Promotion of Breastfeeding and Evaluation Study: a community-based maternal-focused approach to promote exclusive breastfeeding in rural Pakistan
| ISRCTN | ISRCTN45752079 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45752079 |
| Protocol serial number | N/A |
| Sponsor | University of Liverpool (UK) |
| Funders | United States Agency for International Development (USAID) (USA) - International Rescue Committee, Inc (IRC-PRIDE), University of Liverpool (UK) |
- Submission date
- 22/04/2009
- Registration date
- 29/06/2009
- Last edited
- 29/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Child & Adolescent Psychiatry
School of Population, Community & Behavioural Sciences
Royal Liverpool Children's Hospital
Eaton Road
Liverpool
L12 2AP
United Kingdom
| Phone | +44 (0)151 252 5509 |
|---|---|
| atif.rahman@liverpool.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomised single-blind parallel group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Integration and evaluation of a community-based maternal-focused approach to promote exclusive breastfeeding in rural Pakistan: a cluster randomised controlled trial |
| Study acronym | PROBE Study |
| Study objectives | The aim of this project is to provide the National Program for Family Planning and Primary Health Care of Pakistan and their Lady Health Workers (community health workers) with a well-researched, evidence-based intervention to promote exclusive breastfeeding, which has the potential for up-scaling. The objective of the project is to integrate a community-based exclusive breastfeeding promotion intervention into the routine work of Lady Health Workers, train them in using this approach, and to evaluate its effect on rates of exclusive breastfeeding. Hypotheses: Compared to mothers receiving standard breastfeeding advice by Lady Health Workers, mothers who receive the experimental intervention (also by Lady Health Workers) will: 1. Have a higher rate of exclusive breastfeeding (defined as giving maternal milk at the only infant food source in the previous week, with no other liquids or food given) at 6 months post-natally 2. Have a longer duration of exclusive breastfeeding 3. Have reduced levels of psychosocial distress |
| Ethics approval(s) | Human Development Research Foundation, registered with the Office of Human Research Protections (OHRP), gave approval on the 10th December 2008 (ref: HDRF/IRB/002) |
| Health condition(s) or problem(s) studied | Breastfeeding |
| Intervention | The proposed study is a cluster randomised controlled trial with two parallel arms. The intervention arm will receive seven sessions of this maternal focused approach to promote breastfeeding through Lady Health Workers. The control arm will receive a similar number of visits of routine counselling for breastfeeding through different Lady Health Workers. |
| Intervention type | Other |
| Primary outcome measure(s) |
All assessments will be carried out using instruments that have been translated, field-tested and validated in the local population through our previous work. Assessments will be carried out at baseline (third trimester), and prospectively for 6 months after birth. |
| Key secondary outcome measure(s) |
1. Psychological distress, measured at baseline, 3 and 6 months using the Self-Reporting Questionnaire (SRQ-20). This psychiatric screening instrument, which was developed specifically for use in primary care by health workers in developing countries, has 20 items with a 'yes' or 'no' response to questions about psychological and somatic symptoms in the past 30 days. |
| Completion date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 440 |
| Total final enrolment | 452 |
| Key inclusion criteria | 1. Married, consenting women 2. Aged 17 - 40 years 3. Pregnant; in their 3rd trimester of pegnancy |
| Key exclusion criteria | 1. A diagnosed medical or mental illness 2. Currently under treatment, e.g., tuberculosis, hepatitis B or C or a mental health illness |
| Date of first enrolment | 01/05/2009 |
| Date of final enrolment | 01/06/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
- Pakistan
Study participating centre
L12 2AP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2015 | 29/12/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.