Investigation into the effect of intensive dietary intervention on post prandial glycaemic control and perception of risk of developing diabetes in women with a history of gestational diabetes
| ISRCTN | ISRCTN81663155 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81663155 |
| Protocol serial number | N0016132018 |
| Sponsor | Department of Health |
| Funder | Hammersmith Hospital NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 02/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Linda Carter
Scientific
Scientific
Diabetes and Endocrinology
Nutrition & Dietetics
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
| Phone | +44 (0)20 8846 1445 |
|---|---|
| Lcarter@hhnt.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Investigation into the effect of intensive dietary intervention on post prandial glycaemic control and perception of risk of developing diabetes in women with a history of gestational diabetes |
| Study objectives | 1. To examine the effects of an intensive dietary intervention on post prandial blood glucose profiles (and first phase insulin response). 2. To examine the effects of that dietary education programme on perception of risk and ability to influence the risk of developing diabetes for women with a history of gestational diabetes. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Nutritional, Metabolic, Endocrine: Diabetes |
| Intervention | Randomised controlled trial of a dietary education programme. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
The intervention aims to improve post prandial glycaemic control and insulin response hence reducing the risk or delaying the onset of Type 2 diabetes. The study will investigate whether the risk of developing Type 2 diabetes can be reduced by using intensive dietetic strategy, originally developed as an intensive weight management service within the diabetes framework. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 27/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Female |
| Key inclusion criteria | Females aged 18-50 years |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 28/08/2003 |
| Date of final enrolment | 27/08/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Charing Cross Hospital
London
W6 8RF
United Kingdom
W6 8RF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/11/2016: No publications found, verifying study status with principal investigator.