Diabetes in India Nutrition Guidelines Study (DINGS)

NCT01703611 | Completed DMC

• 2 other identifiers: Academy-India-1IINS-ANDF/2011/01
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 14

Brief 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).

Conditions

Type 2 Diabetes Mellitus

Keywords

Nutrition; Medical Nutrition Therapy; Diabetes Mellitus; Nutrition outcomes; Evidence Based Guidelines

Outcome Measures

Primary Outcomes (1)

• HbAIc decrease

  6 months and 12 months

Secondary Outcomes (1)

• Weight change

  6 month and 12 month

Other Outcomes (2)

• Lipid panel

  6 month and 12 month

• Blood pressure

  6 months and 12 months

Study Arms (2)

MNT according to AND EBNPG for Type 2 DM

EXPERIMENTAL

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

Usual Nutrition Care

ACTIVE COMPARATOR

Visits for usual nutrition therapy (diet and lifestyle changes) provided by dietitians over a 12 month period.

Other: Usual Nutrition Care

Interventions

MNT according to AND EBNPG for Type 2 DM OTHER

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

MNT according to AND EBNPG for Type 2 DM

Usual Nutrition Care OTHER

Usual nutrition care in India

Also known as: Nutrition Counselling, Nutrition Therapy

Usual Nutrition Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Dietitian Participant
• 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
• Small clientele of adult type 2 DM,
• Fewer than two years' active clinical practice experience post-professional degree,
• Patient Participant

Sponsors & Collaborators

• Academy of Nutrition and Dietetics: lead
• Indian Institute of Nutritional Sciences: collaborator
• Abbott Healthcare Private Limited (in India): collaborator

Study Sites (14)

Nagajuna Hospital

Vijayawada, Andhra Pradesh, 520007, India

Location

Barman Diabetes Specialties

Guwahati, Assam, India

Location

Dia Care 1 & 2

Ahmedabad, Gujarat, 380015, India

Location

Fortis Escorts Hospital

Faridabad, Haryana, 121007, India

Location

Asian Institute of Medical Sciences

Faridabad, Haryana, India

Location

Malabar Institute of Medical Sciences

Calicut, Kerala, India

Location

Caritis Hospital

Kottayam, Kerala, India

Location

BhaktiVedanta Hospital

Mumbai, Maharashtra, India

Location

Star Hospitals

Hyderabad, Pradesh, India

Location

Santokba Durlabji Memorial Hospital

Jaipur, Rajasthan, 302015, India

Location

Sundaram Medical Foundation

Chennai, Tamil Nadu, 600040, India

Location

PSG Hospitals

Coimbatore, Tamil Nadu, 641004, India

Location

Sanjay Gandhi Post Graduate Institute

Lucknow, 226014, India

Location

Fortis Hospital

Uttar Pradesh, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Esther F Myers, PhD

  Academy of Nutrition and Dietetics

  PRINCIPAL INVESTIGATOR

• Varsha (none), PhD

  Shri Shradda Hospital

  PRINCIPAL INVESTIGATOR

• Naomi Trostler, PhD

  Hebrew University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2012
• First Posted: October 10, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 22, 2016

Record last verified: 2016-02

Locations

IN (14)