Could the study described in Problem 6 be designed as a randomized clinical tria

Question

Could the study described in Problem 6 be designed as a randomized clinical trial? If so, briefly outline the study design: if not, describe the barriers. A study is planned to compare two weight-loss programs in patients who are obese. The first program is based on restricted caloric intake and the second is based on specific food combinations. The study will involve 20 participants and each participant will follow each program. The programs will be assigned in random order (i.e., some participants will first follow the restricted-calorie diet and then follow the food-combination diet, whereas others will first follow the food combination diet and then

Explanation / Answer

Answer

Since all participants are treated with both treatments, the weight gain, if any, can be total effect or the interaction effect of the two treatments. Hence, this cannot be treated as a randomized clinical trial.

A simple Completely Randomised Design with equal or unequal number of observations per treatment would be ideal.

Ensure participants are of the same obese level. Randomly divide these participants into two groups of equal size or even unequal sizes.

Subject one group to Treatment 1(restricted calorie intake) and the other group to Treatment 2 (Specific Food Combination)

Response variable will be weight reduction and analysis tool will be One-way ANOVA

DONE

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