An interventional study of MNT according to AND EBNPG for Type 2 DM and Usual Nutrition Care in Type 2 Diabetes Mellitus, sponsored by Academy of Nutrition and Dietetics. Completed at 14 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-22.
Sponsored by Academy of Nutrition and Dietetics · Not applicable, Interventional, and Treatment
A clinical trial to compare the patient outcomes from usual nutrition therapy by dietitians in India to patient outcomes from guideline-based Medical Nutrition Therapy (MNT).
A cluster randomized clinical trial to compare patient outcomes from two different nutrition interventions by dietitians in India for persons with Type 2 Diabetes Mellitus (usual care vs Medical Nutrition Therapy provided according to the Academy of Nutrition and Dietetics Evidence-Based Nutrition Practice Guidelines)
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 238 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Academy of Nutrition and Dietetics is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion and exclusion criteria for participant selection is listed both for the dietitians and patient participants.
Dietitian Participant
Inclusion Criteria:
Active practice (at least two years post-professional degree), with enough newly diagnosed type 2 DM patients or patients not seen by an RD for the previous year, to be able to recruit four to six of them into the study each week
Exclusion criteria:
Patient Participant
Patients' Inclusion Criteria:
Patients' Exclusion Criteria:
Patient Dis-enrollment or Stop Point for Study Participation
Patient will no longer be in the study after he/she reports the onset of:
Six or more Medical Nutrition Therapy visits(education and counseling on diet, self management, and lifestyle changes) provided over a 12 month period according to Academy of Nutrition and Dietetic Evidence Based Nutrition Practice Guidelines (EBPGN) (www.guidelines.gov)
Other: MNT according to AND EBNPG for Type 2 DM
Visits for usual nutrition therapy (diet and lifestyle changes) provided by dietitians over a 12 month period.
Other: Usual Nutrition Care
Six or more Medical Nutrition Therapy visits(education and counseling on diet, self management, and lifestyle changes) provided over a 12 month period according to Academy of Nutrition and Dietetic Evidence Based Nutrition Practice Guidelines (EBNPG)(www.guidelines.gov)
Also known as: Nutrition Counseling, Nutrition Care, Nutrition Therapy, Evidence Based Nutrition Practice
Usual nutrition care in India
Also known as: Nutrition Counselling, Nutrition Therapy
HbAIc decrease
Time frame: 6 months and 12 months
Weight change
Time frame: 6 month and 12 month
Lipid panel
Total Cholesterol, LDL Cholesterol, HDL Cholesterol and Triglycerides
Time frame: 6 month and 12 month
Blood pressure
Systolic and Diastolic change from baseline measure
Time frame: 6 months and 12 months
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Academy of Nutrition and Dietetics