Research Design ( 1,2,3,4)

Meaning

A research design is a logical and systematic plan prepared for directing a research
study.

It specifies the objectives of the study, the methodology and techniques to be

adopted for achieving the objectives.

It “constitutes the blueprint for the collection, measurement and analysis of data”.

“It is the plan, structure and strategy of investigation conceived to obtain answers
to research questions.

The plan is the overall scheme or program of research”.

“A research design is the program that guides the investigator in the process of
collecting analyzing and interpreting observations”. It provides a systematic plan
of procedure for the researcher to follow

Features of A Good Research Design

[Link] is a plan that specifies the objectives of the study and the hypotheses to be
tested.

[Link] is an outline that specifies the sources and types of information relevant to the
research questions.

[Link] is a blueprint specifying the methods to be adopted for gathering and analyzing
the data.

[Link] is a scheme defining the domain in general and whether the obtained
information can be generalized to a larger population.

Factors Affecting Research Design

A research design is commonly affected by the following factors.

1. The degree of formulation of the problem.

 2. The topical scope- breadth and depth – of the study.

3. The research environment

4. The time dimension

5. The mode of data collection

6. The manipulation of variables under study

7. The nature of relationship among variables. After making decisions on the

above questions, a formal research plan is drafted, incorporating those
decisions.

The format may vary depending on the purpose for which the study is undertaken.

Evaluation of Research Design (need of research design)

A research design needs great care.

A researcher should decide what research design would be more appropriate for
the study.

There can be several research designs, each suitable for a different research study.

It may be difficult to state what constitutes an appropriate research design.

However the following aspects may be taken into consideration at the time of
deciding about the research design.

1. Minimum of error: The design in experimentation as well as personal bias

should be minimized to maximize the accuracy and reliability of results.

2. Yield Maximum Information: The design must be capable of yielding

maximum information at minimum cost, effort and time.

3. Flexibility: The research design should be flexible to permit consideration of a

large number of different aspects or phenomena etc. Much depends upon the nature
of the problem to be studied and the object of inquiry.

A design suitable for one research study may or may not be useful for another.
While deciding the research design, therefore, the nature of universe, objectives of
the study, sampling frame, desired standard of accuracy, etc. should be considered.
 Further, while considering alternative research designs both the strengths and
limitations should be examined. Comments may be invited from experts and a
design appropriate in the given condition should be selected.
Research Design in the field of nutrition

1. Descriptive studies – Correlation studies, Case studies, Cross-sectional surveys.

2. Analytical studies – Observational, Case control, Coherent studies -Prospective and

Retrospective

3. Experimental studies – Clinical/ Intervention trials including Randomized controlled trials.

Nutrition research employs various methods, including dietary assessment, observational studies
(cohort and cross-sectional), experimental designs, nutritional epidemiology, and qualitative
approaches, to understand the relationship between food, nutrients, and human health.

1. Descriptive studies

What is a Descriptive Study?

 Purpose: To describe the characteristics of a population, situation, or phenomenon.

  Focus: Answers questions about "what," "where," "when," and "how," but not "why".

 Data Collection: Involves observing and collecting data without manipulating the
environment or variables.

 Examples: Surveys, case studies, observational studies, and cross-sectional studies.

Types of Descriptive Studies in Nutrition Research:

 Surveys: Using questionnaires or interviews to collect data from a large group of people.

 Observational Studies: Observing and recording behaviors or characteristics without

intervention.

 Case Studies: In-depth examination of a specific individual or group.

 Cross-sectional Studies: Examining a population at a specific point in time.

 Longitudinal Studies: Following a group over a period to observe changes.

Benefits of Descriptive Studies:

 Provides a baseline understanding: Helps researchers understand the current state of a

population or phenomenon.

 Identifies patterns and trends: Can reveal relationships between variables.

 Useful for planning interventions: Information gathered can inform the development of
public health interventions.

 Estimates prevalence or incidence of disease: Helps assess the burden of disease in a

population.

Limitations of Descriptive Studies:

 Cannot establish cause-and-effect relationships: Descriptive studies cannot determine

if one variable causes another.

 May be time-consuming and resource-intensive: Collecting data from a large sample

can be challenging.

 Susceptible to bias: Researchers need to be aware of potential biases in data collection

and analysis.
2. Analytical studies:

Observational Studies

Observational studies in human nutrition collect information on people’s dietary patterns or

nutrient intake and look for associations with health outcomes. Observational studies do not give
participants a treatment or intervention; instead, they look at what they’re already doing and see
how it relates to their health. These types of study designs can only
identify correlations (relationships) between nutrition and health; they can’t show that one
factor causes another. (For that, we need intervention studies, which we’ll discuss in a moment.)
Observational studies that describe factors correlated with human health are also
called epidemiological studies.1

One example of a nutrition hypothesis that has been investigated using observational studies is
that eating a Mediterranean diet reduces the risk of developing cardiovascular disease. (A
Mediterranean diet focuses on whole grains, fruits and vegetables, beans and other legumes,
nuts, olive oil, herbs, and spices. It includes small amounts of animal protein (mostly fish), dairy,
and red wine.2) There are three main types of observational studies, all of which could be used to
test hypotheses about the Mediterranean diet:

 Cohort studies follow a group of people (a cohort) over time, measuring factors such as
diet and health outcomes. A cohort study of the Mediterranean diet would ask a group of
people to describe their diet, and then researchers would track them over time to see if
those eating a Mediterranean diet had a lower incidence of cardiovascular disease.

 Case-control studies compare a group of cases and controls, looking for differences
between the two groups that might explain their different health outcomes. For example,
researchers might compare a group of people with cardiovascular disease with a group of
healthy controls to see whether there were more controls or cases that followed a
Mediterranean diet.

 Cross-sectional studies collect information about a population of people at one point in

time. For example, a cross-sectional study might compare the dietary patterns of people
from different countries to see if diet correlates with the prevalence of cardiovascular
disease in the different countries.

Prospective cohort studies, which enroll a cohort and follow them into the future, are usually
considered the strongest type of observational study design. Retrospective studies look at what
happened in the past, and they’re considered weaker because they rely on people’s memory of
what they ate or how they felt in the past. There are several well-known examples
of prospective cohort studies that have described important correlations between diet and
disease:
  Framingham Heart Study: Beginning in 1948, this study has followed the residents of
Framingham, Massachusetts to identify risk factors for heart disease.

 Health Professionals Follow-Up Study: This study started in 1986 and enrolled 51,529
male health professionals (dentists, pharmacists, optometrists, osteopathic physicians,
podiatrists, and veterinarians), who complete diet questionnaires every 2 years.

 Nurses Health Studies: Beginning in 1976, these studies have enrolled three large
cohorts of nurses with a total of 280,000 participants. Participants have completed
detailed questionnaires about diet, other lifestyle factors (smoking and exercise, for
example), and health outcomes.

Observational studies have the advantage of allowing researchers to study large groups of people
in the real world, looking at the frequency and pattern of health outcomes and identifying factors
that correlate with them. But even very large observational studies may not apply to the
population as a whole. For example, the Health Professionals Follow-Up Study and the Nurses
Health Studies include people with above-average knowledge of health. In many ways, this
makes them ideal study subjects, because they may be more motivated to be part of the study and
to fill out detailed questionnaires for years. However, the findings of these studies may not apply
to people with less baseline knowledge of health.

We’ve already mentioned another important limitation of observational studies—that they can
only determine correlation, not causation. A prospective cohort study that finds that people
eating a Mediterranean diet have a lower incidence of heart disease can only show that the
Mediterranean diet is correlated with lowered risk of heart disease. It can’t show that the
Mediterranean diet directly prevents heart disease. Why? There are a huge number of factors that
determine health outcomes such as heart disease, and other factors might explain a correlation
found in an observational study. For example, people who eat a Mediterranean diet might also be
the same kind of people who exercise more, sleep more, have higher income (fish and nuts can
be expensive!), or be less stressed. These are called confounding factors; they’re factors that can
affect the outcome in question (i.e., heart disease) and also vary with the factor being studied
(i.e., Mediterranean diet).

3. Intervention Studies/ Experimental studies or Clinical trials

Intervention studies, also sometimes called experimental studies or clinical trials, include
some type of treatment or change imposed by the researcher. Examples of interventions in
nutrition research include asking participants to change their diet, take a supplement, or change
the time of day that they eat. Unlike observational studies, intervention studies can provide
evidence of cause and effect, so they are higher in the hierarchy of evidence pyramid.

The gold standard for intervention studies is the randomized controlled trial (RCT). In an RCT,
study subjects are recruited to participate in the study. They are then randomly assigned into
one of at least two groups, one of which is a control group (this is what makes the
study controlled). In an RCT to study the effects of the Mediterranean diet on cardiovascular
disease development, researchers might ask the control group to follow a low-fat diet (typically
recommended for heart disease prevention) and the intervention group to eat a Mediterrean diet.
The study would continue for a defined period of time (usually years to study an outcome like
heart disease), at which point the researchers would analyze their data to see if more people in
the control or Mediterranean diet had heart attacks or strokes. Because the treatment and control
groups were randomly assigned, they should be alike in every other way except for diet, so
differences in heart disease could be attributed to the diet. This eliminates the problem of
confounding factors found in observational research, and it’s why RCTs can provide evidence of
causation, not just correlation.

Imagine for a moment what would happen if the two groups weren’t randomly assigned. What if
the researchers let study participants choose which diet they’d like to adopt for the study? They
might, for whatever reason, end up with more overweight people who smoke and have high
blood pressure in the low-fat diet group, and more people who exercised regularly and had
already been eating lots of olive oil and nuts for years in the Mediterranean diet group. If they
found that the Mediterranean diet group had fewer heart attacks by the end of the study, they
would have no way of knowing if this was because of the diet or because of the underlying
differences in the groups. In other words, without randomization, their results would be
compromised by confounding factors, with many of the same limitations as observational
studies.

In an RCT of a supplement, the control group would receive a placebo—a “fake” treatment
that contains no active ingredients, such as a sugar pill. The use of a placebo is necessary in
medical research because of a phenomenon known as the placebo effect. The placebo
effect results in a beneficial effect because of a subject’s belief in the treatment, even though
there is no treatment actually being administered.

For example, imagine an athlete who consumes a sports drink and then runs 100 meters in 11.0
seconds. On a different day, under the exact same conditions, the athlete is given a Super Duper
Sports Drink and again runs 100 meters, this time in 10.5 seconds. But what the athlete didn’t
know was that the Super Duper Sports Drink was the same as the regular sports drink—it just
had a bit of food coloring added. There was nothing different between the drinks, but the
athlete believed that the Super Duper Sports Drink was going to help him run faster, so he did.
This improvement is due to the placebo effect. Ironically, a study similar to this example was
published in 2015, demonstrating the power of the placebo effect on athletic performance.3
Figure 2.4. An example of the placebo effect

Blinding is a technique to prevent bias in intervention studies. In a study without blinding, the
subject and the researchers both know what treatment the subject is receiving. This can lead to
bias if the subject or researcher have expectations about the treatment working, so these types of
trials are used less frequently. It’s best if a study is double-blind, meaning that neither the
researcher nor the subject know what treatment the subject is receiving. It’s relatively
simple to double-blind a study where subjects are receiving a placebo or treatment pill, because
they could be formulated to look and taste the same. In a single-blind study, either the researcher
or the subject knows what treatment they’re receiving, but not both. Studies of diets—such as the
Mediterranean diet example—often can’t be double-blinded because the study subjects know
whether or not they’re eating a lot of olive oil and nuts. However, the researchers who are
checking participants’ blood pressure or evaluating their medical records could be blinded to
their treatment group, reducing the chance of bias.

Limitations:

Like all studies, RCTs and other intervention studies do have some limitations.

 They can be difficult to carry on for long periods of time and require that participants
remain compliant with the intervention.
 They’re also costly and often have smaller sample sizes.
 Furthermore, it is unethical to study certain interventions. (An example of an unethical
intervention would be to advise one group of pregnant mothers to drink alcohol to
determine its effects on pregnancy outcomes, because we know that alcohol consumption
during pregnancy damages the developing fetus.)