Stay Active: a smartphone application to support the delivery of a physical activity intervention in women with gestational diabetes

Not Applicable

• Conditions: Physical activity in women with gestational diabetes mellitus (GDM); Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN11366562
• Lead Sponsor: Oxford University Hospitals NHS Trust

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36171028/ (added 29/09/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38745288/ (added 20/05/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-11
• Last Update Posted: 3 June 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 67

Inclusion Criteria

Current inclusion criteria as of 15/08/2022:
1. Women who are more than 20 completed weeks pregnant and less than 33 completed weeks pregnant with a singleton pregnancy
2. Abnormal Oral Glucose Tolerance Test (OGTT) as defined by IADPSG, HbA1C, fasting plasma glucose or random blood glucose as defined by RCOG Guidance for maternal medicine services in the evolving coronavirus (COVID-19) pandemic.
3. Using GDm-Health to monitor their blood glucose
4. Aged between 18 and 45 years
5. Willing and able to provide informed consent for participation in the study
6. Have, and use, a smartphone

Previous inclusion criteria:
1. Women who are more than 24 completed weeks pregnant and less than 33 completed weeks pregnant with a singleton pregnancy
2. Abnormal Oral Glucose Tolerance Test (OGTT) as defined by IADPSG, HbA1C, fasting plasma glucose or random blood glucose as defined by RCOG Guidance for maternal medicine services in the evolving coronavirus (COVID-19) pandemic.
3. Using GDm-Health to monitor their blood glucose
4. Aged between 18 and 45 years
5. Willing and able to provide informed consent for participation in the study
6. Have, and use, a smartphone

Exclusion Criteria

1. Multiple pregnancy
2. GDM not diagnosed by OGTT, HbA1C or fasting plasma glucose as defined by RCOG Guidance for maternal medicine services in the evolving coronavirus (COVID 19) pandemic
3. An absolute contra-indication to physical activity as per 2019 Canadian guidelines (Mottola M et al, 2018) e.g. preterm rupture of membranes, limited mobility, haemodynamically significant heart disease, restrictive lung disease
4 Unable to understand written or spoken English language

Study & Design

• Study Type: Interventional
• Study Design: Not specified