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Baby Steps - Walking Away from Gestational Diabetes

A randomised controlled trial to investigate the effect of a structured education programme on women who have had gestational diabetes and are at risk of developing type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17299860
Enrollment
290
Registered
2017-04-05
Start date
2017-05-01
Completion date
Unknown
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Reproductive health and childbirth, Primary sub-specialty: Maternal/ Fetal medicine

Interventions

An invitation pack (letter, short information leaflet and prepaid envelope) will be sent to patients identified as eligible on a register maintained by the maternity department. Expressions of interes
=30) and ethnicity (White European
other) and will dictate the pathway each participant will take in the study (control group or intervention group). The stratified randomisation lists will be prepared by an independent statistician, f

Sponsors

University of Leicester
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. A diagnosis of gestational diabetes in most recent pregnancy 2. Up to 36 months postnatal 3. Willing and able to attend the education sessions and clinic 4. Willing and able to give informed consent 5. Able to speak and read English to a sufficient level to understand the study and education programme 6. Telephone access 7. Aged 18 years and older

Exclusion criteria

Exclusion criteria: 1. Currently has gestational diabetes 2. Currently pregnant at present 3. Type 1 or type 2 diabetes 4. Cancer (not in remission) 5. Severe diagnosed mental illness (e.g. Schizophrenia, bipolar) 6. Previous surgical or medical intervention to treat obesity 7. No access to internet 8. Does not have capacity to give informed consent 9. Participants who are currently participating or who have participated in another clinical intervention study in the previous 12 weeks 10. Unable to speak and read English to a sufficient level to understand the study and education programme

Design outcomes

Primary

MeasureTime frame
Physical activity is measured using an accelerometer, worn for 8 days at baseline, 6 months and 12 months.

Secondary

MeasureTime frame
1. Lipid profile (high density lipoproteins, low density lipoproteins, triglycerides, total cholesterol) is measured using a venous blood sample at baseline and 12 months 2. Glycated haemoglobin (HbA1c) is measured is measured using a venous blood sample at baseline and 12 months 3. Resting heart rate and blood pressure are measured using an automated BP device at baseline and 12 months 4. Body mass, BMI, waist circumference and hip circumference are measured using a height scale, weight scales, and tape measure at baseline and 12 months 5. Self-reported physical activity is measured using the validated Recent Physical Activity Questionnaire (RPAQ) at baseline, 6 and 12 months 6. Health related quality of Life is measured using the EQ-5D-5L questionnaire at baseline, 6 and 12 months 7. Anxiety and Depression is measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 6 and 12 months 8. Exercise self efficacy is measured using the Jenkins Self-Efficacy for Exercise Expectations Scale at baseline, 6 and 12 months 9. Fruit and vegetable intake is measured using the 5-A-Day Consumption and Evaluation Tool (FACET) at baseline, 6 and 12 months

Countries

England, United Kingdom

Contacts

Public ContactHelen Dallosso
helen.dalloss@uhl-tr.nhs.uk+44 (0)116 2584738

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026