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Smart and Secure Children Program for Preschool Obesity (SSC)

Primary Purpose

Obesity, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SSC Program
Written Handouts
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring dietary pattern, stress, nutrition, health, obesity, children, minority, pre-schoolers

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Children's Hospital
  • Texas Children's Pediatric Associates (TCPA)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A (Treatment Arm)

Group B (Control Arm)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Decrease in Parental Stress
Parent perceived general stress will be assessed using the Perceived Stress Scale.
Decrease in Parental Stress
Parent perceived parenting stress will be assessed using the Parenting Stress Index-Short Form.
Decrease in Parental Stress
Diurnal cortisol rhythm levels will be determined by obtaining samples of parents' saliva.
Parental Mental Health Improvement
The Center for Epidemiological Depression Studies Scale will be used to determine parental depressive symptoms.
Parental Mental Health Improvement
The Mental Health Continuum-Short Form will be used to measure parents' positive mental health symptoms.
Improvement in Parental Feeding Behaviors
Parental feeding behaviors will be assessed using The Child Feeding Questionnaire.

Full Information

First Posted
January 13, 2016
Last Updated
April 11, 2022
Sponsor
Baylor College of Medicine
Collaborators
University of Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02681874
Brief Title
Smart and Secure Children Program for Preschool Obesity
Acronym
SSC
Official Title
Feasibility Study of the Modified-Smart and Secure Children Program in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
April 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
University of Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes
Keywords
dietary pattern, stress, nutrition, health, obesity, children, minority, pre-schoolers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (Treatment Arm)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B (Control Arm)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SSC Program
Intervention Description
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
Intervention Name(s)
Written Handouts
Intervention Description
The handouts are a part of the SSC program that include didactic curriculum content and instruct parents to write goals and document goal progress.
Primary Outcome Measure Information:
Title
Increase in Healthy Food Dietary Patterns
Description
24-hour recalls conducted with parents will be used to assess children's intake of vegetables, fruits, whole grains, and low/non-fat dairy
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Decrease in Parental Stress
Description
Parent perceived general stress will be assessed using the Perceived Stress Scale.
Time Frame
5 months
Title
Decrease in Parental Stress
Description
Parent perceived parenting stress will be assessed using the Parenting Stress Index-Short Form.
Time Frame
5 months
Title
Decrease in Parental Stress
Description
Diurnal cortisol rhythm levels will be determined by obtaining samples of parents' saliva.
Time Frame
5 months
Title
Parental Mental Health Improvement
Description
The Center for Epidemiological Depression Studies Scale will be used to determine parental depressive symptoms.
Time Frame
5 months
Title
Parental Mental Health Improvement
Description
The Mental Health Continuum-Short Form will be used to measure parents' positive mental health symptoms.
Time Frame
5 months
Title
Improvement in Parental Feeding Behaviors
Description
Parental feeding behaviors will be assessed using The Child Feeding Questionnaire.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Butler, Ph.D
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children's Pediatric Associates (TCPA)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.texaschildrens.org/find-a-doctor/ashley-michelle-butler-phd
Description
Dr. Butler's Profile Page

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Smart and Secure Children Program for Preschool Obesity

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