Feasibility Study of the Modified-Smart and Secure Children Program in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Increase in Healthy Food Dietary Patterns
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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:
研究组 & 干预措施
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.
干预措施: SSC Program (Behavioral)
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.
干预措施: Written Handouts (Behavioral)
结局指标
主要结局
Increase in Healthy Food Dietary Patterns
时间窗: 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
次要结局
- Decrease in Parental Stress(5 months)
- Parental Mental Health Improvement(5 months)
- Improvement in Parental Feeding Behaviors(5 months)
研究者
Ashley Butler
Assistant Professor
Baylor College of Medicine