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Smart and Secure Children Program for Preschool Obesity (SSC)

11. April 2022 aktualisiert von: Ashley Butler, Baylor College of Medicine

Feasibility Study of the Modified-Smart and Secure Children Program in Primary Care

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

35

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77030
        • Texas Children's Hospital
      • Houston, Texas, Vereinigte Staaten, 77030
        • Texas Children's Pediatric Associates (TCPA)

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

2 Jahre bis 5 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: 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.
Aktiver Komparator: 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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Increase in Healthy Food Dietary Patterns
Zeitfenster: 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
5 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Decrease in Parental Stress
Zeitfenster: 5 months
Parent perceived general stress will be assessed using the Perceived Stress Scale.
5 months
Decrease in Parental Stress
Zeitfenster: 5 months
Parent perceived parenting stress will be assessed using the Parenting Stress Index-Short Form.
5 months
Decrease in Parental Stress
Zeitfenster: 5 months
Diurnal cortisol rhythm levels will be determined by obtaining samples of parents' saliva.
5 months
Parental Mental Health Improvement
Zeitfenster: 5 months
The Center for Epidemiological Depression Studies Scale will be used to determine parental depressive symptoms.
5 months
Parental Mental Health Improvement
Zeitfenster: 5 months
The Mental Health Continuum-Short Form will be used to measure parents' positive mental health symptoms.
5 months
Improvement in Parental Feeding Behaviors
Zeitfenster: 5 months
Parental feeding behaviors will be assessed using The Child Feeding Questionnaire.
5 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Baylor College of Medicine

Mitarbeiter

University of Houston

Ermittler

  • Hauptermittler: Ashley Butler, Ph.D, Baylor College of Medicine

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Dezember 2015

Primärer Abschluss (Tatsächlich)

1. Dezember 2017

Studienabschluss (Tatsächlich)

1. April 2022

Studienanmeldedaten

Zuerst eingereicht

13. Januar 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Februar 2016

Zuerst gepostet (Schätzen)

15. Februar 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. April 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. April 2022

Zuletzt verifiziert

1. April 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • H-37460
  • 46486-I (Andere Zuschuss-/Finanzierungsnummer: Texas Children's Hospital Pediatric Pilot Award)

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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