| CTRI Number |
CTRI/2022/09/045547 [Registered on: 15/09/2022] Trial Registered Prospectively |
| Last Modified On: |
23/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the effect of family based educational intervention on haemoglobin,calcium and vitamin D status, mothers outcomes and childrens outcomes among pregnant women at Thiruvallur district, Tamil Nadu. |
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Scientific Title of Study
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A study to evaluate the effectiveness of family focused experiential learning intervention on micronutrients, maternal and infant outcomes among rural antenatal women at Thiruvallur district, Tamil Nadu. |
| Trial Acronym |
|
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRATHEESHA |
| Designation |
PHD RESEARCH SCHOLAR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
SRI RAMACHANDRA FACULTY OF NURSING
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9176665996 |
| Fax |
|
| Email |
ipratheesha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARUNA |
| Designation |
READER AND HOD OF COMMUNITY HEALTH NURSING |
| Affiliation |
SRI RAMACHANDRA FACULTY OF NURSING |
| Address |
SRI RAMACHANDRA FACULTY OF NURSING
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9444412607 |
| Fax |
|
| Email |
aruna.s@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
PRATHEESHA |
| Designation |
PHD RESEARCH SCHOLAR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
SRI RAMACHANDRA FACULTY OF NURSING
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9176665996 |
| Fax |
|
| Email |
ipratheesha@gmail.com |
|
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Source of Monetary or Material Support
|
| SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
|
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Primary Sponsor
|
| Name |
Pratheesha |
| Address |
SRI RAMACHANDRA FACULTY OF NURSING
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
PORUR
CHENNAI
600116 |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PRATHEESHA |
PRIMARY HEALTH CENTER |
PRIMARY HEALTH CENTER
THIRUVALLUR DISTRICT
TAMIL NADU.
Thiruvallur
TAMIL NADU |
9176665996
ipratheesha@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| NOC of Directorate of Public Health Department |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O251||Malnutrition in pregnancy, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
the control group of rural antenatal women will be pre-tested for Biochemical analysis, clinical variables, Knowledge, practice questionnaire, and Semi-quantitative food frequency questionnaire at enrollment. the researcher will provide only general education (hygiene, sanitation, rest, and exercise) to the control group. post-test-I will be done at 37 weeks of gestation. post-test -II will be done 6 months after delivery and post-test -III will be done 12 months after delivery same as the like intervention group
|
| Intervention |
Family Focused Experiential Learning Intervention |
Intervention:
Family-focused experiential learning intervention (FFELI) consisted of listening and discussing nutrition-related information and experiences such as demonstrations, skills-building, game and role play. The materials, combined with the on-going comprehensive enhanced community conversations (ECC) activities, supported an experiential learning approach to help mothers, spouse and grandmothers build on the knowledge, attitude, experiences and skills they already have and, in turn, practice the adoption of positive behavior roles .
After selecting 16 PHC for study group and control group . all the mothers will be screened for anemia then mother who fulfill the inclusion criteria list will be prepared from the list 15 to 24 mother will be selected randomly from each PHC. The FFELI intervention will be given to rural antenatal women and their family member through two phases for the intervention group and general education with routine care only for the control group. During Phase -I education intervention on micronutrients (iron, calcium, vitamin D) will be implemented. it consists of 4 interactive teaching/discussion/ demonstration/card game and food selection workshop session once in two weeks for 40 minutes from enrolment to 4 consecutive weeks on a group basis (7-9 members) of rural antenatal women and their family member. At the end of each session, education materials on micronutrients (iron, calcium, vitamin D) will be distributed.
Phase -II- intervention is follow up, during this phase 2 home visit will be conducted once in a month for two months to reinforce play way and experiential learning to promote the purchase and consumption of micronutrient rich foods and to enhance community conversations (ECC) activities among mothers, spouse and grandmothers build on the knowledge, attitude, experiences and skills they already learned in phase 1 and, in turn, practice the adoption of positive behavior. Post-test I will be performed 8 weeks after the pretest. Following that, till 12 months after delivery, a biweekly phone call of about 3–5 minutes will be done as follow-up to know the situation of maternal women and infant and convey key messages on micronutrients (iron, calcium, vitamin D), exclusive breastfeeding and complementary feeding. Post-test II will be performed 6 months after delivery. Post -test – III will be performed 12 months after delivery.
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
This study includes Rural Antenatal Women who are:
1. Above 18 to 35 years and from 12 weeks to 28 weeks of gestation
2. Rural antenatal women with Mild anemia-10-10.9gm/dl and Moderate anemia-7.1-10gm/dl (as per ICMR)
3. Who can understand Tamil and English
4. Those who are coming for a regular antenatal check-up .
|
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| ExclusionCriteria |
| Details |
This study excludes rural antenatal women who are:
1. with co-morbidities like (kidney and liver disease)
2. Diagnosed psychiatric illness.
3. Severe Anemia |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Blinding/Masking
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Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| the level of hemoglobin, calcium, and vitamin D among rural antenatal women. |
6 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
MATERNAL OUTCOMES : Knowledge and practice assessment, Dietary pattern, Gestational weight gain, gestational age at birth, mode of delivery, Apgar score, birth weight of new-born, maternal and fetus/new-born complications during antenatal, intranatal, and postpartum phase.
|
6 months |
INFANT OUTCOMES:
infant growth and development (Cognitive, motor, socio-emotional, language, and adaptive behavior) and also infants’ length-for-age, weight-for-age, and weight-for-length. |
6 months |
|
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Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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NOT YET PUBLISHED |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This study is a randomized control trial. This study is evaluating the effectiveness of family-focused experiential learning intervention for 7 months and 18 months of follow-up in 140 (70 in the intervention group and 70 in the control group) rural antenatal women in Thiruvallur district, Tamil Nadu, India. The primary outcome measures will be hemoglobin, calcium, and vitamin D status among rural antenatal women at enrollment (12 – 24 weeks of gestation), 37 weeks of gestation, and 6 months after delivery. The maternal secondary outcome measures will be knowledge, practice assessment, dietary pattern at enrollment (12 – 24 weeks of gestation), 37 weeks of gestation, and 6 months after delivery. Gestational weight gain, gestational age at birth, mode of delivery, Apgar score, birth weight of the newborn, and maternal and fetus/newborn complications during antenatal, intranatal, and postpartum phase will be recorded after delivery. The infant’s secondary outcome measures will be Cognitive, motor, socio-emotional, language, and also infant length-for-age, weight-for-age, and weight-for-length at 6 months and 12 months of the infant. |