WEight Loss Looking for Baby And mum's BEtter outcomes (WELLBABE)

Completed

Conditions: Gestational diabetes: hyperglycaemia that is first recognised in pregnancy
Pregnancy and Childbirth
Diabetes mellitus arising in pregnancy

Registration Number: ISRCTN17505466

Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 16

Inclusion Criteria

1. Female
2. Greater than 20 weeks pregnant
3. Gestational diabetes (oral glucose tolerance test greater than/equal to 5.1 mmol/l, or 2-hour glucose greater than/equal to 7.8 mmol/l)

Exclusion Criteria

Contraindication to MRI:
1. Pacemaker/ferromagnetic implants
2. Metallic fragments in eye
3. Piercings that cannot be removed
4. Claustrophobia

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Liver fat – measured at baseline and after 4 weeks of dietary intervention by magnetic resonance spectroscopy<br>2. Glycaemic control – measured by home blood glucose monitoring in the first and fourth weeks

Secondary Outcome Measures

Name	Time	Method
1. Insulin/C peptide/glucose response to a standardised meal test. Measured at baseline and after 4 weeks of dietary intervention<br>2. Lipid profile – measured using nuclear magnetic spectroscopy at baseline and 4 weeks of dietary intervention<br>3. HBA1c – measured at baseline and after 4 weeks of dietary intervention<br>4. Feasibility and acceptibility of dietary intervention in pregnancy (qualitative study) – assessed by semi-structured interview after the dietary intervention and analysed using the theory domain framework<br>