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Smart and Secure Children Program for Preschool Obesity (SSC)

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ClinicalTrials.gov Identifier: NCT02681874
Recruitment Status : Active, not recruiting
First Posted : February 15, 2016
Last Update Posted : July 10, 2019
Sponsor:
Collaborators:
Texas Children's Hospital
University of Houston
Information provided by (Responsible Party):
Ashley Butler, Baylor College of Medicine

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.


Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Behavioral: SSC Program Behavioral: Written Handouts Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of the Modified-Smart and Secure Children Program in Primary Care
Study Start Date : December 2015
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. Increase in Healthy Food Dietary Patterns [ Time Frame: 5 months ]
    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 :
  1. Decrease in Parental Stress [ Time Frame: 5 months ]
    Parent perceived general stress will be assessed using the Perceived Stress Scale.

  2. Decrease in Parental Stress [ Time Frame: 5 months ]
    Parent perceived parenting stress will be assessed using the Parenting Stress Index-Short Form.

  3. Decrease in Parental Stress [ Time Frame: 5 months ]
    Diurnal cortisol rhythm levels will be determined by obtaining samples of parents' saliva.

  4. Parental Mental Health Improvement [ Time Frame: 5 months ]
    The Center for Epidemiological Depression Studies Scale will be used to determine parental depressive symptoms.

  5. Parental Mental Health Improvement [ Time Frame: 5 months ]
    The Mental Health Continuum-Short Form will be used to measure parents' positive mental health symptoms.

  6. Improvement in Parental Feeding Behaviors [ Time Frame: 5 months ]
    Parental feeding behaviors will be assessed using The Child Feeding Questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02681874


Locations
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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Texas Children's Pediatric Associates (TCPA)
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Texas Children's Hospital
University of Houston
Investigators
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Principal Investigator: Ashley Butler, Ph.D Baylor College of Medicine

Additional Information:
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Responsible Party: Ashley Butler, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02681874     History of Changes
Other Study ID Numbers: H-37460
46486-I ( Other Grant/Funding Number: Texas Children's Hospital Pediatric Pilot Award )
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ashley Butler, Baylor College of Medicine:
dietary pattern
stress
nutrition
health
obesity
children
minority
pre-schoolers

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms