A study is planned to compare two weight-loss programs in patients who are obese

Question

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 follow the restricted-calorie diet). The number of pounds lost will be compared between diets. Identify the type of study proposed and indicate its specific strengths and weaknesses.

Explanation / Answer

The study is a cross-over trial. The strengths include the ability to use each participant as his/her own control therefore there is no issue of comparability between groups in terms of other characteristics. One weakness is the possibility of carry-over effects, participants might get going with weight loss on the first diet and that momentum might carry over to the second. Another potential issue with cross-over trials is loss to follow-up. If a participants drops out of the study on his/her second diet, the information on the first diet in unusable. Thus, investigators must do everything possible to minimize drop out.

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