| CTRI Number |
CTRI/2013/10/004049 [Registered on: 07/10/2013] Trial Registered Retrospectively |
| Last Modified On: |
22/11/2019 |
| 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 |
| Trial Acronym |
DISHA Study |
|
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
|
|
|
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
|
|
|
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)= "25128"
Final Enrollment numbers achieved (India)="25128" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/11/2012 |
| Date of Study Completion (India) |
31/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Jeemon P, Narayanan G, Kondal D, Kahol K, Bharadwaj A, Purty A, Negi P, Ladhani S, Sanghvi J, Singh K, Kapoor D, Sobti N, Lall D, Manimunda S, Dwivedi S, Toteja G, Prabhakaran D; DISHA Study Investigators. Task shifting of frontline community health workers for cardiovascular risk reduction: design and rationale of a cluster randomised controlled trial (DISHA study) in India. BMC Public Health. 2016 Mar 15;16:264. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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).
.
|