A pilot randomised controlled implementation study to support women at high-risk of cardiometabolic pregnancy complications

Not Applicable

Recruiting

• Conditions: Reproductive Health and Childbirth - Other reproductive health and childbirth disorders; Type 2 Diabetes Mellitus; Cardiovascular - Hypertension; Hypertensive Disorders of Pregnancy; Diet and Nutrition - Other diet and nutrition disorders; Gestational Diabetes Mellitus; Cardiovascular Disease; Public Health - Health service research; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12624000401550
• Lead Sponsor: A/Prof Lisa Moran

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-03
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 230

Inclusion Criteria

Eligibility for Pregnancy Program:
Pregnant women (>18 years old) attending maternity services at Monash Health, identified as a ‘high-risk’ for developing GDM or HDP during their current pregnancy, as defined by the Monash GDM and/or HDP Risk Screening Tool (submitted for publication, awaiting acceptance), ability to speak and read in English, not currently participating in any other lifestyle-related clinical trial, has access to the internet (to view website and download resources), owns a mobile phone (in order to receive text messages).

For Postpartum Program: Participated in pregnancy program, has re-entered the postpartum program within 3-6 months of giving birth, developed either GDM and/or HDP during current pregnancy.

Exclusion Criteria

For Pregnancy Program: Unable to provide written consent, established diabetes (DM1 or DM2), previously known, established high blood pressure or hypertension, previously known, current or prior history of cardiovascular, cerebrovascular or peripheral vascular disease, in psychiatric care for substance abuse or mental illness, within last 3-months, cancer (not in remission), greater than 24 weeks gestation, current multiple pregnancy (e.g. twin, triplets), any clinically relevant acute illness or pregnancy complications (e.g., ectopic pregnancies, uterine or tubal anomalies, gastrointestinal conditions).

For Postpartum Program: Established T1DM after giving birth

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preventative screening for Type 2 Diabetes Mellitus[Short quantitative questionnaire, created by researchers for use in this trial 12-months after birth of the baby (postpartum)];Preventative screening for cardiovascular disease[Short quantitative questionnaire, created by researchers for use in this trial. 12-months after birth of the baby (postpartum)];Screening Uptake[A six-item scale is used to assess the participants perspective of perceived importance of screening tests for health, perceived self-efficacy and cues to action. 12-months after birth of the baby (postpartum).]