| CTRI Number |
CTRI/2025/02/080202 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Supportive community linkage] |
| Study Design |
Other |
|
Public Title of Study
|
Impact of supportive community linkage on management of breastfeeding problems |
|
Scientific Title of Study
|
Impact of supportive community linkage intervention for management of breastfeeding problems at community level-a Prospective intervention study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AIMS//IEC/36/2023 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anuradha Nadda |
| Designation |
Assistant professor |
| Affiliation |
Dr..BR Ambedkar State Institute of Medical Sciences |
| Address |
Room No. 402, 4th Floor. Dr BR Ambedkar State Institute of Medical Sciences,Mohali, Punjab.
Rupnagar PUNJAB 160059 India |
| Phone |
7986155044 |
| Fax |
|
| Email |
dranuradhapgims@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anuradha Nadda |
| Designation |
Assistant professor |
| Affiliation |
Dr. BR Ambedkar State Institute of Medical Sciences |
| Address |
Room no. 402, 4th Floor, Dr BR Ambedkar State Institute of Medical Sciences,Mohali, Punjab.
Rupnagar PUNJAB 160059 India |
| Phone |
7986155044 |
| Fax |
|
| Email |
dranuradhapgims@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anuradha Nadda |
| Designation |
Assistant professor |
| Affiliation |
Dr. BR Ambedkar State Institute of Medical Sciences |
| Address |
Room No. 402, 4th Floor, Dr. BR Ambedkar State Institute of Medical Sciences,Mohali, Punjab.
Rupnagar PUNJAB 160059 India |
| Phone |
7986155044 |
| Fax |
|
| Email |
dranuradhapgims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Model Rural Health Research Unit Bhunga Division Hoshiarpur, Directorates of Health and Family Welfare Punjab. Pin Code 144210 |
|
|
Primary Sponsor
|
| Name |
Model Rural Health Research Unit Bhunga |
| Address |
Model Rural Health Research Unit Bhunga Division Hoshiarpur, Directorates of Health and Family Welfare Punjab. Pin Code 144210 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anuradha Nadda |
Hoshiarpur-Block Bhunga and Chakkowal |
Room No. 101, Model Rural Health Research Unit Bhunga Division Hoshiarpur. Pin Code 144210 Hoshiarpur PUNJAB |
07986155044
dranuradhapgims@gmail.com |
| Dr Anuradha Nadda |
Mohali-Block Boothgarh & Derabassi. |
Room No. 402, 4th Floor, Dr BR Ambedkar State Institute of Medical Sciences Mohali, Punjab. Pin Code 160055 Rupnagar PUNJAB |
07986155044
dranuradhapgims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr BR Ambedkar State Institute of Medical Sciences, Mohali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All CHOs and ANMs of 4 blocks |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Community Linkage |
Community linkages: According to center for disease control and prevention (CDC) community linkages are connections between community and clinical sectors to improve health outcomes. Community and clinical sectors can be linked in five ways. In this project after training, if any ANMs and CHOs in group-1 will encounter any problem in the field related to lactation, they can video call or call any investigator for help in the initial 3 months. The investigators will support them telephonically/or in the OPD (in case referral is required) for the identification, management, and referral of lactation problems. Present study will use collaboration level for community linkage. |
| Comparator Agent |
Routine training |
Comparator group will receive 2 days training only. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All Axillary nurse midwiferies and community health officers of all 4 blocks who will give informed written consent. |
|
| ExclusionCriteria |
| Details |
Axillary nurse midwiferies and community health officers who will not give informed written consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Impact of supportive community linkage on skills and knowledge of breastfeeding problems of ANMs and CHOs.
Barriers and Facilitators for solving breastfeeding problems in the community |
At Baseline and after 6 months of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Barriers & facilitators in breastfeeding at community level |
After 6 months of follow up |
|
|
Target Sample Size
|
Total Sample Size="170" Sample Size from India="170"
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)
|
04/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rational
/gaps in existing knowledge: Many mothers find
breastfeeding challenging after leaving the hospital. ANM and CHO are important
part of the health system in rural India, if they get strengthened and
supported at community level, there is a likelihood of improved breastfeeding
practices rates.
Novelty: We will be able to generate evidence and recommend supported community
linkage for a few months to the ANM/CHOs by the trainers. An extensive literature review has
revealed paucity of data for intervention in India.
Objective:
To
compare the impact of supportive community linkage versus routine training on ANMs
and CHOs skills for managing breastfeeding problems. To find the barriers and facilitators for breastfeding in the community.
Methods:
The present study will be a prospective intervention study. Two blocks each from district Mohali & district
Hoshiarpur will be selected. In both districts; in one randomly
selected block (Group-1); all ANMs and CHOs will receive supportive community linkage & routine training, and in
another block (Group-2), only routine training for managing breastfeeding
problems will be given. All the ANMs and CHOs will receive training over 2 days. At the end of 2nd day, both
group’s knowledge will be checked by using a pre-tested, validated, semi-structured
questionnaire and skill assessment will be done by pre-identified, hypothetical
10 cases having lactation problems. A pre-tested, validated checklist will be
given to both groups for which agreement or disagreement for the correct
management will be later made by the investigators other than the study
investigator. Group 1 block will receive additional supportive community
linkage. Both groups will be followed up till six months
after intervention and after 6 months post-test will be done by the same
methodology as adopted for the pre-test with skill assessment in the field. |