Pragmatic Lifestyle Pregnancy and Post Pregnancy Intervention for Overweight Women With Gestational Diabetes Mellitus (PAIGE2)
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|ClinicalTrials.gov Identifier: NCT04579016|
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Weight Loss Gestational Diabetes||Other: PAIGE2 lifestyle intervention Other: Standard care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pragmatic Lifestyle Pregnancy and Post Pregnancy Intervention for Overweight Women With Gestational Diabetes Mellitus: a Randomised Controlled Clinical Trial (PAIGE2)|
|Actual Study Start Date :||January 13, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Active Comparator: Standard care
Other: Standard care
Care routinely provided to all pregnant women diagnosed with GDM
Experimental: PAIGE2 intervention
One hour education session during pregnancy. Postnatally provision of activity tracker, 3/6 month referral to a commercial weight management organization, text and phone support.
Other: PAIGE2 lifestyle intervention
Education session during pregnancy. provision of fitness tracker, referral to commercial weight management organization, text and phone support
- Weight loss [ Time Frame: Change from baseline to 12 months postpartum ]Weight loss
- Fasting glucose [ Time Frame: Change from baseline to 12 months postpartum ]Fasting glucose
- Waist circumference [ Time Frame: Change from baseline to 12 months postpartum ]Waist circumference
- Step counts (intervention group only) [ Time Frame: Change from baseline to 12 months postpartum ]Number of steps taken
- Questionnaire data pertaining to physical activity, General Health and Well Being, Motivation to change and Risk Perception Survey for Developing Diabetes [ Time Frame: Change from baseline to 12 months postpartum ]Questionnaire data
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579016
|Contact: Laura Cassidy||+44 (0) 28963 email@example.com|
|Royal Victoria Hospital||Recruiting|
|Belfast, United Kingdom, BT12 6BA|
|Contact: Laura Cassidy 00442895044054 ext 44054 firstname.lastname@example.org|
|Principal Investigator: David McCance|
|Principal Investigator:||David McCance||Belfast Health and Social Care Trust|