Smart and Secure Children Program for Preschool Obesity

NCT ID: NCT02681874

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2022-04-30

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.

Conditions

Obesity; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (Treatment Arm)

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.

Group Type: EXPERIMENTAL

SSC Program

Intervention Type: 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 B (Control Arm)

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.

Group Type: ACTIVE_COMPARATOR

Written Handouts

Intervention Type: 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.

Interventions

SSC Program

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.

Intervention Type: BEHAVIORAL

Written Handouts

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Houston

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ashley Butler

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashley Butler, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas Children's Hospital

Houston, Texas, United States

Texas Children's Pediatric Associates (TCPA)

Houston, Texas, United States

Countries

United States

Related Links

http://www.texaschildrens.org/find-a-doctor/ashley-michelle-butler-phd

Dr. Butler's Profile Page

Other Identifiers

46486-I

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-37460

Identifier Type: -

Identifier Source: org_study_id