A randomised controlled trial to investigate the effect of a structured education programme on women who have had gestational diabetes and are at risk of developing type 2 diabetes

niversity of Leicester0 sites293 target enrollmentApril 5, 2017

Overview

Phase: 未知
Intervention: Not specified
Conditions: Specialty: Reproductive health and childbirth, Primary sub-specialty: Maternal/ Fetal medicine
Sponsor: niversity of Leicester
Enrollment: 293
Status: Completed
Last Updated: 2 years ago

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30541621 protocol 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34348719/ Participants' experiences of using the app (added 31/10/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37062022/ results (added 31/05/2023)

Registry

who.int

Start Date

April 5, 2017

End Date

December 31, 2018

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Sponsor

niversity of Leicester

•1\. A diagnosis of gestational diabetes in most recent pregnancy
•2\. Up to 36 months postnatal
•3\. Willing and able to attend the education sessions and clinic
•4\. Willing and able to give informed consent
•5\. Able to speak and read English to a sufficient level to understand the study and education programme
•6\. Telephone access
•7\. Aged 18 years and older

•1\. Currently has gestational diabetes
•2\. Currently pregnant at present
•3\. Type 1 or type 2 diabetes
•4\. Cancer (not in remission)
•5\. Severe diagnosed mental illness (e.g. Schizophrenia, bipolar)
•6\. Previous surgical or medical intervention to treat obesity
•7\. No access to internet
•8\. Does not have capacity to give informed consent
•9\. Participants who are currently participating or who have participated in another clinical intervention study in the previous 12 weeks
•10\. Unable to speak and read English to a sufficient level to understand the study and education programme