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What is a Randomized Controlled Trial? from NCDHR

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Uploaded on Dec 29, 2010

The Deaf Weight Wise (DWW) Study Project, to be launched in summer 2011, is actually a "randomized controlled trial (RCT). RCT is a research study to find
out if an intervention (or a treatment) works well enough to prevent, diagnose or treat a health problem.

The main goal of DWW is to find out if the weight loss
intervention program is effective for Deaf adults. The DWW intervention includes: group or one-on-one sessions in ASL, behavioral modification and
motivation strategies, ASL videos, handouts, self-monitoring of eating and physical activities and more. There is a secondary goal to evaluate which
approach is more effective: group or one-on-one (videophone) interventions.

Any RCT requires an adequate number of eligible research volunteers
to participate in order to perform valid statistical tests. Health statistics and comparisons are scientifically required to confirm if an intervention or treatment under study really works. For the DWW Study Project, 216 Deaf adults, between 40 to 70 years of age, who live in the Rochester (NY) area and who are either overweight or obese will be enrolled. After the research volunteers meet the study's eligibility requirements (for example: are they healthy enough to do some exercises?), they will be randomly
assigned to one of 4 groups. Two groups will start the study right away (Phase I) for a 16-week session, either as a group or individually through a
videophone. The next two groups will
start the same study 6 months later (Phase II).

Research volunteers (participants) are assigned to one of the groups: they
will not have a choice on which group to join. For example, a participant may be assigned to do one-on-one intervention even though he/she preferred to
participate in a group session. It is like flipping a coin. Each participant will have a fair and equal chance of being either in the Phase I or Phase II groups. There will be no favoritism. This process of randomizing participants is a very
important research method to make sure the participants in both phases are
comparable. We do not want one group to be younger or healthier than the other group. Suppose the Phase I group had a greater number of healthy
participants than the Phase II group. Then, the results from the first 6 months
may show greater weight loss in the Phase I group than the Phase II group
because the healthier participants happen to be more physically active. This would have a misleading influence to the research question, "Did the
intervention itself really work?" Randomization prevents misleading influences and biases within a RCT study.

Results from groups 1 & 2 will be compared with groups 3 & 4 during the
first six months of the study. That way, researchers can compare the results between comparable groups to see whether the weight loss intervention is
successful. Randomized controlled trials, if followed properly, are scientific strategies to allow researchers to reliably tell if the intervention was effective.

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