Extension Family Lifestyle Intervention Project (E-FLIP for Kids)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 2
- 主要终点
- Child BMI Z score
研究概览
简要总结
The Extension Family Lifestyle Intervention Project (E-FLIP for Kids) trial will evaluate the impact of a community based intervention delivered to families in rural settings utilizing the existing Cooperative Extension Service network on child dietary intake and weight. Specifically, the E-FLIP for Kids study will determine if behavioral treatments for child obesity lead to greater improvement in child weight compared to educational only treatment.Participants will include 240 parent-child dyads from ten rural counties in north central Florida. Study outcomes will be measure prior to treatment, at the end of treatment (month 12) and at one year follow-up (month 24). All treatment meetings will be held at Cooperative Extension Service offices within each participating county.
详细描述
The study sample will include 240 overweight and obese children, ages 8 to 12 years, and their parent(s) from rural counties in North Central Florida. Participants will be randomized to one of three conditions: family-based (FB) healthy lifestyle intervention, parent-only (PO) healthy lifestyle intervention, and health education control (HEC) condition. Each of the treatment conditions will involve 23 group meetings delivered on the same schedule.
Recruitment will include direct solicitation methods combined with culturally-tailored efforts targeting the recruitment of minority participants. Direct solicitation methods will entail direct mailings to households and to health-care providers, a press release, and presentations/brochure distribution by Extension agents and research team members at churches, social organizations, community events, and through local businesses. Brochures will also be distributed through local schools. Recruitment information will contain a toll-free phone number to our research office. Potential participants will be encouraged to call our office to learn more about the study and complete an initial phone screen. The phone calls will be received by trained staff that will describe the study and perform a brief phone screen in order to determine initial eligibility. Those families who meet initial eligibility and express interest will be scheduled for an in-person screening visit to determine their final eligibility for the program.
Participants (child and parent) will complete assessment measures at an initial screening visit, pre-start baseline assessment, post-treatment assessment (12 months after the baseline assessment), and a follow-up assessment (24 months after the baseline assessment).
At the initial in-person screening visit interested participants (child and parent/legal guardian) will complete informed consent procedures and then measures of height and weight, medical history questionnaires, and a general family information form. Parents will complete questionnaires regarding family functioning, parent psychological functioning, parent mobility, child behavior, reasons for seeking treatment, and family cost of program participation. Children will complete questionnaires regarding reasons for joining the program and social interactions. In addition, the child will be assessed for resting heart rate and blood pressure.
The pre-start/baseline assessment visit will occur approximately one to two weeks prior to the beginning of the intervention. At this assessment children and parents will be measured for height and weight, and the child's waist circumference will also be assessed. Families will complete a packet of self-report study questionnaires. Children will be assessed for blood pressure and heart rate. Children's body fat percentage will be assessed by an electrical impedence scale. Child will be asked to wear an armband accelerometer for seven days following the assessment. Children will also be asked to complete one finger prick (with collection of approximately 2-3 drops of blood) to assess blood lipids and HbA1C using a point-of-care device. A 20 meter shuttle physical fitness assessment will also be completed by children to assess their level of physical fitness. The finger prick, blood pressure, physical fitness, and heart rate assessment protocol will be completed by study medical personnel trained in these procedures. Children, with help from their parents, will complete measures of the child's dietary intake and physical activity habits, eating behaviors, qualify of life, body image, and pubertal development. Parents will complete measures about their own dietary intake and physical activity habits, the family feeding environment, perceive family support and social problem solving abilities. At the end of this baseline assessment visit, participants will be notified as to which of the three treatment conditions they were randomized.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 8 and 12 years,
- •BMI equal to or above the 85th percentile for age and gender
- •Child and participating parent(s) or legal guardian(s) are required to live within the same dwelling in a rural county.
- •Participating parents or legal guardians must be age 75 years or less.
排除标准
- •Child or participating parent has a dietary or exercise restriction
- •Medical condition that contraindicates mild energy restriction or moderate physical activity
- •Children or adults cannot be engaged in another weight control program.
- •Unwilling or unable to give informed consent,
- •Parent(s) or legal guardian(s) unable to read English at approximately the 5th grade level,
- •Unwilling to accept random assignment,
- •Unable to travel to the Extension office for intervention sessions,
- •Likely to move out of the county within the next 24 months.
结局指标
主要结局
Child BMI Z score
时间窗: 2 years
Change in Child BMI Z score from baseline to year 2
次要结局
- Child caloric intake(2 years)
- Child Physical Activity(2 years)
