Smart and Secure Children Program for Preschool Obesity

NCT02681874 | Completed

• 2 other identifiers: H-3746046486-I
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity; Type 2 Diabetes

Keywords

dietary pattern; stress; nutrition; health; obesity; children; minority; pre-schoolers

Outcome Measures

Primary Outcomes (1)

• Increase in Healthy Food Dietary Patterns

  24-hour recalls conducted with parents will be used to assess children's intake of vegetables, fruits, whole grains, and low/non-fat dairy

  5 months

Secondary Outcomes (6)

• Decrease in Parental Stress

  5 months

• Decrease in Parental Stress

  5 months

• Decrease in Parental Stress

  5 months

• Parental Mental Health Improvement

  5 months

• Parental Mental Health Improvement

  5 months

Study Arms (2)

Group A (Treatment Arm)

EXPERIMENTAL

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). Sessions are 90 minutes. Groups consist of a maximum of five parents. Parent Leaders facilitate conversations on the SSC program content by sharing real life application, experiences, and solutions. Parent Leaders receive a week-long leadership training to deliver the program and will be supervised by the PI who is a licensed clinical psychologist.

Behavioral: SSC Program

Group B (Control Arm)

ACTIVE COMPARATOR

Parents in the control condition will receive the Smart and Secure Children (SSC) program's written handouts. Handouts include didactic curriculum content and instruct parents to write goals and document goal progress.

Behavioral: Written Handouts

Interventions

SSC Program BEHAVIORAL

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.

Group A (Treatment Arm)

Written Handouts BEHAVIORAL

The handouts are a part of the SSC program that include didactic curriculum content and instruct parents to write goals and document goal progress.

Group B (Control Arm)

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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
• None

Sponsors & Collaborators

• Baylor College of Medicine: lead
• University of Houston: collaborator

Study Sites (2)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Texas Children's Pediatric Associates (TCPA)

Houston, Texas, 77030, United States

Location

Related Links

• Dr. Butler's Profile Page

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ashley Butler, Ph.D

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: February 15, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)