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PARTICIPANTS INFORMATION & INFORMED CONSENT

Dear Research Participants,

Greetings!

This is to provide you with information regarding the study entitled FRUITY-VEG: Alternative Diet for Blood Glucose Control. This study will be conducted by a group of level IV nursing student of WMSU, this city, together with their research adviser as co-researcher. The target study participants of this research are diagnosed diabetic. Herewith, are the following information; Why is the study being done? The FRUITY-VEG Diet intervention is being done to introduce a new alternative diet in controlling blood glucose level among diabetic patients. The diet consists of locally grown, readily available and accessible fruits and vegetables at the local market which makes a less costly meal and easy to prepare. What has been done previously? Based on our literature review, it shows that fiber in fruits and vegetables may help to mute blood sugar level. It is encouraged by the American Diabetes Association for people with diabetes to consume a variety of fiber containing foods. How will the present study be conducted? The procedure of the study is as follows; 1. Those diabetics who willingly signed for participation will be taken as subjects of the study. 2. Five days prior to the intervention of the FRUITY-VEG Diet post-prandial blood glucose test will be taken for five consecutive days among the study participants. Post-prandial would mean two hours after lunch, blood glucose test will be done. Five days prior to the intervention the study participants will take his/her regular or usual breakfast, midday snack, lunch, afternoon snacks, and dinner. The five-day FRUITY-VEG alternative diet intervention will follow. That would mean, on the next 5 days, the study participants will be served the FRUITY-VEG alternative lunch. Two hours after the FRUITY-VEG lunch, blood glucose test will be taken. During the five days intervention, the study participants, will take their regular or usual breakfast, snacks, FRUITY-VEG alternative lunch, usual afternoon

snack and dinner. Only the lunch is being controlled which will be prepared and serve by the researcher. 3. The pre-intervention and post intervention blood glucose test results will be compared and determine the significant difference. 4. For those study participants who are under medical regimen, their medication will continue as prescribed. What is the nature and extent of involvement of the participants in the research? The participant voluntarily submits to participate in the study. His/her blood glucose will be check 2 hours after lunch for 5 days before and after the FRUITY-VEG alternative lunch. The FRUITY-VEG alternative lunch will be served for free at no cost to the study participants. Risks and Inconveniences: Describe the risks and possible discomforts that may arise during the conduct of the study: 1. Very mild pain during extraction of blood in checking of the blood glucose level will be experienced by the study participant. A drop of blood sample will be taken from the finger tip only. 2. Participants adjustments to the FRUITY-VEG diet are being considered since it is a modification of the usual daily meal intake. The FRUITY-VEG lunch will be served in a form of shake (semi-liquid form). What benefits will be derived from the Study? It will benefit the participants in reducing their blood sugar level and they may become empowered and motivated to continue the FRUITY-VEG diet as one of their daily nutritional regimen to control their blood glucose level.

Compensation: Will there be reimbursement of travel expenses? No travel expenses will be incurred by the participants considering that the student researchers and adviser co-researcher will be the one to go to their respective residence or place of work. Will there be compensation of loss of income?

No expense from the study participants. All resources are being provided by the researchers.

Will there be meal expenses? The FRUITY-VEG diet will be served for free, hence; there will be no meal expense from the study participants.

Provisions for Psychological trauma, injury, or related illness: Will the participants be given free treatment in case of injury or illness incurred because of participating in the study? Any injury incurred during the intervention, the researchers will assume full responsibility. Contact Person: Who is the person knowledgeable about the research and rights of the participants? Carmen T. Ramos, RN, MAN, MPH, DNE, PPDM Adviser, Co-Researcher Khristy Rose Aquino. Contact #: 09354875845

Voluntariness of the Participation: Is there an assurance that the study participant may withdraw anytime without affecting treatment care due him/her for the injuries that will possibly be incurred during the conduct of the research? Participants may withdraw at any time without consequences of any kind or loss of benefit on their part, neither to the research work. Confidentiality: Is there a statement that describes the measure that will be taken to keep and ensure the confidentiality of the participants? Any information obtained with this study that is identified with the participants will be treated with strict confidence. Any disclosure of any part of this study will be done with full consent of the participants and concerned authority. Confidentiality will be

maintained by means of pseudonyms or by the use of initials in place of study participants identification when needed.

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