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

NCT04579016 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-10-08

No results posted yet for this study

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

Interventions

OTHER

PAIGE2 lifestyle intervention

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

OTHER

Standard care

Care routinely provided to all pregnant women diagnosed with GDM

Sponsors & Collaborators

  • Northern Health and Social Care Trust

    collaborator OTHER_GOV

  • South Eastern Health and Social Care Trust

    collaborator OTHER

  • Interreg

    collaborator OTHER

  • Our Lady of Lourdes Hospital, Drogheda

    collaborator OTHER_GOV

  • Sligo General Hospital

    collaborator OTHER

  • Letterkenny University Hospital

    collaborator UNKNOWN

  • Belfast Health and Social Care Trust

    lead OTHER

Principal Investigators

  • David McCance · Belfast Health and Social Care Trust

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04579016 on ClinicalTrials.gov