Clinical Study, Outline Example

Significance of the problem

While health care professionals often recommend that their pregnant patients should take prenatal vitamins, some recommend those with DHA while others claim that it is not important. Docosahexaenoic acid (DHA) is essential for the growth and functional development of the brain in infants, but it is believed that the fetus is able to retrieve this nutrient from its mother. An excess of DHA that is consumed in the form of pill may not enhance brain development and protect against mental illness later in life.

Specific aim of the study

To determine whether vitamin consumption with DHA will prevent the development of measurable mental illness in childhood.

Research question(s)

Are pregnant mothers who consume vitamins with DHA more or less likely to give birth to children who have attention deficit hyperactivity disorder (ADHD)?

Hypothesis

DHA consumption will act as a protective factor against ADHD.

Theoretical/conceptual framework

It is believed that DHA supports fetal brain development. However, its effects aren’t well known. Despite this, researchers believe that children who lacked exposure to this enzyme during development are more likely to develop ADHD during their early childhood. Furthermore, these individuals are more likely to develop Alzheimer’s later in life. While many doctors recommend vitamins with DHA to pregnant women, few studies have been conducted to determine whether this treatment allows these harmful effects to be avoided.

Study design

A longitudinal study will be performed that compares the mental health outcome of children whose mothers consumed DHA during pregnancy to those who did not. The subjects will be identified before conception to ensure the control group is exposed to no DHA while the experimental group is exposed to the proper amount. The children will be followed for the first 16 years after their birth to determine whether they develop ADHD.

Subjects

Sampling design 

1000 patients will be randomly selected for study from gynecologist’s offices in the state.

Sampling criteria

Inclusion and exclusion criteria

These women must not currently be pregnant and have no family history of mental health disorders and be considered in relatively good health. Women between the ages of 18 to 35 will be considered.

Variables

Independent variable(s)

The independent variable will be exposure to DHA.

Dependent variable(s)

The dependent variable will be development of ADHD

Confounding or extraneous variable(s)

A genetic analysis of the newborn will be performed to determine whether they are genetically predisposed for ADHD.

Statistical issues

Sample size

1000 pregnant mothers. Twins will be included on the study based on selection of their mothers.

Approach analyses.

The statistical procedures that will be included in this experiment include a student’s t-test, calculation of relative risk and a chi-square test. If the distribution of these variables do not follow the normal distribution, the non-parametric tests will be used.