Family-Based Nutrition Intervention for Latino Children
Condition: Obesity; Heart Diseases
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Group Based Nutrition Sessions Families assigned to the group sessions are invited to one
      group session a month for six months. Group sessions are held in the morning and the evening
      to accommodate mothers' schedules. The groups sessions are based on a standard
      Mexican-American nutrition curriculum. This curriculum consists of a video and five lesson
      plans based on the USDA Food Guide Pyramid that emphasize foods indigenous to the Mexican
      diet. In addition to lessons from the curriculum, nutrition games, based on popular game
      shows such as "Nutrition Jeopardy" and "Family Feud" are also played during the sessions.

      Primary Outcome Measure - Children's Weight Status Height & Weight: Standing height will be
      measured twice, to the nearest millimeter, using a portable direct reading stadiometer. If
      the two measures differ by more than 5 mm, a third measure will be obtained. Body weight will
      be measured twice, to the nearest 0.1 kg, using digital scales with subjects wearing light
      indoor clothing without shoes. If the two measures differ by more than 0.2 kg, a third
      measure will be obtained. The mean of the two measures, or the median of three measures, are
      used to calculate BMI.

      Secondary Outcome Variable Our intervention is designed to prevent obesity in children by
      changing their food environments. Therefore, the secondary outcome for this research is
      changes in the type of food available to children in their homes. Specifically, a,
      quantitative household food inventory that assess the actual amount of fruit, vegetables,
      high fat foods and total food energy is collected. Inventories are collected within three
      days of grocery shopping. Two trained research assistants conduct each inventory, which
      require approximately 15 to 60 minutes to complete. All foods except spices, hot sauces,
      baking powder, baking soda, coffee, tea and spoiled foods are collected in the inventories.
      The amounts listed on the label of packaged, canned, or frozen foods are recorded, and if
      opened, the proportion remaining in the package is recorded. The amount of meat or cheese is
      recorded in pounds based on the package label. The number of fresh fruits, vegetables and
      eggs are counted. Beverages are recorded in fluid ounces or gallons. Prepared foods on the
      stove or leftover in the refrigerator are estimated in cups.

      Mothers' Socio-environment Measurements Demographics: Demographic variables, including
      household composition, who in the household shares the same food supplies, and where mothers
      purchase or receive food supplies (including WIC or food donations) will be collected from
      the mothers. To examine the variability in household food supplies relative to pay day,
      mothers will also report when their family receives pay checks. Children's demographic
      variables will include gender, age, and grade level.

      Household Level of Food Security: Food security is defined as people's assured access to
      enough acceptable food, that is acquired in socially acceptable ways, for an active and
      healthy life. This construct will be measured using the 18 item U.S.D.A. Core Food Security
      Module (FSM). This instrument conceptualizes food security as consisting of four components:
      1) quantity of food, 2) quality of food, 3) food anxiety and 4) food acquisition in socially
      acceptable ways (166, 167). Households are categorized into four levels of food insecurity:
      1) food secure, 2) food insecure without hunger, 3) food insecure with moderate hunger and 4)
      food insecure with severe hunger (i.e., children's food intake is restricted).
    

Intervention name(s): In home nutrition counseling; standard nutrition education curriculum
Intervention type(s): Behavioral; Other
Intervention description(s): In home family-based behavioral counseling; video and lesson plans based on USDA Food Guide Pyramid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention