Gestational diabetes mellitus Pregnancy and Childbirth Diabetes mellitus in pregnancy, unspecified
Conditions
Interventions
The control group will receive usual health care, which includes written information on diet and lifestyle changes recommended for reducing the risk of developing type 2 diabetes and visits with gener
Sponsors
Health Research Board (Ireland)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women of child-bearing age with a history of gestational diabetes mellitus. At recruitment, participants must also have the following risk factors for diabetes: either: 1. Impaired fasting glucose (FPG>5.67.8 130/80 mmHg 2.2. Total cholesterol > 4.5 mmol/l 2.3. Low density lipoprotein (LDL) cholesterol > 2.5 mmol/l 2.4. Triglycerides >1.69mmol/L 2.5. High density lipoprotein (HDL) cholesterol 30 2.7. Waist circumference > 88 cm
Exclusion criteria
Exclusion criteria: 1. Individuals with significant cognitive impairments or mental illness 2. Individuals with inadequate English language ability to understand the content of the intervention programme 3. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose dysfunction, measured as mean reduction from baseline to 1-year follow-up by a Fasting Plasma Glucose (FPG) test and 2-hour postprandial (PP) glucose levels on a 75 g Oral Glucose Tolerance Test (OGTT). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Insulin resistance - decrease measured by HOMA analysis on insulin and glucose values on a 75 g OGTT 2. Diet adherence - measured as a combination of: 2.1. Mean improvement on the MedDietScore 2.2. Proportions achieving target fruit and vegetable consumption of >400 g/day; and 2.3. Proportions achieving oily fish intake of > once per week 3. Weight and shape - measured as: 3.1. Mean weight reduction (kg) in individuals with a Body Mass Index (BMI) of >30 kg/m2 at baseline; and 3.2. Mean reduction in waist circumference in individuals with >88 cm at baseline 4. Physical activity - measured as change in functional capacity on objective physical fitness test: Chester Step Test (CST) or 6-minute walk test 5. Lipid profile - measured as a combination of: 5.1. Proportions achieving a lipid target of total cholesterol 1.29 mmol/L; and 5.2. Mean reduction in total and LDL-cholesterol 6. Positive mental health - measured on 9-items related to energy and vitality during the past month, and non-specific psychological distress (from SLÁN, the National Survey of Health and Lifestyles in Ireland, 2007) 7. General health - measured on 1-item from SLÁN, the National Survey of Health and Lifestyles in Ireland, 2007 8. Quality of life - measured on 1-item from SLÁN, the National Survey of Health and Lifestyles in Ireland, 2007 9. Motivation to change - measured on 1-item assessing preparedness and motivation to change health-related behaviours (from the Stages of Change Model by Prochaska, DiClemente and Norcross, 1992) 10. Perceived social support - measured on 2-items from Moore et al.?s research on lifestyle intervention for type 2 diabetes (2007, 2009, 2011) 11. Diabetes-related self-efficacy - measured on a 2-part exercise on confidence to engage in exercise and healthy eating under different ?barrier? conditions (from Stanford University Patient Education Research Centre Self-efficacy for Diabetes Scale and Diabetes Empowerment Scale - Anderson, Funnell, Fitzgerald, & | — |
Countries
Ireland
Outcome results
None listed