None listed
Conditions
Brief summary
Over 22,000 pregnant women in Australia each year (7.7% of pregnancies) develop Borderline Gestational Diabetes Mellitus (GDM). The primary aim of the IDEAL Study is to assess whether dietary and lifestyle advice and treatment given to pregnant women who have borderline gestational diabetes on screening for gestational diabetes (defined as a positive oral glucose challenge screening test (OGCT) followed by a normal oral glucose tolerance test (OGTT)), reduces neonatal complications and maternal risks. The primary hypothesis of the study is that dietary and lifestyle advice and treatment given to women who have borderline gestational diabetes on screening for gestational diabetes will reduce the incidence of large for gestational age infants defined as birthweight above the 90th centile for gestation and fetal sex on standardised birthweight charts. If treatment of these women is effective this would reduce the burden of disease for women and their babies, with implications for improved health through childhood, adolescence and adulthood.
Interventions
Intervention Group: women in the 'Intervention Group' will be advised that their oral glucose tolerance test (OGTT) results are normal but that they have borderline glucose intolerance. These women will receive a single face-to-face session of approximately 45 minutes duration providing individualised dietary and lifestyle advice from a qualified dietician, based on published recommendations of the Dieticians Association of Australia, that are culturally appropriate and meet the nutritional req
Intervention Group: women in the 'Intervention Group' will be advised that their oral glucose tolerance test (OGTT) results are normal but that they have borderline glucose intolerance. These women will receive a single face-to-face session of approximately 45 minutes duration providing individualised dietary and lifestyle advice from a qualified dietician, based on published recommendations of the Dieticians Association of Australia, that are culturally appropriate and meet the nutritional requirements of pregnancy. The following characteristics of the mother: age, pre-pregnancy weight, activity level, current dietary intake and weight gain for the current and previous pregnancies will be considered in developing an individualised diet and exercise plan. Written information will be provided to the women detailing their dietary and exercise goals during pregnancy. This session with the dietician is to be scheduled as soon as possible after study enrolment (between 24 weeks and 34 weeks 6 days gestation). At each routine antenatal visit from enrolment until birth, women will have their weight recorded, blood glucose monitoring and further treatment, if appropriate. Progress with their dietary and exercise goals will be reviewed with their health professional. All other pregnancy care to be provided by the attending obstetric team according to current clinical practice in hospitals in Australia. They will be asked to complete a questionnaire on health related quality of life at 36 weeks gestation. They will also be asked about their physical activity and dietary habits.
Sponsors
Women's and Children's Hospital, Adelaide, SA.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Not stated to 50 Not stated
Healthy volunteers
No
Inclusion criteria
Women between 24 weeks 0 days and 34 weeks 6 days gestation with a singleton pregnancy, with a positive OGCT (venous plasma glucose >=7.8 mmol/L) and a normal 75 gram OGTT (fasting venous plasma glucose <5.5 mmol/L and a 2 hour glucose <7.8 mmol/L), who give written, informed consent.
Exclusion criteria
Women with known diabetes mellitus, previously treated GDM, active chronic systemic disease (except essential hypertension and mild forms of asthma) or a multiple pregnancy.
Outcome results
None listed