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CompletedNCT01703611DINGSUpdated Feb 22, 2016

Diabetes in India Nutrition Guidelines Study (DINGS)

An interventional study of MNT according to AND EBNPG for Type 2 DM and Usual Nutrition Care in Type 2 Diabetes Mellitus, sponsored by Academy of Nutrition and Dietetics. Completed at 14 sites in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-22.

Sponsored by Academy of Nutrition and Dietetics · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
238
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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)

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Nutrition
  • Medical Nutrition Therapy
  • Diabetes Mellitus
  • Nutrition outcomes
  • Evidence Based Guidelines
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 238 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Academy of Nutrition and Dietetics is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion and exclusion criteria for participant selection is listed both for the dietitians and patient participants.

Dietitian Participant

Inclusion criteria

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
238 participants (actual)

Study arms

  • 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

  • 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

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)

    Also known as: Nutrition Counseling, Nutrition Care, Nutrition Therapy, Evidence Based Nutrition Practice

  • OtherUsual Nutrition Care

    Usual nutrition care in India

    Also known as: Nutrition Counselling, Nutrition Therapy

06

What researchers measure

Primary outcomes

  1. HbAIc decrease

    Time frame: 6 months and 12 months

Secondary outcomes

  1. Weight change

    Time frame: 6 month and 12 month

Other outcomes

  1. Lipid panel

    Total Cholesterol, LDL Cholesterol, HDL Cholesterol and Triglycerides

    Time frame: 6 month and 12 month

  2. Blood pressure

    Systolic and Diastolic change from baseline measure

    Time frame: 6 months and 12 months

07

Study locations

14 sites
  • Nagajuna Hospital
    Vijayawada, Andhra Pradesh 520007, India
  • Barman Diabetes Specialties
    Guwahati, Assam, India
  • Dia Care 1 & 2
    Amadavad, Gujarat 380015, India
  • Fortis Escorts Hospital
    Faridabad, Haryana 121007, 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 302015, India
  • Sundaram Medical Foundation
    Chennai, Tamilnadu 600040, India
  • PSG Hospitals
    Coimbatore, Tamilnadu 641004, India
  • Sanjay Gandhi Post Graduate Institute
    Lucknow, 226014, India
  • Fortis Hospital
    Uttar Pradesh, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01703611
Lead sponsor
Academy of Nutrition and Dietetics
Collaborators
Indian Institute of Nutritional Sciences, Abbott Healthcare Private Limited (in India)
Responsible party
Sponsor
First posted
Oct 10, 2012
Start date
Dec 2012
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Feb 22, 2016

Study contacts

Esther F Myers, PhD
principal investigator · Academy of Nutrition and Dietetics
Varsha (none), PhD
principal investigator · Shri Shradda Hospital
Naomi Trostler, PhD
principal investigator · Hebrew University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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