| CTRI Number |
CTRI/2020/04/024471 [Registered on: 03/04/2020] Trial Registered Prospectively |
| Last Modified On: |
23/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Behaviour modification intervention for reducing anaemia in pregnancy |
|
Scientific Title of Study
|
Enhanced, tailored antenatal care to reduce anaemia in pregnancy- the comprehensive anaemia programme and personalized therapies (CAPPT) project |
| Trial Acronym |
CAPPT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| not registered |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vatsla Dadhwal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 3073, Deptt of Obstetrics & Gynecology, AIIMS,Ansari Nagar
South
DELHI
110029
India |
| Phone |
09811015979 |
| Fax |
|
| Email |
vatslad@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vatsla Dadhwal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 3073
Deptt of Obstetrics & Gynecology
AIIMS
Ansari Nagar
South
DELHI
110029
India |
| Phone |
09811015979 |
| Fax |
|
| Email |
vatslad@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vatsla Dadhwal |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room 3073
Deptt of Obstetrics and Gynecology
Ansari Nagar
AIIMS
South
DELHI
110029
India |
| Phone |
09811015979 |
| Fax |
|
| Email |
vatslad@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology
Ministry of Science & Technology
Block 2, CGO Complex, Lodhi Road
New Delhi 110003 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar
New Delhi- 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vatsla Dadhwal |
CRHSP, AIIMS Ballabgarh |
Deptt of Community Medicine, CRHSP AIIMS, Mathura Road, National Highway 2, Ballabhgarh, Faridabad, Haryana 121004
Faridabad
HARYANA |
9811015979
vatslad@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Behaviour modification |
Home based nutritional counselling to improve dietary practices with respect to iron rich diet and tailored oral iron supplementation based on hemoglobin levels.
The counselling will be given on 2 occassions for about 20 minutes at 12-20 and 18-24 weeks of pregnancy , depending when women are recruited in study |
| Comparator Agent |
Routine antenatal care |
Routine antenatal care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women at 8 or more weeks gestation
Consenting women able to respond to study questions |
|
| ExclusionCriteria |
| Details |
Severe anemia, Hb less than 7 gm/dl
Chronic illness
Immunocompromised status |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mean haemoglobin of pregnant women |
28 weeks gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean minimum dietary diversity score for women
Mean MUAC
Number of eating occassions
Compliance to iron supplements
Iron and Calorie intake in diets
Mean probability of adequacy (MPA)of diet
% pregnant women consuming CAPPT promoted food
Ratios of MPA (women/husband)
Relative dietary energy adequacy ratios between pregnant woman and husband
|
28 weeks gestation |
|
|
Target Sample Size
|
Total Sample Size="1600"
Sample Size from India="1600"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2020 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Women are prone to become anemic during pregnancy . Hence, increase dietary intake of iron and oral iron supplements are recommended. Despite free oral iron supplements provided by the Govt of India, rates of anemia in Indian pregnant women is alarmingly high. Compliance to medication may be an issue, but other factors such as cultural and social beliefs, access to iron rich food sources. other micronutrient deficiencies, and inequalities to sharing and access to food in household are other significant factors why pregnant women remain anemic. It is important to prevent anemia in pregnancy as anemic women are more likely to die in pregnancy and give birth to low birth weight babies. In this study we will test the effectiveness of a household counselling intervention with tailored iron supplementation ( prophylactic or therapeutic dose depending on Hb levels as per Govt of India guidelines) and nutrition focussed participatory learning on improved dietary practices and reducing incidence of anemia in pregnancy, in rural India. The intervention will be delivered by community health workers. Counselling of pregnant women and their households (including men) supported by nutrition focussed groups in community will empower households to adopt dietary practices that enable real nutrional imprpvements. |