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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
Sponsor:
Collaborators:
Northern Health and Social Care Trust
South Eastern Health and Social Care Trust
Interreg
Our Lady of Lourdes Hospital, Drogheda
Sligo General Hospital
Letterkenny University Hospital
Information provided by (Responsible Party):
Belfast Health and Social Care Trust

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Weight Loss Gestational Diabetes Other: PAIGE2 lifestyle intervention Other: Standard care Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard care
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


Outcome Measures
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Primary Outcome Measures :
  1. Weight loss [ Time Frame: Change from baseline to 12 months postpartum ]
    Weight loss


Secondary Outcome Measures :
  1. Fasting glucose [ Time Frame: Change from baseline to 12 months postpartum ]
    Fasting glucose

  2. Waist circumference [ Time Frame: Change from baseline to 12 months postpartum ]
    Waist circumference

  3. Step counts (intervention group only) [ Time Frame: Change from baseline to 12 months postpartum ]
    Number of steps taken

  4. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women aged 18 years of age or older,
  2. Women with a booking BMI ≥ 25 kg/m2 at <14 weeks gestation
  3. GDM has been diagnosed in their current pregnancy.
  4. Women will only continue to be included in the study if their fasting plasma glucose the morning after delivery indicates normality or impaired fasting plasma glucose outside of pregnancy (i.e.<7 mmol/l).

  5. Women with a history of GDM directly preceding the current pregnancy, and who were given lifestyle advice and were performing self-monitoring of blood glucose from early pregnancy, will also be included if capillary glucose monitoring exceeds target values (fasting ≥ 5.3 mmol/l (95 mg/dl), 1h postprandial plasma glucose ≥ 7.8 mmol/l (140 mg/dl) thus negating the need for an OGTT.

    -

    Exclusion Criteria:

    Pregnancy in which an anomaly has been detected on the 20-week fetal anomaly scan.

b.) History of diabetes outside of pregnancy or FPG ≥7 mmol/l the morning after delivery.

c.) History of heart, liver or chronic renal disease. d.) Medications that adversely affect glucose tolerance (e.g. steroids). e.) Inability to participate in moderate physical activity outside of pregnancy.

f.) Moderate/severe depressive illness or excess alcohol consumption. g.) Inability to understand adequately verbal explanations or written information in English, or special communication needs.

h.) Women who are planning another pregnancy within the next 12 months following delivery.

i.) Exclusion criteria for early post-partum glucose testing will include massive postpartum hemorrhage, steroid treatment prior to delivery or patient refusal.

  • If a woman requests an earlier discharge that does not allow time for the FPG test, she will be offered an appointment to return to the maternity unit within four weeks of birth for retesting.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Laura Cassidy +44 (0) 28963 3549 laurax.cassidy@belfasttrust.hscni.net

Locations
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United Kingdom
Royal Victoria Hospital Recruiting
Belfast, United Kingdom, BT12 6BA
Contact: Laura Cassidy    00442895044054 ext 44054    laurax.cassidy@belfasttrust.hscni.net   
Principal Investigator: David McCance         
Sponsors and Collaborators
Belfast Health and Social Care Trust
Northern Health and Social Care Trust
South Eastern Health and Social Care Trust
Interreg
Our Lady of Lourdes Hospital, Drogheda
Sligo General Hospital
Letterkenny University Hospital
Investigators
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Principal Investigator: David McCance Belfast Health and Social Care Trust
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT04579016    
Other Study ID Numbers: 18/NI/0228
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Overweight
Weight Loss
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Body Weight
Body Weight Changes
Pregnancy Complications