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

This study has been completed.
Sponsor:
Collaborators:
Indian Institute of Nutritional Sciences
Academy of Nutrition and Dietetics Foundation
Abbott Healthcare Private Limited (in India)
Information provided by (Responsible Party):
Academy of Nutrition and Dietetics
ClinicalTrials.gov Identifier:
NCT01703611
First received: October 6, 2012
Last updated: February 18, 2016
Last verified: February 2016
  Purpose
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).

Condition Intervention
Type 2 Diabetes Mellitus
Other: MNT according to AND EBNPG for Type 2 DM
Other: Usual Nutrition Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Diabetes in India Nutrition Guidelines Study (DINGS)

Resource links provided by NLM:


Further study details as provided by Academy of Nutrition and Dietetics:

Primary Outcome Measures:
  • HbAIc decrease [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight change [ Time Frame: 6 month and 12 month ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Lipid panel [ Time Frame: 6 month and 12 month ] [ Designated as safety issue: No ]
    Total Cholesterol, LDL Cholesterol, HDL Cholesterol and Triglycerides

  • Blood pressure [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    Systolic and Diastolic change from baseline measure


Enrollment: 238
Study Start Date: December 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Other: 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)
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.
Other: Usual Nutrition Care
Usual nutrition care in India
Other Names:
  • Nutrition Counselling
  • Nutrition Therapy

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)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703611

Locations
India
Nagajuna Hospital
Vijayawada, Andhra Pradesh, India, 520007
Barman Diabetes Specialties
Guwahati, Assam, India
Dia Care 1 & 2
Amadavad, Gujarat, India, 380015
Fortis Escorts Hospital
Faridabad, Haryana, India, 121007
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, 302015
Sundaram Medical Foundation
Chennai, Tamilnadu, India, 600040
PSG Hospitals
Coimbatore, Tamilnadu, India, 641004
Sanjay Gandhi Post Graduate Institute
Lucknow, India, 226014
Fortis Hospital
Uttar Pradesh, India
Sponsors and Collaborators
Academy of Nutrition and Dietetics
Indian Institute of Nutritional Sciences
Academy of Nutrition and Dietetics Foundation
Abbott Healthcare Private Limited (in India)
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
  More Information

Responsible Party: Academy of Nutrition and Dietetics
ClinicalTrials.gov Identifier: NCT01703611     History of Changes
Other Study ID Numbers: Academy-India-1  IINS-ANDF/2011/01 
Study First Received: October 6, 2012
Last Updated: February 18, 2016
Health Authority: India: Drugs Controller General of India

Keywords provided by Academy of Nutrition and Dietetics:
Nutrition
Medical Nutrition Therapy
Diabetes Mellitus
Nutrition outcomes
Evidence Based Guidelines

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2016