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Family-Based Nutrition Intervention for Latino Children

Primary Purpose

Obesity, Heart Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
In home nutrition counseling
standard nutrition education curriculum
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

6 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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. The exclusion criteria for the study are: Metabolic disease/syndrome associated with obesity. Diabetes 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    in home nutrition counseling

    standard nutrition education curriculum

    Arm Description

    In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors

    standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid

    Outcomes

    Primary Outcome Measures

    Mean Change in Body Mass Index (BMI)
    child's Body Mass Index

    Secondary Outcome Measures

    Full Information

    First Posted
    September 21, 2005
    Last Updated
    April 8, 2021
    Sponsor
    Stanford University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00224887
    Brief Title
    Family-Based Nutrition Intervention for Latino Children
    Official Title
    Family-Based Nutrition Intervention for Latino Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2003 (undefined)
    Primary Completion Date
    July 2008 (Actual)
    Study Completion Date
    July 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Stanford University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Heart Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    307 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    in home nutrition counseling
    Arm Type
    Experimental
    Arm Description
    In-home family-based behavioral counseling using in-person and video interventions delivered by community health advisors
    Arm Title
    standard nutrition education curriculum
    Arm Type
    Active Comparator
    Arm Description
    standard nutrition education curriculum consisting of video and lesson plans based on USDA Food Guide pyramid
    Intervention Type
    Behavioral
    Intervention Name(s)
    In home nutrition counseling
    Intervention Description
    In home family-based behavioral counseling
    Intervention Type
    Other
    Intervention Name(s)
    standard nutrition education curriculum
    Intervention Description
    video and lesson plans based on USDA Food Guide Pyramid
    Primary Outcome Measure Information:
    Title
    Mean Change in Body Mass Index (BMI)
    Description
    child's Body Mass Index
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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. The exclusion criteria for the study are: Metabolic disease/syndrome associated with obesity. Diabetes 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No plan to share data

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    Family-Based Nutrition Intervention for Latino Children

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