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临床试验/NCT02343341
NCT02343341已完成不适用

Family-based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health (FAMILIA)

Icahn School of Medicine at Mount Sinai15 个研究点 分布在 1 个国家目标入组 562 人开始时间: 2015年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
562
试验地点
15
主要终点
Change in children's Knowledge, attitude, habit (KAH) scores

研究概览

简要总结

Problem: Childhood obesity has more than doubled over the past 30 years, with nearly one-third of children aged 6 to 11 years being obese. These children are more likely to become obese adults and are at a higher risk for the development of diabetes, hypertension, heart disease and cancer.

Approach: This research tests the hypothesis that habits are formed very early in life and that children can help their parents live healthier lives. The investigators attempt to test this hypothesis by evaluating the impact of an educational program focusing on diet, physical activity, knowledge of the human body, and management of emotions for preschool children aged 3 to 5 years, their parents/caregivers and teachers. The investigators will first assess the environmental factors, facilitators, and barriers to implementation of a health promotion educational program tailored for preschoolers in Harlem, New York. This information will be used to tailor the educational program for the children in Harlem. The investigators will evaluate the effectiveness of the program in children aged 3 to 5 years by randomly assigning blocks of schools to a 4-month educational and playful health promotion intervention or to usual curriculum. The program will also have components for teachers and parents of these children in order to make their learning environment conducive to positive change. The impact of our program will be assessed on children's knowledge, attitudes, habits, weight, exercise and diet using simple questionnaires and measurements.

Impact: The investigators expect to demonstrate a positive impact on knowledge, attitudes and habits in preschool children in an under-served population. Also aim is to demonstrate that this early educational program can increase the proportion of preschool aged children with normal weight. This approach has the potential to meaningfully modify the projected rise in obesity and cardiovascular disease by affecting an entire generation of children. The investigators believe that the healthy habits that the children will acquire through this program will lead them to be healthier adults. Thus, the mission aligns closely with the American Heart Association's mission of, "Building healthier lives, free of cardiovascular diseases and stroke".

详细描述

Aim 1- Pilot: In the 1-year initial pilot period, the investigators will identify the contextual factors, facilitators and barriers that may impact the implementation of a preschool-based health promotion educational program in Harlem, using qualitative research methods: 1) focus group discussions among teachers; 2) focus group discussions among community leaders; and 3) focus group discussions among parents of preschool-aged children.

Subsidiary Aim 1.1: To use identified facilitators and barriers to develop a contextually and culturally appropriate model for a preschool-based health promotion educational program.

Subsidiary Aim 1.2: To implement a pilot intervention of the contextually and culturally adapted program at two preschools in Harlem. The investigators will assess for acceptability and feasibility, and make any necessary modifications prior to the implementation of the cluster-randomized trial.

Aim 2- Randomization: To evaluate the effectiveness of the preschool-based health promotion educational program on KAH-BEA: knowledge (K), attitudes (A), habits (H), BMI Z score (B), exercise (E) and Alimentation (A)(KAH-BEA) of approximately 600 preschool children, using a composite questionnaire-based score (KAH score) measuring the parameters related to the domains of diet, physical activity, health of the body and heart, and management of emotions, and weight and physical activity.

The investigators hypothesize that preschool children receiving the health promotion educational program will demonstrate a higher composite KAH score than controls.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
3 Years 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Fifteen preschools comparable in characteristics related to socio-economic level and ethnicity with the following criteria:
  • The schools must be located in Harlem, NY;
  • The schools must be public;
  • The schools must have children 3, 4 and 5 years of age;
  • The schools must provide meals for the children.
  • The schools must make available use of their applicable program operation space.

排除标准

  • Participation in any other major structured health intervention program similar to the FAMILIA Program during the evaluation of the program
  • Inability to carry out all activities proposed by the FAMILIA Program

研究组 & 干预措施

Preschool Health Promotion Education Program

Experimental

Children randomized to the intervention arm will receive a 4-month health promotion education program along with their parents/caregivers and teachers.

干预措施: Preschool Health Promotion Education Program (Behavioral)

Control:Standard Curriculum

Other

The Standard curriculum control arm will receive the standard curriculum in their schools.

Children randomized to the control arm will receive the health promotion education program for 4 months after the intervention arm has completed it

干预措施: Preschool Health Promotion Education Program (Behavioral)

结局指标

主要结局

Change in children's Knowledge, attitude, habit (KAH) scores

时间窗: baseline and 5 months

The mean change in KAH scores at immediate post-intervention (approximately 5 months) as compared to baseline.

次要结局

  • Change in children's Knowledge, attitude, habit (KAH) scores(baseline and 24 months)
  • Change in children's BMI Z score, Exercise, and Alimentation (BEA) scores(baseline and 24 months)
  • Change in children's Test of Emotion Comprehension scores(baseline and 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (15)

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