Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00224887 |
| Other study ID # |
320 |
| Secondary ID |
R01HL070218 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2003 |
| Est. completion date |
July 2008 |
Study information
| Verified date |
April 2021 |
| Source |
Stanford University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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).
