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Postnatal intervention for women with a history of gestational diabetes mellitus

PostnAtal lifestyle Intervention programme for overweight women with previous GEstational diabetes mellitus (PAIGE)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55443431
Enrollment
100
Registered
2013-06-14
Start date
2013-06-01
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postnatal women with a history of gestational diabetes in a recent pregnancy, and who are overweight Pregnancy and Childbirth Diabetes mellitus in pregnancy, unspecified

Interventions

The experimental arm will be enrolled in a lifestyle intervention comprising a one hour educational programme delivered during the time they attend for the routine postnatal oral glucose tolerance tes

Sponsors

Belfast Health and Social Care Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older 2. History of gestational diabetes mellitus in last pregnancy. The definition of GDM will be according to the new International Association of the Diabetes in Pregnancy Study Groups (IADPSG) consensus criteria (7), following a 75g oral glucose tolerance test (OGTT) (fasting glucose =5.1 mmol/l or 1h plasma glucose = 10 mmol/l or 2h plasma glucose =8.5 mmol/l). 3. Body mass index (BMI) = 25 kg/m2 at booking (if less than 16 weeks, otherwise based on reported pre pregnancy weight) and BMI = 25 kg/m2 at their postnatal OGTT visit. A BMI equivalent to 25 kg/m2 will be used for non Caucasian subjects. 4. Normal or impaired glucose tolerance or impaired fasting glucose (IFG/IGT) on postnatal glucose tolerance testing. 5. Mothers will be encouraged to continue to breast feed. The aim will be to recruit mothers who are not planning a further pregnancy in the next 6 months.

Exclusion criteria

Exclusion criteria: 1. Pregnancy outcome resulting in an anomaly or still birth 2. History of diabetes outside pregnancy or diagnosis of diabetes on the postnatal OGTT 3. Heart, liver, or chronic renal disease 4. Medications that adversely affect glucose tolerance (e.g. steroids) 5. Contraindications to participating in moderate physical activity 6. Moderate/severe depressive illness 7. Excess alcohol consumption 8. Planning another pregnancy in the next 6 months 9. Taking part in another research study 10. Inability to adequately understand verbal explanations or written information given in English, or who have special communication needs 11. Already attending a CWMO NB: Women will not know if they have a diagnosis of diabetes outside pregnancy until several days after the OGTT appointment (visit 1). Women who are diagnosed with persisting diabetes following the postnatal OGTT will be contacted by their diabetes care team for follow up and will be excluded from the study post randomisation.

Design outcomes

Primary

MeasureTime frame
Weight at 6 months (taking into account any difference in weight at baseline between the intervention and control groups)

Secondary

MeasureTime frame
1. Fasting glucose and 2h OGTT glucose (optional) 2. Waist circumference 3. Pedometer counts, change from baseline at 6 months (intervention group only) 4. Questionnaire data pertaining to physical activity, nutrient intake as estimated by food diary, General Health and Well Being, Motivation to change and Risk Perception Survey for Developing Diabetes (RPS-DD)

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026