Type 2 Diabetes Mellitus
Conditions
Keywords
Nutrition, Medical Nutrition Therapy, Diabetes Mellitus, Nutrition outcomes, Evidence Based Guidelines
Brief summary
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).
Detailed description
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)
Interventions
OTHERMNT according to AND EBNPG for Type 2 DM
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)
OTHERUsual Nutrition Care
Usual nutrition care in India
Sponsors
Indian Institute of Nutritional Sciences
Abbott Healthcare Private Limited (in India)
Academy of Nutrition and Dietetics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion and
Exclusion criteria
for participant selection is listed both for the dietitians and patient participants. Dietitian Participant Inclusion Criteria: * RD and Indian ICC CDE RD * 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 * Work in an Diabetes centers and hospital diabetes outpatient or private practice with diabetologist to provide medical oversight for study * Have written approval from immediate supervisor and diabetologist indicating that MNT visits can be provided without cost to research study in accordance with ADA EBNPG and data collection can be accommodated. * Have computer and internet access. Minimum requirements are Microsoft Internet Explorer 8.0 with 1024 x 768 screen resolution in 256 colors. The browser must be enabled for Java, JavaScript and cookies * Have stable internet connection (no prolonged periods without or frequent disruptions in internet service * Have land phone line and faxing capabilities * Able to provide data documentation electronically or in a paper format * Obtain approval from their facility's Independent Ethics Committee (equivalent to US Institutional Review Board) for participation in the study (if required by the institution) * Able to adjust the institution's habitual counseling session schedule and duration as required by the study protocol * Commit to attendance during the full course of face to face training for three days (including part of a weekend), to be held at Chennai, India, and participate in the Webinars and conference calls
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbAIc decrease | 6 months and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Weight change | 6 month and 12 month |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lipid panel | 6 month and 12 month | Total Cholesterol, LDL Cholesterol, HDL Cholesterol and Triglycerides |
| Blood pressure | 6 months and 12 months | Systolic and Diastolic change from baseline measure |
Countries
India
Outcome results
None listed