Implementation and evaluation of co-designed strategies with Aboriginal and Torres Strait Islander women aiming to reduce diabetes-related risks before, during and after pregnancy

Not Applicable

Recruiting

• Conditions: Reproductive Health and Childbirth - Other reproductive health and childbirth disorders; Diabetes in pregnancy (including gestational diabetes, overt diabetes in pregnancy and pre-existing diabetes); Obesity; Metabolic and Endocrine - Diabetes; Public Health - Health promotion/education; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Reproductive Health and Childbirth - Antenatal care; Reproductive Health and Childbirth - Breast feeding; Reproductive Health and Childbirth - Childbirth and postnatal care; Reproductive Health and Childbirth - Contraception

• Registration Number: ACTRN12624000850572
• Lead Sponsor: Menzies School of Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-09
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Three participant groups:

1. Aboriginal and Torres Strait Islander women between 16-45 years of age who have had an experience of diabetes in pregnancy - defined as All Aboriginal and Torres Strait Islander women who are between the ages of 16-45 and who have connections with the study site (i.e. living in the community, and/or who have received health care at the community’s clinic) and who have an experience of diabetes in pregnancy (any type of diabetes and at any point during the woman’s life)
2. Aboriginal and Torres Strait Islander community members above the age of 16 including family members - defined as community members residing in the study sites and who are over the age of 16
3. Health professionals, health stakeholders, community stakeholders (councils, NGOs), researchers and advocates - defined as either members of the health workforce or community services (clinic, NGOs, councils) who are interested in diabetes prevention/management (all over the age of 16) OR those involved in supporting implementation of system-wide components (i.e. policy makers, clinical champions, health service managers).

Exclusion Criteria

* Unable to provide informed consent
* Under the age of 16 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact on individual measures of participant metabolic health and wellbeing - HbA1c[HbA1c Baseline, 6 and 12 months (primary timepoint) after baseline assessment];Impact on individual measures of participant metabolic health and wellbeing - urine albumin-creatinine ratio[urine albumin-creatinine ratio Baseline, 6 and 12 months (primary timepoint) after baseline assessment];Impact on individual measures of participant metabolic health and wellbeing - blood lipid profile[Fasting lipid profile Baseline, 6 and 12 months (primary timepoint) after baseline assessment]