FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
Close