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CTRI Number  CTRI/2013/10/004049 [Registered on: 07/10/2013] Trial Registered Retrospectively
Last Modified On: 28/01/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Diet and lifestyle InterventionS through Anganwadi Workers and Accredited Social Health Activists (DISHA) 
Scientific Title of Study   Effectiveness of diet and lifestyle intervention through Information Education Communication (IEC) tools with Angan Wadi Centres (AWCs) as the centre of knowledge dissemination for hypertension (including hypercholesterolemia and diabetes) risk reduction – a cluster randomised controlled trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dorairaj Prabhakaran 
Designation  Executive Director 
Affiliation  Centre for Chronic Disease Control 
Address  Tower 4, Commercial Complex, C 9, Vasant Kunj, New Delhi.

South West
DELHI
110070
India 
Phone  011-43421900  
Fax  011-43421975  
Email  dprabhakaran@ccdcindia.org  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dorairaj Prabhakaran 
Designation  Executive Director 
Affiliation  Centre for Chronic Disease Control 
Address  Tower 4, Commercial Complex, C 9, Vasant Kunj, New Delhi.

South West
DELHI
110070
India 
Phone  011-43421900  
Fax  011-43421975  
Email  dprabhakaran@ccdcindia.org  
 
Details of Contact Person
Public Query
 
Name  Nidhi Sobti 
Designation  Research Fellow 
Affiliation  Centre for Chronic Disease Control 
Address  Tower 4, Commercial Complex, C 9, Vasant Kunj, New Delhi.

South West
DELHI
110070
India 
Phone  01143421954  
Fax  011-43421975  
Email  nidhi@ccdcindia.org  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Indian Council of Medical Research Ansari Nagar, New Delhi - 110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jyoti Sanghvi  Indore  Associate Professor, Department of Pediatrics, Ward No. 106, First Floor, Sri Aurobindo Institute of Medical Sciences Ujjain State Highway, Near MR 10 Crossing, Indore-453111 Madhya Pradesh
Dhar
MADHYA PRADESH 
09826010403
0731-4231010
jyotisanghvi@yahoo.com 
Dr Sulaiman Ladhani  Junagadh  Consulting Room. No. 10, Ground Floor, Prince Aly Khan Hospital, Behind Main Building, Nesbit Road, Mazgoan, Mumbai - 400010. Maharastra
Junagadh
GUJARAT 
09820336674
022-66139670
sladhani@gmail.com 
Dr Anil J Purty  Puducherry  Professor of Community Medicine Room No. 264, OPD Building, 1st Floor, Department of Community Medicine, Pondicherry Institute of Medical Sciences (A Unit of Madras Medical Mission) Kalapet, Puducherry-605014, India
Pondicherry
PONDICHERRY 
09442233460

anilpurty@hotmail.com 
Dr P C Negi   Shimla  Professor & Head, Department of Cardiology, Room No. 637, Block C, Floor 6, Indira Gandhi Medical College Circular Road Shimla- 171001 Himachal Pradesh Himachal Pradesh
Shimla
HIMACHAL PRADESH 
09418103709
01772800168
igmc.shimla.2013@gmail.com 
Dr Ashok Bhardwaj  Tanda  Professor & Head Department of Community Medicine, B.C.Roy Block, 4th Floor Dr. Rajendra Prasad Government Medical College Tanda-176001 Himachal Pradesh
Kangra
HIMACHAL PRADESH 
098162023093
0731-4231010
ashoknonu@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Dr Rajendra Prasad Government Medical College and Hospital, Institutional Ethics Committee  Approved 
Ethics Committee, Indira Gandhi Hospital, Shimla  Approved 
Pondicherry Institute of Medical Sciences  Approved 
Prince Aly Khan Hospital, Junagarh  Approved 
Sri Aurobindo Institute of Medical Sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NCD risk-factor assessment of community participants is conducted, followed by a health-promotion intervention in intervention clusters. Change in population level blood pressure will be assessed. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DISHA (Diet and lifestyle InterventionS for Hypertension risk-reduction through Anganwadi Workers and accredited social health activists) Intervention   This is a diet and lifestyle intervention delivered by Anganwadi Workers & ASHAs for 18 months at individual,group & mass level to reduce hypertension risk in their communities by using Information Education Communication (IEC)as tools for 1)Reducing salt & oil consumption 2)Increasing dietary fibre intake 3)Increasing physical activity 4)Reducing alcohol &tobacco consumption. In both treatment clusters standard regimen for control of diabetes, hypertension & dyslipidemia including counselling for life style modification will be followed as medically indicated .But intensity of intervention would differ in the two groups. In intervention clusters, intense IEC would be given for 18 months, whereas, in control clusters, usual IEC would be imparted. 
Comparator Agent  Usual IEC Intervention  Control Clusters will receive usual(common) IEC intervention 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Any individual, irrespective of gender, who is more than 18 years of age, and permanently resides in the household will be approached to participate in this study for cardiovascular risk-factor assessment. 
 
ExclusionCriteria 
Details  This study proposes to study adults in the community to assess cardiovascular risk-factor prevalence in the community, and excludes adults below the age of 18 years.
Additional exclusions are:
• Pregnant women
• Bed-ridden individuals
• Persons who are unable to comprehend the interview questionnaire
(Reasons for exclusion will be documented)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be difference
between the changes in population level blood pressure between intervention and control clusters.
 
18 months
 
 
Secondary Outcome  
Outcome  TimePoints 
-Operational feasibility of integrating NCD risk reduction in community health programs through existing community level healthcare volunteers such as ASHA or equivalent.

-Usefulness of trained healthcare workers to affect changes in dietary fat, fibre and salt, tobacco and alcohol consumption and increasing physical activity.

-Efficacy of the IEC intervention to evaluate changes in lipid levels and glycemia.
 
18 months 
 
Target Sample Size   Total Sample Size="18000"
Sample Size from India="18000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   10/11/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Brief Summary  

The primary goal of the  present study  is to assess the effectiveness of intense versus usual Information Education Communication (IEC) interventions on diet and lifestyle modifications delivered by existing community-level health-workers (Anganwadi workers or ASHAs or equivalent) on population level blood pressure;  the aim being assessment of   operational feasibility of integrating NCD risk reduction in community health programs through existing community level healthcare volunteers such as Anganwadi Workers or ASHAs (community health workers – CHWs).

This feasibility study specifically aims to assess the usefulness of trained CHWs to facilitate changes in dietary fat, fibre and salt, tobacco and alcohol consumption and increasing physical activity at the community level in the Indian rural and urban health systems setting. The efficacy of these interventions to evaluate clinical indicators namely changes in lipid levels and glycemia will also be assessed.

This study is a collaborative effort between Centre for Chronic Disease Control (CCDC, New Delhi) and 5 participating sites, namely Pondicherry Institute of Medical Science (Pondicherry), Dr. Rajendra Prasad Government Medical College (Tanda); Indira Gandhi Medical College (Shimla) and Aga Khan Health Services (Mumbai with study site in Junagadh).

 

 

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