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Trial registered on ANZCTR


Registration number
ACTRN12617000443392
Ethics application status
Approved
Date submitted
24/02/2017
Date registered
27/03/2017
Date last updated
27/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Communities Singing about Health Messages for a Healthy Pregnancy Creates Awareness of Pathways to Safer Pregnancy and Childbirth in Households in Rural Nepal
Scientific title
Effectiveness of Communities Singing Health Messages to Create Awareness of pathways to Safer Pregnancy and Childbirth in Rural Nepal: randomised cluster design study
Secondary ID [1] 291204 0
None
Universal Trial Number (UTN)
U1111-1193-1890
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Maternal Health 302116 0
Condition category
Condition code
Reproductive Health and Childbirth 301734 301734 0 0
Antenatal care
Public Health 301781 301781 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the Parbat district of Nepal, four rural Village Development Committees were randomly grouped (two each) into two clusters. A structured questionnaire was used to collect baseline and post-intervention data. An equal number of adult male and female heads of households were invited for the interview. Consents were sought from the respective Village Development Committees, schools and respondents involved.
In the intervention cluster, Community members were invited to write health song lyrics which were later presented in a song competition organised and judged by the community. To facilitate this process to happen, a total of 23 orientation sessions were organised for teachers, students, mothers group members and youths about the key health message area (below).
These orientation sessions were delivered by the research student (Binod B Sharma)who comes from Nepal and knows the local language and culture. These sessions were organised in the schools, villages, small townships of the village and in the working fields wherever people were available.
Sessions were organised in a group environment.
In addition to the information about the key message area for songwriting, he discussed the song competition program to be held in the community. Each orientation session took approximately 90 minutes to deliver and clarify the questions. The key message areas below were the subject of discussion during the orientation session. This was to orient them on the areas in which they will be writing song lines. In each 23 sessions, the uniform message about the key message areas and competition program were discussed.
There were 26 groups of people participated in the song competition. The most accailamed songs were taken to the intervention for house to house singing progression.
Given the overwhelming participation of the community and the culturally appropriate method of diffusion, teachers were enthusiastic to take on the role of disseminating the health messages in the community. The teachers, school management committees, village secretaries, and others decided the composition of the singing team. The training for both intervention teams was organised in Ramja Deurali. During training, there were sufficient rehearsals of the songs to ensure their smooth presentation in the field. During training, participants prepared a specific intervention plan for their area with the route of the intervention. Local teachers then led the awareness program, singing the health messages in a house to house community progression.
The singing sessions were continued from morning until evening while organising in the village to village environment. The singing session normally took around 75 minuses per session.
In the Chitre Village Development Committee, a group of six teachers were identified for the singing intervention. The Chitre intervention progression was completed in ten days, from 14th to 23rd July 2016.

In Ramja Deurali, one teacher was nominated to lead the team. Other members of the group included a traditional singer, adolescents, former students, and one local villager. The progression in Ramja Deurali took eight days, from 5th to 12th August 2016.

A total of 80 singing sessions were organised covering all the households in the intervention cluster. The sessions were essentially held wherever people were present; for example, they were held in individual houses, in the common area of the village, schools, on the roads, and even in the fields where a group of people were working. A total of 2,369 people attended and listened to the health messages. A town crier was mobilised to inform villagers of the program just before the singing commenced at each group of houses.

An information sheet of key message areas was distributed to respective group members.
Key message areas:
1. Antenatal examination
a. Minimum of four antenatal visits during pregnancy.
2. Food
a. Pregnant women should eat food in every four hours.
b. Pregnant woman should take a balance of four foods - rice, vegetables, meat and maize. The recommended Iron tablets should be taken with milk if necessary.
3. Rest
a. Eight hours (a pair of four hours) of unbroken sleep is essential for the pregnant woman.
b. To ensure a healthy baby, the pregnant woman should not be engaged in heavy work and long hours of work after four months of pregnancy. They should make sure to rest with the weight off their feet every four hours.
4. Preparation for childbirth
a. Four key people (father-in-law, mother-in-law, husband and female community health volunteer) should engage in planning for childbirth.
b. They should inform health facility or skilled health worker before four weeks of the expected date of delivery.
c. The plan of transportation should be finalised four days before the expected date of delivery.
The winning songs were taught to local teachers, traditional singers and students who sang the songs in the villages. Songs were sung every day for the period of the intervention. A pictorial wall chart with the key health messages was distributed to each household.

In Chitre Village Development Committee the intervention was completed in ten days (from 14th to 23rd July 2016) and in Ramja Deurali Village Development Committee in eight days (from 5th to 12th August 2016).
Intervention code [1] 297264 0
Prevention
Comparator / control treatment
In the comparator, the intervention was not provided. The knowledge on the theme of the intervention compared before and after intervention between intervention and control population.
Control group
Active

Outcomes
Primary outcome [1] 301202 0
Knowledge of the importance of antenatal care assessed by semi-structured interview.
Timepoint [1] 301202 0
At baseline and post-intervention

Given the local situation, the assessment of outcomes (post-intervention survey) was organised immediately after the intervention were completed. It took about ten days in the first village and eight days in the second village to complete post-intervention survey.
Primary outcome [2] 301504 0
Knowledge of the importance of a supplemented diet during pregnancy assessed by semi-structured interview.
Timepoint [2] 301504 0
At baseline and post-intervention
Given the local situation, the assessment of outcomes (post-intervention survey) was organised immediately after the intervention were completed. It took about ten days in the first village and eight days in the second village to complete post-intervention survey.
Primary outcome [3] 301505 0
Knowledge of the importance of planning for the birth assessed by semi-structured interview.
Timepoint [3] 301505 0
At baseline and post-intervention
Given the local situation, the assessment of outcomes (post-intervention survey) was organised immediately after the intervention were completed. It took about ten days in the first village and eight days in the second village to complete post-intervention survey.
Secondary outcome [1] 332068 0
None
Timepoint [1] 332068 0
None

Eligibility
Key inclusion criteria
Inclusion criteria for baseline and post-intervention surveys:
1) Heads of households aged 18 years or above,
2) Household belongs to either Chitre, Ramja Deurali, Mudikuwa and Falebas Khanigaun villages,

Inclusion criteria for intervention (singing sessions)
1. Household and schools within the intervention (Chitre and Ramja Deurali) Village Development Committees
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects not meeting the qualification as the head of the household and
residing beyond the intervention cluster.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each cluster was made up of two adjoining Village Development Committees. First, we grouped the adjoining Village Development Committees into two groups. Then we wrote the name of the villages on the piece of paper and placed them in envelopes. The envelopes were labelled either ‘heads’ or ‘tails’. We decided whichever groups won the first coin toss would be assigned to the intervention group. We then arranged for an independent person (Dr Cheng) who was not informed of the groups to toss a coin to assign the pair of Village Development Committees the status of either intervention or control. Through this randomization process, Chitre and Ramja Deurali Village Development Committees were assigned as intervention cluster and Mudikuwa and Falebas Khanigaun as the control. The participants of each cluster were not informed of the design of the research as intervention and control. However, the village officials were informed and consent sought for the research activities planned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2016
Date of last participant enrolment
Anticipated
Actual
25/07/2016
Date of last data collection
Anticipated
Actual
19/08/2016
Sample size
Target
1547
Accrual to date
Final
1510
Recruitment outside Australia
Country [1] 8687 0
Nepal
State/province [1] 8687 0
District Parbat

Funding & Sponsors
Funding source category [1] 295649 0
University
Name [1] 295649 0
The University of Newcastle, Australia
Country [1] 295649 0
Australia
Funding source category [2] 295713 0
Charities/Societies/Foundations
Name [2] 295713 0
Hunter Medical Research Institute Jennie Thomas Project and Travel Grant
Country [2] 295713 0
Australia
Primary sponsor type
University
Name
The University of Newcastle, Australia
Address
The University of Newcastle
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 294577 0
None
Name [1] 294577 0
Address [1] 294577 0
Country [1] 294577 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296968 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 296968 0
Ethics committee country [1] 296968 0
Australia
Date submitted for ethics approval [1] 296968 0
01/12/2015
Approval date [1] 296968 0
14/03/2016
Ethics approval number [1] 296968 0
H-2015-0451

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72570 0
Prof Roger Smith AM
Address 72570 0
Director
Mothers and Babies Research Centre
Lot 1 Kookaburra Circuit New Lambton Heights NSW 2305
Locked Bag 1
Hunter Region Mail Centre
NSW 2310
Country 72570 0
Australia
Phone 72570 0
+61 2 24014374
Fax 72570 0
+61 2 24014394
Email 72570 0
Roger.Smith@newcastle.edu.au
Contact person for public queries
Name 72571 0
Binod Bindu Sharma
Address 72571 0
Mothers and Babies Research Centre
Lot 1 Kookaburra circuit,
New Lambton Heights NSW 2305
Australia
Country 72571 0
Australia
Phone 72571 0
+61 424891346
Fax 72571 0
Email 72571 0
BinodBindu.Sharma@uon.edu.au
Contact person for scientific queries
Name 72572 0
Roger Smith
Address 72572 0
Mothers and Babies Research Centre
Lot 1 Kookaburra circuit,
New Lambton Heights NSW 2305
Australia
Country 72572 0
Australia
Phone 72572 0
+61 2 24014374
Fax 72572 0
+61 2 24014394
Email 72572 0
Roger.Smith@newcastle.edu.au

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Results publications and other study-related documents

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