions. Parent-report questionnaires will assess family demographic
      information, parental stress, depression, and well-being as well as parental feeding
      practices and child dietary food patterns.

      Procedures for Parent Participants:

      Parents will be randomized to the intervention (Group A-15 parents) or control condition
      (Group B-15 parents). Parents who are randomized to the intervention group will then
      participate in the 10-session SSC program that is co-led by a trained parent interventionist.
      Sessions will be audio-recorded to allow intervention fidelity checks. Parents who are
      randomized to the control condition will receive the SSC written handouts, which is enhanced
      standard of care for parents who are seen in primary care.

      If subjects are assigned to Group A, they will participate in ten intervention sessions that
      are conducted in the TCP clinic. During each session, subjects will be provided with
      information about specific skills to improve their child's emotional health and dietary
      patterns and their own stress levels.

      If subjects are assigned to Group B, they will receive written handouts about children's
      dietary patterns and parent stress levels. They will be instructed to write goals and
      document goal progress. This care plan is the standard practice and is presently implemented
      in the site's TCP clinics.

      After ten weeks, regardless of the group the subjects were assigned to, they will again
      complete an interview about their child's dietary food patterns and questionnaires about
      their own emotions/opinions of their parenting and child feeding practices. The subjects will
      also be asked to collect their saliva at four time points on a single day at home.

      Procedures for Interventionist Participants:

      Six interventionist participants will be recruited. Those who indicate interest will meet
      with the PI or a research staff member to obtain consent. They will then receive 40-hours of
      training in the intervention provided by study staff. Intervention participants will deliver
      one or more group intervention, which has 10 sessions.
    

Intervention name(s): SSC Program; Written Handouts
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Smart and Secure Children (SSC) program is a 10-week manualized intervention that uses a written validated curriculum. The program is group-based and co-led by peer leaders (Parent Leaders). Parent Leaders facilitate conversations on the SSC program content by sharing real life application, experiences, and solutions.; The handouts are a part of the SSC program that include didactic curriculum content and instruct parents to write goals and document goal progress.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dietary pattern; stress; nutrition; health; obesity; children; minority; pre-schoolers