Diabetes in India Nutrition Guidelines Study (DINGS) (DINGS)

February 18, 2016 updated by: Academy of Nutrition and Dietetics
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).

Study Overview

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)

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lucknow, India, 226014
        • Sanjay Gandhi Post Graduate Institute
      • Uttar Pradesh, India
        • Fortis Hospital
    • Andhra Pradesh
      • Vijayawada, Andhra Pradesh, India, 520007
        • Nagajuna Hospital
    • Assam
      • Guwahati, Assam, India
        • Barman Diabetes Specialties
    • Gujarat
      • Amadavad, Gujarat, India, 380015
        • Dia Care 1 & 2
    • Haryana
      • Faridabad, Haryana, India, 121007
        • Fortis Escorts Hospital
      • Faridabad, Haryana, India
        • Asian Institute of Medical Sciences
    • Kerala
      • Calicut, Kerala, India
        • Malabar Institute of Medical Sciences
      • Kottayam, Kerala, India
        • Caritis Hospital
    • Maharashtra
      • Mumbai, Maharashtra, India
        • BhaktiVedanta Hospital
    • Pradesh
      • Hyderabad, Pradesh, India
        • Star Hospitals
    • Rajasthan
      • Jaipur, Rajasthan, India, 302015
        • Santokba Durlabji Memorial Hospital
    • Tamilnadu
      • Chennai, Tamilnadu, India, 600040
        • Sundaram Medical Foundation
      • Coimbatore, Tamilnadu, India, 641004
        • PSG Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
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)
Other Names:
  • Nutrition Counseling
  • Nutrition Care
  • Nutrition Therapy
  • Evidence Based Nutrition Practice
Active Comparator: Usual Nutrition Care
Visits for usual nutrition therapy (diet and lifestyle changes) provided by dietitians over a 12 month period.
Usual nutrition care in India
Other Names:
  • Nutrition Therapy
  • Nutrition Counselling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbAIc decrease
Time Frame: 6 months and 12 months
6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight change
Time Frame: 6 month and 12 month
6 month and 12 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid panel
Time Frame: 6 month and 12 month
Total Cholesterol, LDL Cholesterol, HDL Cholesterol and Triglycerides
6 month and 12 month
Blood pressure
Time Frame: 6 months and 12 months
Systolic and Diastolic change from baseline measure
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Esther F Myers, PhD, Academy of Nutrition and Dietetics
  • Principal Investigator: Varsha (none), PhD, Shri Shradda Hospital
  • Principal Investigator: Naomi Trostler, PhD, Hebrew University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 6, 2012

First Submitted That Met QC Criteria

October 6, 2012

First Posted (Estimate)

October 10, 2012

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Academy-India-1
  • IINS-ANDF/2011/01 (Other Identifier: India Clinical Trial Registry)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on MNT according to AND EBNPG for Type 2 DM

3
Subscribe