Diabetes Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
A trial feasibility study will be undertaken in Karachi, Pakistan that will establish acceptability and feasibility of the intervention to provide a tailored physical activity and diet programme to re
Sponsors
Medical Research Council
Wellcome Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with a history of GDM 2. Delivered at any two of the site hospitals 3. Tested negative on postnatal OGTT at 6 weeks
Exclusion criteria
Exclusion criteria: Women who are not resident of Karachi or will be migrating out of Karachi within 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in body weight by 5%; weight was measured at baseline, 6 months and 12 months. Body composition analyzer was used to undertake anthropometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Feasibility of sampling strategy, assessed at the time of analysis 2. Proportion of eligible people recruited, assessed at the time of analysis 3. Adherence to the intervention, assessed at the time of analysis 4. Response to randomization, assessed at the time of analysis 5. Contamination: the proportion of participants who increase their physical activity in the usual care arm. Physical activity was measured by Short International Physical Activity Questionnaire at 6 and 12 months 6. Follow-up rate at 6 and 12 months 7. Response at 12 months to Oral Glucose Tolerance Test – this outcome was kept to assess the feasibility of doing OGTT at a woman’s home but at the initial phase of the study it was not found to be feasible and NICE guidelines (https://www.nice.org.uk/news/article/new-thresholds-for-diagnosis-of-diabetes-in-pregnancy) also recommend to do fasting blood sugar levels or OGTT to screen for diabetes. Hence the trialists changed their strategy and did FBS on the majority of patients. 8. Duration of moderate or vigorous activity at 12 months follow-up. Physical activity was measured by Short International Physical Activity Questionnaire at 6 months and 12 months 9. Response and completion of the self-reported physical activity (7 day physical activity recall) assessed at the time of analysis 10. Response and completion of abbreviated food frequency questionnaire to estimate frequency of key foods, such as fruit and vegetables – food intake is measured by Food Frequency Questionnaire at 6 months and 12 months 11. Response to blood sampling to measure HbA1c and fasting lipids (LDL, HDL, triglycerides) at baseline and at 12 months. Venous blood samples were collected during fasting at baseline, 6 months and 12 months 12. Blood pressure, BMI, % body fat, waist circumference. Blood pressures are measured by Omron digital blood pressure apparatus at baseline, 6 and 12 months. Rest of the measurements were taken by Tanita body composition analy | — |
Countries
Pakistan
Contacts
Public ContactRomaina Iqbal
Outcome results
None listed