Gestational diabetes Pregnancy and Childbirth Diabetes mellitus arising in pregnancy
Conditions
Interventions
60 women who have recently received a diagnosis of GDM will be recruited and block randomisation in blocks of 10 will be used to randomly assign 30 women to receive the intervention and 30 to receive
Sponsors
King's College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged =18 years 2. Diagnosed with GDM (NICE criteria) 3. =30 weeks pregnant 4. Able to speak and understand English 5. Access to the internet 6. Body mass index (BMI) of = 25 kg/m2 (or =22 kg/m2 if Asian)
Exclusion criteria
Exclusion criteria: 1. Unable to consent 2. Under 18 years 3. =31 weeks pregnant 4. BMI <24, or <22 in Asian ethnic groups 5. Unable to speak and understand English 6. Serious mental illness 7. No access to the internet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of the trial, measured through: acceptability (recruitment, retention, acceptability of intervention and data collection procedures for participants), practicality (fidelity, acceptability for clinic staff and intervention facilitators); Timepoint(s): End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Glucose tolerance is measured using a two hour fasting oral glucose tolerance test (OGTT) at baseline, 6 and 12 months 2. Average plasma glucose concentration is measured using glycated haemoglobin (HbA1c) at baseline, 6 and 12 months 3. Blood pressure is measured using a blood pressure cuff at baseline, 6 and 12 months 4. Weight is measured using digital scales at 6 and 12 months. Baseline weight is taken from pre-existing medical records for weight at pregnancy booking appointment 5. Waist circumference is measured using a tape measure at 6 and 12 months 6. Depression is measured using Patient Health Questionnaire (PHQ) 9 at baseline, 6 and 12 months 7. Postnatal depression is measured using the Edinburgh Postnatal Depression Scale at baseline, 6 and 12 months 8. Quality of life is measured using EuroQol EQ-5D-5L at baseline, 6 and 12 months 9. Body image is measured using the Body Appreciation Scale (BAS) at baseline, 6 months and 12 months 10. Eating behaviour is measured using an adapted version of the Three Factor Eating Questionnaire at baseline, 6 months and 12 months 11. Motivation to change is measured using the Dietary Change Motivation Scale at baseline, 6 and 12 months 12. Diabetes risk perception is measured using the Risk Perception Survey for Developing Diabetes at baseline, 6 and 12 months 13. Dietary intake is measured using the Multiple Pass 24 hour Diet Recall online questionnaire (INTAKE) at baseline, 6 and 12 months 14. Physical activity is measured using an adapted version of the Global Physical Activity Questionnaire (GPAQ) and 4 day accelerometer at baseline, 6 and 12 months 15. Sleep is measured using 6 questions on sleep at baseline, 6 and 12 months 16. Infant feeding intentions are measured using the | — |
Countries
England, United Kingdom
Outcome results
None listed