Date

2022-12-27

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

The study will be carried out at the Castle Street Hospital for Women and the De Soysa Maternity Hospital. Participants will be invited to attend a special clinic in the department of Clinical Medicine, Colombo for data collection. A total of 100 postpartum women who meet the inclusion and exclusion criteria will be recruited soon after delivery (before discharge) from Castle Street Maternity Hospital for Women and De Soysa Maternity Hospital. Each of the 12 clinics will be randomized (cluster randomization) to be allocated either intervention or routine care (control). The participants registered at each clinic, will thus be allocated accordingly to the two arms. Arm A: Intervention arm (diet and physical activity modifications counseling) 1. Participants will undergo standardized individual counselling sessions by a trained investigator, lasting 30-60 minutes each. Session will address diet and exercise and a customized plan will be given. 2. Participants will be reviewed every 3 months for one year (total of 4 visits, including at the initial session). Diet and exercise plan will be adjusted based on pre-determined criteria in the outcomes. Based on pre-determined criteria, further counselling sessions lasting 30-60 minutes will be offered. 3. Standard management according to clinic protocols will continue. Arm B: Control arm Participants will receive only standard management according to clinic protocols.

Next Version

It After a lengthy discussion amongst the co-investigators it was decided to recruit mothers from Gampaha base hospital, Wathupitivala base hospital, Mahamodara teaching hospital and selected MOH areas in Gampaha and Galle district. (It was identified that there was a difficulty in finding the mothers after delivery because majority of mothers come to these hospitals from far away. Further most mothers visit their parent houses which is also away from the hospital., Hence it was not feasible to collect data from these hospitals). It was decided to recruit mothers who have conceived by assisted reproductive techniques as well in addition to those who were diagnosed as GDM 1st time in any pregnancy.