Participant Engagement and Retention Trial in a Public Hospital (PERTH): An RCT Protocol
Participant Engagement and Retention Trial in a Public Hospital (PERTH): An RCT Protocol
MAASTHI (Maternal Antecedents of Adiposity Studying the Transgenerational role of
 Hyperglycaemia and Insulin) is a prospective birth cohort with the aim of assessing the
 effects of glucose levels in pregnancy on the risk of adverse infant outcomes, especially in
 predicting the possible risk markers of later chronic diseases. The recruitment of the
 pregnant women in MAASTHI has begun in the month of April 2016. Of the eligible pregnant
 women only 77% completed the oral glucose tolerance tests.The follow ups of mother and child
 are conducted at birth and annually during the year 1, 2, 3 and 4 of the child. Despite
 stringent adherence of including only the residents of the source population, nearly 13% of
 the women were lost to follow-ups at birth. In order to prevent further loss to follow-ups in
 subsequent visits, the investigators aim to explore whether interventions involving
 innovative Interactive Voice Response System (IVRS) and conducting mother and baby workshops
 can improve in the number pf women undergoing lab tests and subsequent follow-ups.
Longitudinal cohort studies are important for the understanding of etiological mechanisms of
 underlying hypotheses. However, it is particularly challenging to sustain participation of
 subjects in follow up visits in birth cohorts, as the observation period spans over several
 years, making it vulnerable to lose tracking subjects for several reasons. These include
 change in location of residence and lack of interest in the later stages of the study. In
 India, the traditional practice of pregnant women leaving the study area to return to their
 maternal residence for delivery. Few groups belonging to ethnic minorities, with low family
 income or low education can be at higher risk of selective attrition. In the absence of high
 follow-up rate, the results from prospective cohort studies are can be biased. Such a bias
 can occur if the reason for the loss is related to the outcome under investigation. The
 cohort studies done in India have variable rates of loss to follow-up varying from, 14-82%.
 The barriers for retaining greater proportion of study participants can be due to several
 reasons. While a number of reviews have reported different ways of improving study
 participation, little is known about the effectiveness of specific retention strategies
 deployed in retention of mothers and infants in a birth cohort.

 The proportion of pregnant women turning up for regular antenatal health checkups is poor in
 India. This is due to several reasons including lack of awareness, lack of social support,
 long waiting time, financial constraints and fear of hospital care. Evidence suggests that
 maternal education, husband's education, marital status, availability, cost, household
 income, women's employment, media exposure and previous obstetric history affects uptake of
 antenatal care services. According to National Family Health Survey (NFHS) (2014-15), only
 55.5% of women in urban Bangalore had completed the required four antenatal care visits
 during pregnancy.

 MAASTHI (Maternal Antecedents of Adiposity Studying the Transgenerational role of
 Hyperglycaemia and Insulin) is a prospective birth cohort with the aim of assessing the
 effects of glucose levels in pregnancy on the risk of adverse infant outcomes, especially in
 predicting the possible risk markers of later chronic diseases. The recruitment of the
 pregnant women in MAASTHI has begun in the month of April 2016. Of the eligible pregnant
 women only 77% completed the oral glucose tolerance tests despite offering the test free of
 cost and repeated reminders by the research team to get tested for gestational diabetes.
 After completion of OGTT, the follow ups of mother and child are conducted at birth and
 annually during the year 1, 2, 3 and 4 of the child. Despite stringent adherence of including
 only the residents of the source population, nearly 13% of the women were lost to follow-ups
 at birth. These women delivered in a different hospital mostly due to obstetric
 complications. Currently around 80 participants are recruited per month, with completion of
 all their records, anthropometry measurements, and Oral Glucose Tolerance Test (OGTT). Once
 the OGTT is done between 24-32 weeks of gestation, there is no further opportunity to meet
 them again till the delivery. The duration without contact increases the likelihood for
 attrition of future follow-ups. In the intervening period of initial contact and follow-up's,
 it is important that the research staff constantly engage with the participants through
 innovative methods. In order to improve the number of women undergoing OGTT and follow-ups,
 an intervention trial will be carried out that examines the role of innovative 1) IVR and
 2)Mother and baby workshops during the intervening time period between baseline and
 follow-up.
Inclusion Criteria:

 Pregnant women between 14 to 28 weeks of gestational age and those who plan to deliver in
 the study hospital and reside in the study location for the next five years. She must be
 able to speak Kannada, Hindi or English and should be willing to provide informed consent
 voluntarily. The participant must own or have sufficient access to a cell phone and should
 be able to operate a cell phone with a partner, relative, etc who stay with her.

 Exclusion Criteria:

 -  Diabetes or Hepatitis B infection;

 -  HIV positivity;

 -  Pregnant women of other gestational ages