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CTRI Number  CTRI/2013/01/003282 [Registered on: 02/01/2013] Trial Registered Retrospectively
Last Modified On: 18/02/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes
Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   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. 
Scientific Title of Study   Diabetes in India- Nutrition Guidelines Study (DINGS)  
Trial Acronym  DINGS 
Secondary IDs if Any  
Secondary ID  Identifier 
IINS-ANDF/2011/01 dated 6 Dec 2011  Protocol Number 
NCT01703611  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varsha 
Designation  PhD 
Affiliation  Indian Insitute of Nutritional Sciences 
Address  Shri Shradda No 5 Third St, Dr Thirumurthy Nagar Nungambakkam Tamil Nadu
P Japee and IINS Communication Address CO PH Japee and Co Ankur Manor Number 271 Peeriyar EVY High Road, Kilpauk, Chennai
Chennai
TAMIL NADU
600 034
India 
Phone  4428228223  
Fax    
Email  drvarsha@eth.net  
 
Details of Contact Person
Scientific Query  
Name  Varsha 
Designation  PhD 
Affiliation  Indian Insitute of Nutritional Sciences 
Address  Shri Shradda No 5 Third St, Dr Thirumurthy Nagar Nungambakkam Tamilnadu
P Japee and IINS Communication Address C/o PH Japee and Co Ankur Manor Number 271 Periyar EVR High Road Kilpauk Chennai
Chennai
TAMIL NADU
600 034
India 
Phone  442-822-8223  
Fax    
Email  drvarsha@eth.net  
 
Details of Contact Person
Public Query  
Name  Dr Varsha 
Designation  India Principal Investigator 
Affiliation  Indian Institute of Nutritional Sciences 
Address  Shri Shradda Number5 Third St, Dr Thirumurthy Nagar Nungambakkam Tamilnadu
P Japee and IINS Communication Address C/o PK Japee and Co "Ankur Manor" Number 271 Periyar EVR High Road Kilpauk Chennai
Chennai
TAMIL NADU
600 034
India 
Phone  4428228223  
Fax    
Email  drvarsha@eth.net  
 
Source of Monetary or Material Support  
Abbott International 
 
Primary Sponsor  
Name  Academy of Nutrition and Dietetics Foundation 
Address  120 S RIverside Plaza, Suite 2000 Chicago, IL 60606-6995 
Type of Sponsor  Other [Professional Society Foundation] 
 
Details of Secondary Sponsor  
Name  Address 
Indian Institute of Nutritional Sciences  Shri Shradda #5 Third St, Dr Thirumurthy Nagar Nungambakkam Tamilnadu 600 034 India  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 22  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shilpa Thakur  Asian Institute of Medical Sciences  Dietitian Office, Asian Institute of Medical Sciences, Badkal Flyover Road Sector 21A Faridabad Haryana
Faridabad
HARYANA 		 1294253076
1294253000
shilpachadhathakur@gmail.com 
Arati Borah  Barman Diabetes Specialities  Dietitian Office, Barman Diabetes Specialities, Rukminigaon, Guwahati Assam
Golaghat
ASSAM 		 03612234050

aratiborah@hotmail.com 
Anuradha Borah  Barman Diabetes Specialities  Dietitian Office, Barman Diabetes Specialities, Rukminigaon, Guwahati Assam
Goalpara
ASSAM 		 03612234050

anuradhagori@rediffmail.com 
Vaidehi Amogh Nawathe  BhaktiVedanta Hospital Srishti sector-1  Dietitian Office, BhaktiVedanta Hospital Srishti sector-1, BhaktiVedanta Swami Marg, Mira Road Mumbai Maharashtra
Mumbai (Suburban)
MAHARASHTRA 		 02230052487

vaidehi@bhaktivedantahospital.com 
Swarna Vyas  Bhopal Memorial Hospital and Research Center  Dietitian Office, Bhopal Memorial Hospital and Research Center, C 76 Karond Rd, Bhopal 462038 Madhya Pradesh
Bhopal
MADHYA PRADESH 		 7553091333
7553091333
codc.help@gmail.com 
Remya Paul Mukkathu   Caritas Hospital  Dietitians Office, Caritas Hospital, Thellakom PO Kottayam, Kerala
Kottayam
KERALA 		 4812790025
4812790163
rjpdiet2011@gmail.com 
Smita Shah  Diabetes Care 1 and 2  Dietitian office, Dia Care 1 and 2 Gandhi Park, Near Nehru Nagar Ambuwadi Amdavad 380015 Gujarat
Ahmadabad
GUJARAT 		 792630410
7926302104
smitashah22@gmail.com 
Kiran Dalal  Fortis Escorts Hospital  Dietitian Office, Fortis Escorts Hospital, Neelam Bata Road, Faridabad 121007 Haryana
Faridabad
HARYANA 		 1292466184

kirandalal71@rediffmail.com 
Namita Nadar  Fortis Hospital  Dietitian Office, Fortis Hospital, B 22 Sec 62 Noida 201301 Uttar Pradesh
Sant Ravidas Nagar
UTTAR PRADESH 		 9811639717

namita.nadar@fortishealthcare.com 
Sanjay Mishra  Kalinga Hospital  Dietitian Office Kalinga Hospital, Chandrasekharpur Bhubaneshwar 751023 Orrisa
Jagatsinghapur
ORISSA 		 6742300570
6742300711
skmishra1973@rediffmail.com 
Ms Sherin Varghese  Malabar Institute of Medical Sciences  Dietitians office, Malabar Institute of Medical Sciences, Mini Bye Pass Road, Govindapuram PO, Calicut, Kerala
Kottayam
KERALA 		 4953091305
4952741329
dietitiansherin@gmail.com 
Sanghamitra Chakravarti  Medica Superspecialty Hospital  Dietitian Office, Medica Superspecialty Hospital, 127, Mukundapur, Em Bypass, Kolkatta 700 099 West Bengal
Kolkata
WEST BENGAL 		 0336552000

sanghamitra70@gmail.com 
Yamini Atri  Metro Heart Institute with Multispeciality  Dietitian Office, Metro Heart Institute with Multispeciality, Sector 16 A, Faridabad 121001
Faridabad
HARYANA 		 01294277777

yamini.attri@gmail.com 
Hema Devi Doddapaneni  Nagajuna Hospital  Dietitian Office, Nagajuna Hospital, Kanuru Vijayawada 520007 Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH 		 2554702-04

doddopaneni_h@yahoo.ca 
Sunitha Malhotra  PGIMER  Dietitians Office, PGIMER Number 3411,sector 37-D, Chandigarh, Punjab
Gurdaspur
PUNJAB 		 172275604

sunita_malhotra01@yahoo.co.in 
Kavita V  PSG Hospitals   Dietary Department, PSG Hospitals, Peelamedu, Coimbatore, 641004, Tamilnadu
Coimbatore
TAMIL NADU 		 4224345611
4222504400
kavithadietitian@gmail.com 
Charu Dua  Pushpanjali Crosslay Hospital  Dietitian Office, Pushpanjali Crosslay Hospital W3, Sector 1 Vaishali, NCR, Uttar Pradesh – 2012012
Sant Ravidas Nagar
UTTAR PRADESH 		 1204183188

charu_dietician@rediffmail.com 
Medhavi Gautam  Santokba Durlabji Memorial Hospital  Dietitian Office, Santokba Durlabji Memorial Hospital Bhavani Singh Marg Jaipur Rajasthan 302015
Jaipur
RAJASTHAN 		 01412566251

medhavigautam@yahoo.com 
Ms Rekha Vamsie Mohan  SP Hospital  Dietitian office, SP Hospital, 11 East Vellalar Street Adambakkam, Chennai, 600088 Tamilnadu
Chennai
TAMIL NADU 		 4422454595
4422456528
r_vamsie@yahoo.co.in 
Dr Hema Malini   Sri Ramachandra University  Department of Clinical Nutrition, Sri Ramachandra University, Porur, Chennai, 600116 Tamilnadu, India
Chennai
TAMIL NADU 		 4424767008

hemajanaradh@rediffmail.com 
Padma Pinnamaneni  Star Hospitals Road   Dietitian Office Star Hospitals Road # 10 Banjara Hills Hyderabad Andhra Pradesh
Hyderabad
ANDHRA PRADESH 		 44777777
23356788
padma.pinnamaneni@gmail.com 
Bamini Murgesh  Sundaram Medical Foundation,   Dietitian Office, Sundaram Medical Foundation, 4th Avenue, Shanthi Colony, Anna Nagar West, Chennai 600040
Chennai
TAMIL NADU 		 4426144163
4426284257
bamini_m@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 23  
Name of Committee  Approval Status 
ABMH Ethics Committee/Pune/G Dharmati  Approved 
Alert Ethics Committee/Thane for Barman Diabetes Specialties Pvt Ltd/Guwahti/Arati B and Anuradha B  Approved 
Alert Ethics Committee/Thane for Bhakti Vedanta Hospital/Mumbai/V Nawathe  Approved 
Alert Ethics Committee/Thane for Bhopal Memorial Hospital and Research Cennter/Bhopal/S Vyas  Approved 
Alert Ethics Committee/Thane for Metro Heart Institute with Multispecialty Hospital/Fardabad/Y Atri  Approved 
Alert Ethics Committee/Thane for Overall-Study/Chennai/Dr Varsha  Approved 
Alert Ethics Committee/Thane for SP Hospital/Chennai/R Vamsie  Approved 
Asian Instite of Medicine Ethics Committee/Faridabad/T Shilpa  Approved 
Caritas Hospital Ethics Committee/Kerala/R Mukkathu  Approved 
Clinical Research Ethics Committee - Medica Superspecialty Hospital/Kolkatta/S Chakravarti  Approved 
Dia Care Research Ethics Committee/Amdavad/S Shah  Approved 
Fortis Escorts Hospital and Research Center Independent Ethics Committee/Faridabad/K Dalal  Approved 
Institutional Ethical Committee of Pushpanjali Crosslay Hospital/Ghaziabad/C Dau  Approved 
Institutional Ethics Committee, Malabar Institute of Medical Sciences LTD./Calicut/S Varghese  Approved 
Institutional Review Board, Fortis Hospital Noida/Noida/N Nadar  Approved 
Kalinga Hospital Ethics Committee/Bhubaneshwar/S Mishra  Not Applicable 
Nagajuna Hospital Ethics Committee/Vijayawada/H D Doddapaneni  Approved 
Postgraduate Institute of Medical Education and Research, Chandigarh Ethics Review Committee/Chandrigarh/S Malhotra  Approved 
PSG Institute of Medical Sciences and Research Institutional Human Ethics Committee/Combatore/Dr Varsha/Kavita V  Approved 
Santhokba Durlabji Memorial Hosptial Ethics Committee/Jaipur/M Gautham  Approved 
Sri Ramachandra University Ethics Committee/Chennai/H Malina  Not Applicable 
Star Hospitals Institutional Ethics Committee/Hyderabad/P Pinnamaneni  Approved 
Sundaram Medical Foundation Institutional Review Board/Chennai/Bamini M  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 Diabetes Mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nutrition care provided according to Academy of Nutition and Dietetics Evidence-Based Nutrition Practice Guidelines  Nutrition Counseling is provided by dietitians with number of visits and suggested topics as outlined in EBPNG available at www.guidelines.gov. The dietitian determines the optimal frequency and duration of nutrition counseling, however the starting point is an initial series of 1-4 visits that are 45-90 minutes long within the three to six months of diagnosis or first referral. After the initial series, the dietitian determines the frequency and timing of follow-up series of visits that are usually 45-90 minutes in duration. There is a least one annual follow-up appointment of 45-90 minutes duration. Nutrition care according to the EBNPG includs nutrition assessment, nutrition diagnosis, nutrition intervention and nutrition monitoring and evaluation. Two recommendations address frequency and length of apointments. Three recommendations address what should be icluded in the nutrition assessment. Fourteen recommendations guide the nutrition intervention and two recommendations guide the activities of nutrition monitoring and evaluation. NOTE: This trial does not include testing medicaiton or equipment, however since self monitoring of blood glucose is central to the intervention, participants with diabetes are provided glucometers and strips as part of the intervention group 
Comparator Agent  Usual Nutrition Care  Nutrition counselling by dietitian is provided as is customary care in India. Usual care usually includes information on dietary planning. NOTE: This trial does not focus on medication or equipment. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Must be over 19 years of age
Must have medical diagnosis for treatment of type 2 Diabetes Mellitus,
Patient must agree to return for follow-up visits (or data collection visit) during the 12 months study period
Not seen by dietitian for one year prior to being recruited to the study
 
 
ExclusionCriteria 
Details  Currently being seen by dietitian for medical nutrition counselling
Participated in nutritional consults with dietitian in past year
Having insulin prescribed for Diabetes Mellitus treatment at time of recruitment
Pregnant or lactating at time of study
History of end stage renal disease or renal insufficiency; history of Cardiovascular accident, Coronary artery disease or Myocardial infarction; Chronic obstructive pulmonary disease; Congestive heart failure; 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 registered dietitian 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 as per evidence based nutrition practice guidelines and dietitians recommendations.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Hemoglobin A1C decrease  Baseline, 6 months, 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Medications:
Reduction in Diabetes relatedmedications treating hypoglycemia,
Change in dosages of medications to treat high blood pressure and lipids.
 		 6 month and 12 month 
Weight change   6 month and 12 month 
Lipid Panel  6 Month and 12 month 
Self Monitoring Data  6 month and 12 month 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

 This study will test the use of the Type 2 Diabetes Mellitus (DM) Evidence Based Nutrition Pratice Guideline (EBNPG) as a tool for dietitians to use with diabetic clients who do not yet have chronic complications and no evidence of organ damage. In addition to comparing the results of care provided using the EBNPG’s to a control group, we will evaluate the magnitude of the differences in current dietitian practice in India from those promoted by EBNPGs.  The evaluation will also determine what cultural adaptations to the guides will be necessary while still maintaining the integrity of the intent of the EBNPGs.

 

This small randomized controlled trial will explore the impact of implementing the Academy of Nutrition and Dietetics (Academy) EBNPGs in India on patient outcome and dietetics practice.  

 

 

STUDY AIMS

Primary Aim 

To determine the effect of the dietitian intervention using the type 2 DM EBNPG compared to usual care on client with diabetes health outcomes.

  1. Compare the change from baseline in nutrition-related health outcomes from clients provided care by dietitians in India following the Academy EBNPG with clients provided “usual care” by dietitians in India at 6 months and 12 months
  2. Compare the proportion of clients who achieve expected outcomes from clients provided care by dietitian in India following the Academy EBNPG with clients provided “usual care” by dietitians in India

 

Secondary Aim 

To determine the usability of Academy’s Type 2 DM EBNPG for Adults and Companion Toolkit for the dietitian intervention by dietitians in India:

a.       Evaluate the effect of the dietitian training on dietitians’ knowledge and skills of study protocol procedures and the implementation of the EBNPG,  demonstrate fidelity of intervention, and determine the extent to which dietitians implement the EBNPG. 

b. Determine if the training provided is appropriate and adequate for the

     implementation of Academy EBNPGs

c. Determine what cultural adaptations are needed for implementation in India

 

 
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