ifestyle interventions to prevent diabetes in pregnant mothers

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 1870

Inclusion Criteria

Current inclusion criteria as of 07/05/2020:

1. Aged 18 years or older
2. Gestational age = 16 weeks
3. Meeting at least one of the following criteria for high-risk gestational diabetes mellitus (GDM):
3.1. Booking BMI = 25kg/m²
3.2. Age = 25 years
3.3. First-degree relative with diabetes
3.4. Previous pregnancy with GDM
3.5. Previous pregnancy with large baby (= 3.5kg)
3.6. Previous pregnancy with pre-eclampsia/eclampsia
3.7. History of PCOD/impaired fasting glucose)
4. Not currently on any medications (except iron, calcium or folic acid supplements, thyroxine supplement for hypothyroidism, low dose aspirin for pre-eclampsia)

_____

Previous inclusion criteria:

1. Aged 18 years or older
2. Pregnant females
3. Gestational age >16 weeks
4. Meeting at least one of the following criteria for high-risk gestational diabetes mellitus (GDM):
4.1. BMI =25 kg/m² (for Indian women, BMI =23 kg/m²
4.2. First-degree relative with diabetes
4.3. Previous pregnancy with GDM
4.4. Previous pregnancy with a large baby (=3.5 kg)
4.5. Previous pregnancy with pre-eclampsia/eclampsia
4.6. History of polycystic ovary disease (PCOD) or impaired fasting glucose
5. Not currently on any medications (excluding iron or folic acid supplements)

Exclusion Criteria

Current inclusion criteria as of 07/05/2020:

1. GDM diagnosed prior to screening visit based on IADPSG criteria or documented
raised HbA1C, i.e., either fasting glucose = 5.1 mmol/L or 1h glucose = 10.0 mmol/L or 2h glucose = 8.5 mmol/L, or a documented HbA1c of = 6.5% at first booking
2. History of pre-gestational diabetes
3. Multiple gestations in the current pregnancy
4. History of severe hyperemesis in the first trimester
5. Uncontrolled pre-gestational or gestational hypertension (BP > 150/100 mmHg) on treatment
6. History of recurrent (= 2) first-trimester spontaneous abortions or stillbirths
7. Previous child born with congenital anomalies
8. History of significant ante- or post-partum haemorrhage in the previous pregnancy
9. Pregnancy following in-vitro fertilization or any assisted reproductive technology
10. Previous or current psychiatric illness on medication, epileptic seizures or on antiepileptic medication
11. Women meeting absolute contraindications for physical activity during pregnancy as recommended by the ACOG
11.1. Heart disease
11.2. Restrictive lung disease
11.3. incompetent cervix/cerclage
11.4. Pregnancies at risk for premature labour
11.5. gestational hypertension (BP > 150/100 mmHg)
11.6. Severe anaemia

_____

Previous exclusion criteria:

1. Diagnosis of pre-gestational diabetes, previous GDM based on The International Association of the Diabetes and Pregnancy Study Groups (IADPSG) criteria, or raised blood glucose at blooding - any of the following at first booking:
1.1. Fasting glucose =5.1 mmol/L
1.2. 1 hour glucose =10.0 mmol/L
1.3. 2 hour glucose =8.5 mmol/L
1.4. Documented HbA1c of =6.5%
2. Multiple gestation
3. History of severe hyperemesis in first trimester
4. History of hypertension (pre-gestational or gestational)
5. History or recurrent (more than two) first trimester abortions
6. History of ante- or post-partum haemorrhage in the previous pregnancy
7. Previous child born with congenital anomalies
8. Previous stillbirth or miscarriage
9. Pregnancy following in-vitro fertilisation or any assisted reproductive technology
10. Unwilling to adhere to the study protocol
11. History of or current psychiatric illness
12. History of or current neurological condition (i.e. epilepsy)
13. Meeting absolute contraindications for physical activity during preganncy as recommend by the American College of Obstetricians and Gynecologists (ACOG), including:
13.1. Heart disease
13.2. Restrictive lung disease
13.3. Incompetent cervix/cerclage
13.4. At risk for premature labour
13.5. Gestational hypertension
13.6. Severe anaemia

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 07/05/2020: <br><br>Incidence of gestational diabetes mellitus diagnosed based on IADPSG criteria at 26-28 weeks or fasting plasma glucose =5.1 mmol/l at week 32 (plasma glucose analysed using a Roche Cobas 800 Enzymic autoanalyser)<br><br>_____<br><br>Previous primary outcome measure:<br><br>Incidence of gestational diabetes mellitus according to IADPSG criteria, assessed by the following during weeks 26-28 of gestation and at 32 weeks of gestation:<br>1. Fasting plasma glucose, analysed using a Roche Cobas 800 Enzymic autoanalyser<br>2. Glucose at 1 and 2 hours post 75 g oral glucose tolerance test (OGTT), analysed using a Roche Cobas 800 Enzymic autoanalyser

Secondary Outcome Measures

Name	Time	Method

Related Trials