| CTRI Number |
CTRI/2025/02/080693 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of Behaviour Change Communication(BCC) on dietary diversity among women of reproductive age group(15-49 Years) |
|
Scientific Title of Study
|
Effect of Behaviour Change Communication(BCC) on dietary diversity among women of reproductive age from different socio-demographic background: a cluster randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sujata Kapil Murarkar |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (DTU) Medical College Pune |
| Address |
Department of Community Medicine, Bharati Vidyapeeth (DTU) Medical College , Pune, Off Pune satara road, Katraj-Dhankawadi.
Pune
MAHARASHTRA
411043
India |
| Phone |
09011090147 |
| Fax |
|
| Email |
sujata.murarkar@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Kapil Murarkar |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (DTU) Medical College Pune |
| Address |
Department of Community Medicine, Bharati Vidyapeeth (DTU) Medical College , Pune, Off Pune satara road, Katraj-Dhankawadi.
Pune
MAHARASHTRA
411043
India |
| Phone |
9011090147 |
| Fax |
|
| Email |
sujata.murarkar@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sujata Kapil Murarkar |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (DTU) Medical College Pune |
| Address |
Department of Community Medicine, Bharati Vidyapeeth (DTU) Medical College , Pune, Off Pune satara road, Katraj-Dhankawadi.
Pune
MAHARASHTRA
411043
India |
| Phone |
09011090147 |
| Fax |
|
| Email |
sujata.murarkar@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Central Research and Publication Unit , Bharati Vidyapeeth Deemed to University , Pune -411030 |
|
|
Primary Sponsor
|
| Name |
Central Research and Publication Unit ,Bharati Vidyapeeth Deemed University , Pune |
| Address |
Central Research and Publication Unit , Bharati Medical College, Pune -411043 Maharashtra, India |
| Type of Sponsor |
Private 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 Sujata Kapil Murarkar |
Urban and Rural Field practice area of a private Medical college in Pune |
1.Urban Health Training Center Sadashiv Peth, Pune
2.Rural health Training Center Lavale, Mulshi Taluka, Pune district
Pune
MAHARASHTRA |
9011090147
sujata.murarkar@bharatividyapeeth.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Minimum Dietary Diversity among Women of reproductive age group(15-49 years) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention (Routine diet) |
Routine diet intake |
| Intervention |
Step I BCC activities for 3 months to promote dietary diversity Step II: Demonstration of healthy nutritious recipes from locally and seasonally available food items |
Step I BCC activities to promote dietary diversity
Step II for 3 months : Demonstration of healthy nutritious recipes from locally and seasonally available food items |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Non Pregnant and Non lactating women in reproductive age group (15-49Years) in the selected clusters |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women from the selected clusters. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Minimum dietary diversity score among women of reproductive age group |
Step1 and step 2 intervention will be for Three months each. Three months after step 2 intervention outcome will be studied |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in nutritional status of the women of reproductive age group (15-49 years) |
Nutritional status will be assessed by anthropometric measurements like height ,weight , waist to hip ratio .All these measurements will be taken twice. First during baseline data collection & second time it will be measured three months after step 2 intervention |
|
|
Target Sample Size
|
Total Sample Size="650"
Sample Size from India="650"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="12"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sujata.murarkar@bharatividyapeeth.edu].
- For how long will this data be available start date provided 01-09-2025 and end date provided 30-09-2040?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Contact on mail ID sujata.murarkar@bharatividyapeeth.edu
|
|
Brief Summary
|
Background: Low diet quality
of women of reproductive age group (WRA) will have an impact on their health
due to deficiency of important micronutrients. Indicator of assessing quality of the diet is Minimum
Dietary Diversity for Women (MDD-W). Objective:
To compare the dietary diversity among women of reproductive age group who
received intervention with among women who did not receive any intervention. Methodology: Two-armed Cluster
randomized controlled trial will be conducted in urban slums and rural area of
Pune district among women of reproductive age group. Estimated sample size will be of 325 participants in
each arm. Data on dietary diversity will be collected and classified into ten
food groups using 24-hour recall method. Behaviour change communication will be
provided in two steps. Statistical analysis will be done using univariate and
multivariate logistic regression, Chi-square test will be applied to test
association between different socio- demographic variables and risk factors in
the intervention and control arm. Conclusion: The study will
contribute to the existing literature on dietary diversity among women of the
15-49 years’ age group of urban and rural parts of India, informing future
research endeavors and policy initiatives. Key words: BCC, Dietary diversity, Women of reproductive
age group |