Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
238 participants
INTERVENTIONAL
2012-12-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MNT 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 (EBPGN) (www.guidelines.gov)
MNT 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)
Usual Nutrition Care
Visits for usual nutrition therapy (diet and lifestyle changes) provided by dietitians over a 12 month period.
Usual Nutrition Care
Usual nutrition care in India
Interventions
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MNT 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)
Usual Nutrition Care
Usual nutrition care in India
Other Intervention Names
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Eligibility Criteria
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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
* 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
Patient Participant
* 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
Exclusion Criteria
* Small clientele of adult type 2 DM,
* Fewer than two years' active clinical practice experience post-professional degree,
* 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
18 Years
ALL
No
Sponsors
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Indian Institute of Nutritional Sciences
UNKNOWN
Abbott Healthcare Private Limited (in India)
OTHER
Academy of Nutrition and Dietetics
OTHER
Responsible Party
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Principal Investigators
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Esther F Myers, PhD
Role: PRINCIPAL_INVESTIGATOR
Academy of Nutrition and Dietetics
Varsha (none), PhD
Role: PRINCIPAL_INVESTIGATOR
Shri Shradda Hospital
Naomi Trostler, PhD
Role: PRINCIPAL_INVESTIGATOR
Hebrew University
Locations
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Nagajuna Hospital
Vijayawada, Andhra Pradesh, India
Barman Diabetes Specialties
Guwahati, Assam, India
Dia Care 1 & 2
Ahmedabad, Gujarat, India
Fortis Escorts Hospital
Faridabad, Haryana, India
Asian Institute of Medical Sciences
Faridabad, Haryana, India
Malabar Institute of Medical Sciences
Calicut, Kerala, India
Caritis Hospital
Kottayam, Kerala, India
BhaktiVedanta Hospital
Mumbai, Maharashtra, India
Star Hospitals
Hyderabad, Pradesh, India
Santokba Durlabji Memorial Hospital
Jaipur, Rajasthan, India
Sundaram Medical Foundation
Chennai, Tamil Nadu, India
PSG Hospitals
Coimbatore, Tamil Nadu, India
Sanjay Gandhi Post Graduate Institute
Lucknow, , India
Fortis Hospital
Uttar Pradesh, , India
Countries
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Other Identifiers
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IINS-ANDF/2011/01
Identifier Type: OTHER
Identifier Source: secondary_id
Academy-India-1
Identifier Type: -
Identifier Source: org_study_id
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