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.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Pratheesha
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- the level of hemoglobin, calcium, and vitamin D among rural antenatal women.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •This study includes Rural Antenatal Women who are:
- •Above 18 to 35 years and from 12 weeks to 28 weeks of gestation
- •Rural antenatal women with Mild anemia-10-10.9gm/dl and Moderate anemia-7.1-10gm/dl (as per ICMR)
- •Who can understand Tamil and English
- •Those who are coming for a regular antenatal check-up .
Exclusion Criteria
- •This study excludes rural antenatal women who are:
- •with co-morbidities like (kidney and liver disease)
- •Diagnosed psychiatric illness.
- •Severe Anemia.
Outcomes
Primary Outcomes
the level of hemoglobin, calcium, and vitamin D among rural antenatal women.
Time Frame: 6 months
Secondary Outcomes
- 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.)
- 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.