Family-Based Nutrition Intervention for Latino Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 307
- 主要终点
- Mean Change in Body Mass Index (BMI)
研究概览
简要总结
Primary Hypothesis Children whose mothers receive the FBC sessions will have significantly lower BMI one year after the intervention compared to control group children whose families receive an active placebo control.
Secondary Hypotheses In families that receive the FBC, household availability of fruits and vegetables will increase, and availability of high fat foods will decrease, as measured by multiple household food inventories, compared to control group families exposed to an active placebo intervention.
Household level of food security, mothers' food purchase motives and family food interaction will influence the effects of the FBC on household food supplies.
详细描述
BACKGROUND:
Cardiovascular disease accounted for 40.6% of deaths in the United States in 1998. Although CVD does not manifest until adulthood, risk factors for CVD, such as obesity, may develop in childhood and persist into adulthood. We propose to test the efficacy of an intervention designed to prevent obesity in low-income, Mexican American children. Mexican-American children are more obese than other minority groups in the U.S. population, and are the fastest growing minority group in the U.S.A. Poor dietary practices, especially food habits that are acquired as families acculturate to the American food supply, are thought to be associated with children's excess weight gain.
We propose to conduct a randomized clinical trial in which 150 families receive family-based behavioral counseling (FBC) sessions and 150 families receive an active placebo control intervention. Mothers and their second or third grade children from sixteen low-wealth elementary schools will be randomized into either the treatment or control interventions. The purpose of the FBC sessions is to change children's food environment. Specifically, we intend to increase the amount of fruit and vegetables, and decrease the amount of high fat foods available to children in their homes. In addition, we will encourage parents to model healthy dietary practices for their children. Two intervention strategies, a video, "What's to Eat?" developed for this population and photographs of each family's food practices, taken by family members, will be used in the counseling sessions. The control intervention will consist of group sessions using a curriculum that adapts standard nutrition recommendations for traditional Mexican-American foods. Community health advisors will conduct both the FBC and control sessions. The primary outcome of the trial is children's BMI. The secondary outcome is household food supplies. We hypothesize that within a one year timeframe, children's whose mothers are exposed to the FBC will have lower BMI's compared to children whose mothers receive the active placebo control intervention. The mechanism through which we intend to change weight status is altering the type of foods available to children in their homes. Therefore, two household food inventories, one collected prior to and one after the family's payday will be used as secondary outcomes. In addition, mothers' reports of household food security level, food purchase motives, and family food interaction will be collected as covariates. Measurements will be collected within one month of completing the interventions and at six months and one year follow-up.
DESIGN NARRATIVE:
Family Based Counseling. Community health advisors visit mothers who are randomly assigned to the FBC sessions once a month, for six months, in their homes. During the first session, mothers watch the video, "What's to Eat?" with the CHA and discuss food related parenting issues. In the subsequent five sessions, photographs of the family's food habits, taken by mothers, are used as visual aids for the intervention sessions. In addition, at each session, the CHA provides mothers with a food sample related to their dietary change goal. Examples of the types of foods provided to families include fat free milk, cooking oil spray, fruits and vegetables or low fat yogurt.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 9 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria for the study are:
- •Ethnicity: Mother is of Mexican descent and identifies with the Mexican-American community.
- •Age: Child is between 6 and 9 years 11.9 months old.
- •Family lives in the San Jose area
- •Family does not plan to move out of the area within the next 12 months.
排除标准
- •for the study are:
- •Metabolic disease/syndrome associated with obesity.
- •Chronic gastro-intestinal disease
- •Chronic renal disease
- •Heart disease
- •Eating disorders
- •Aids/HIV infection
- •Use of steroids
- •Use of insulin injections
- •Use of oral antidiabetic agents
- •Use of thyroid hormones
- •Use of growth hormones
- •Other diseases or use of other medications that may impact growth based on Dr. Mendoza's assessment.
- •Family shares food with 2 other families with children under the age of 12.
研究组 & 干预措施
in home nutrition counseling
In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors
干预措施: In home nutrition counseling (Behavioral)
standard nutrition education curriculum
standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid
干预措施: standard nutrition education curriculum (Other)
结局指标
主要结局
Mean Change in Body Mass Index (BMI)
时间窗: 12 months
child's Body Mass Index
次要结局
未报告次要终点
