Clinical trial NCT02681874: Smart and Secure Children Program for Preschool Obesity
Official title: Feasibility Study of the Modified-Smart and Secure Children Program in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes
Keywords: dietary pattern
stress
nutrition
health
obesity
children
minority
pre-schoolers
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: University of Houston
First posted: 2016-02-15
Enrollment: 35
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria for Parent Participants:

* Non-Latino African American or Latino parents/primary caregivers (defined as primary guardian, which may include legal guardians and foster parents) of a child patient (ages 2-5 years) at Texas Children's Pediatrics (TCP) Community Care medical practices (Gulfgate, Cullen, and Corinthian Pointe)
* Parents of children with a body mass index (BMI) of greater than 85th and less than 95th percentile (overweight) and greater than 95th percentile (obese)
* English as the primary household language

Inclusion Criteria for Interventionist Participants:

* Non-Latino African American or Latino, 18 years or older, having a GED/high school diploma, and parent of a young child

Exclusion Criteria for Parent Participants:

* Parents of children with any type of food allergy, parents of children receiving current intervention for weight
* Parents of children with weight-related medical conditions (e.g., Prader-Willi Syndrome)
* Parents of children who are taking medication (e.g.,stimulant) associated with appetite

Exclusion Criteria for Parent Participants:

* None

Primary outcomes:
measure: Increase in Healthy Food Dietary Patterns
timeFrame: 5 months
Secondary outcomes:
measure: Decrease in Parental Stress
timeFrame: 5 months
measure: Decrease in Parental Stress
timeFrame: 5 months
measure: Decrease in Parental Stress
timeFrame: 5 months
measure: Parental Mental Health Improvement
timeFrame: 5 months
measure: Parental Mental Health Improvement
timeFrame: 5 months
measure: Improvement in Parental Feeding Behaviors
timeFrame: 5 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: Texas Children's Pediatric Associates (TCPA)
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Ashley Butler, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: