Diabetes in India Nutrition Guidelines Study (DINGS)

Study Overview
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Brief Summary
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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
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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)

Official Title
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Diabetes in India Nutrition Guidelines Study (DINGS)

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: MNT according to AND EBNPG for Type 2 DM
* Other: Usual Nutrition Care


Participation Criteria
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Eligibility Criteria
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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 Exclusion criteria: Small clientele of adult type 2 DM, Fewer than two years' active clinical practice experience post-professional degree, Unable to comply with the other inclusion criteria (see inclusion section above). Patient Participant Patients' Inclusion Criteria: Must be over 19 years of age Must have medical diagnosis for treatment of type 2 DM, Patient must agree to return for follow-up visits (or data collection visit) during the 12 months study period Not seen by RD for one year prior to being recruited to the study Patients' Exclusion Criteria: Currently being seen by RD for MNT Participated in nutritional consults with RD in past year Having insulin prescribed for DM treatment at time of recruitment Pregnant or lactating at time of study History of end stage renal disease or renal insufficiency; history of CVA, CAD or MI; COPD; CHF; untreated depression; severe psychiatric illness; cancer diagnosis in previous two years or on-going radiation or chemotherapy treatment Unplanned surgery requiring more than one overnight stay in the hospital within the previous week to initial visit The presence of cognitive or physical limitations that preclude making lifestyle or dietary changes as assessed by the RD during the initial interview Unable to return to office for data collection at 6 and 12 months and unable to commit to follow-up visits for EBNPG. Patient Dis-enrollment or Stop Point for Study Participation Patient will no longer be in the study after he/she reports the onset of: End stage renal disease or renal insufficiency; CVA, CAD or MI; COPD; Depression, severe psychiatric illness; Cancer diagnosis and treatment; CHF; Unplanned surgery requiring more than one overnight stay in the hospital within the previous week; Pregnant, Any onset of cognitive or physical limitations that preclude making lifestyle or dietary changes per RD assessment during study period, Other acute/chronic complications that could exacerbate the patient's diabetic condition or general well-being. Physician starts injectable insulin therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MNT according to AND EBNPG for Type 2 DM<br>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<br>* 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)<br>* Other names: Evidence Based Nutrition Practice;|
| Active Comparator: Usual Nutrition Care<br>Visits for usual nutrition therapy (diet and lifestyle changes) provided by dietitians over a 12 month period. | Other: Usual Nutrition Care<br>* Usual nutrition care in India<br>* Other names: Nutrition Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbAIc decrease |  | 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change |  | 6 month and 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Medical Nutrition Therapy, Diabetes Mellitus, Nutrition outcomes, Evidence Based Guidelines