Weight Loss Clinical Trial
Official title:
Pragmatic Lifestyle Pregnancy and Post Pregnancy Intervention for Overweight Women With Gestational Diabetes Mellitus: a Randomised Controlled Clinical Trial (PAIGE2)
This study is designed to determine if a postnatal lifestyle intervention will lead to weight reduction over a 12 month period post-delivery in women who have been diagnosed with gestational diabetes mellitus and who have a BMI greater that 25 compared to women who receive routine care.
Diabetes during pregnancy (Gestational Diabetes Mellitus (GDM) is defined as high blood
sugars during pregnancy and it is becoming increasingly common which affects around 18% of
pregnant women. GDM is usually diagnosed by an oral glucose tolerance test around 28 weeks
gestation. Women with previous GDM have a 50% risk of developing it again in any future
pregnancy, and are 7 times more likely to develop type 2 diabetes within the future compared
to women without GDM.
There is evidence that lifestyle changes (diet and physical activity), can reduce the
development of type 2 diabetes in people at high risk, such as women with previous GDM. The
postnatal period (shortly after pregnancy) is an ideal time for women to make these changes
to help prevent weight gain between pregnancies and generally reduce their risk of future
type 2 diabetes. This study is designed to determine if a postnatal lifestyle intervention
will lead to weight reduction over a 12 month period post-delivery.
Women who have been diagnosed with diabetes during pregnancy (GDM) and had a body mass index
(BMI) >25 kg/m2 at the start of pregnancy, will be invited to take part in the study.
During their routine appointment at 32-36 weeks gestation women will be randomly allocated
either to the intervention program or control group.
Women in the intervention group, will receive a 1-hour educational session during their
routine diabetes antenatal clinic visit. In addition, they will be offered an activity
tracker (following consent) to help monitor their daily step count and physical activity.
Women in both the intervention and control groups will have a fasting glucose blood sample
taken the morning after delivery. Those women with normal or borderline fasting glucose
levels are eligible to remain in the study, but those with type 2 diabetes will be excluded
and referred to their local diabetes team.
At 6-8 weeks postnatally, both groups will complete some questionnaires, give a blood sample,
have weight and blood pressure measurements recorded. Women will be offered free referral to
a commercial weight management organization for 12 weeks, with a possible extension for
another 12 weeks). Over the 12 months of the study, the PAIGE2 team will contact participants
intermittently by text and telephone to encourage them to eat healthily and increase their
physical activity. If the participants' partner is also willing to take part, the partner
will be sent an activity tracker to monitor physical activity and the research team will keep
in intermittent contact with the partner by text and telephone during the study.
Women allocated to the control group will be offered a free 12-week referral to a commercial
weight management organization at the end of the study.
Both groups will be asked to attend 2 further study visits at 6 and 12 months after delivery.
This will involve completion of some questionnaires, a blood test, weight and blood pressure
measurements.
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