Pragmatic Lifestyle Pregnancy and Post Pregnancy Intervention for Overweight Women With Gestational Diabetes Mellitus

NCT04579016 | Unknown

• 1 other identifier: 18/NI/0228
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Weight loss

  Change from baseline to 12 months postpartum

Secondary Outcomes (4)

• Fasting glucose

  Change from baseline to 12 months postpartum

• Waist circumference

  Change from baseline to 12 months postpartum

• Step counts (intervention group only)

  Change from baseline to 12 months postpartum

• Questionnaire data pertaining to physical activity, General Health and Well Being, Motivation to change and Risk Perception Survey for Developing Diabetes

  Change from baseline to 12 months postpartum

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Standard care

Other: Standard care

PAIGE2 intervention

EXPERIMENTAL

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

Interventions

PAIGE2 lifestyle intervention OTHER

Education session during pregnancy. provision of fitness tracker, referral to commercial weight management organization, text and phone support

PAIGE2 intervention

Standard care OTHER

Care routinely provided to all pregnant women diagnosed with GDM

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years of age or older,
• Women with a booking BMI ≥ 25 kg/m2 at \<14 weeks gestation
• GDM has been diagnosed in their current pregnancy.
• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead
• Northern Health and Social Care Trust: collaborator
• South Eastern Health and Social Care Trust: collaborator
• Interreg: collaborator
• Our Lady of Lourdes Hospital, Drogheda: collaborator
• Sligo General Hospital: collaborator
• Letterkenny University Hospital: collaborator

Study Sites (1)

Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

RECRUITING

Related Publications (1)

• McAuley E, Fleck O, Cassidy L, Kemp BJ, Cupples G, Kelly B, Creighton RM, Graham U, Wallace H, Patterson CC, McCance DR. A pragmatic lifestyle intervention for overweight and obese women with gestational diabetes mellitus (PAIGE2): A parallel arm, multicenter randomized controlled trial study protocol. Front Clin Diabetes Healthc. 2023 Mar 24;4:1118509. doi: 10.3389/fcdhc.2023.1118509. eCollection 2023.

  PMID: 37034478 DERIVED

MeSH Terms

Conditions

Weight Loss; Diabetes, Gestational

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• David McCance

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Cassidy

CONTACT

+44 (0) 28963 3549; laurax.cassidy@belfasttrust.hscni.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: January 13, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)