Plain English Summary
Background and study aims
Women who develop a type of diabetes during pregnancy called gestational diabetes mellitus (GDM) are at higher risk of developing type 2 diabetes (T2DM) in the future compared to women without GDM. There are also at risk of further episodes of GDM in subsequent pregnancies. An estimated 1 in 20 pregnancies in the UK are affected by GDM, and the incidence is increasing. The children of mothers with diabetes in pregnancy are more likely to be obese or develop T2DM. T2DM is associated with long-term complications, but can be delayed or prevented in populations at high risk through lifestyle interventions promoting healthy eating, physical activity or weight loss. An intervention has been developed to help prevent T2DM through healthy eating, physical activity and weight loss in women with GDM. The aim of this study is assess the feasibility of conducting a full scale trial of this intervention.
Who can participate?
Pregnant women aged 18 and over who have recently received a diagnosis of GDM
What does the study involve?
Participants are randomly allocated to receive the intervention plus usual care or to receive usual care only. The intervention consists of five one-to-one motivational interviewing sessions, use of a pedometer, access to an information website and participation in a WhatsApp group. The study is conducted over a 12-month period with data collected at the start and after 6 and 12 months to examine the feasibility of conducting a trial through measuring the number of participants recruited and retained. The acceptability of the trial and the intervention from the participants' and healthcare professionals' perspectives is also assessed. Secondly, a number of other factors are measured in both groups including weight loss, diet, physical activity, blood glucose, depression and diabetes risk perception.
What are the possible benefits and risks of participating?
The results of this feasibility trial will be used to inform the full scale trial, which will test the effectiveness of the intervention. There may be benefits for those participants in the intervention group resulting from the receipt of five extra sessions of one-to-one, individualised care, as well as access to a website providing information, a pedometer and a WhatsApp group. Benefits could include increased understanding of GDM, improved emotional wellbeing, increased social connection, and improved physical health. All participants may benefit from receiving extra blood tests, which will provide the participant with more information on their own health. There are not considered to be any major risks involved in the study. Possible minor risks include added anxiety as a result of the extra blood tests and participants may feel burdened by having to attend more hospital appointments that they otherwise would.
Where is the study run from?
1. King's College Hospital (UK)
2. St Thomas’ Hospital (UK)
When is the study starting and how long is it expected to run for?
August 2017 to May 2020
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Ms Judith Parsons
Judith.parsons@kcl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Ms Judith Parsons
ORCID ID
http://orcid.org/0000-0002-9656-5940
Contact details
Florence Nightingale Faculty of Nursing
Midwifery and Palliative Care
King's College London
Room 4.26
James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
United Kingdom
+44 (0)20 7848 4177
Judith.parsons@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
36423
Study information
Scientific title
The GestatiOnal Diabetes future DiabEteS prevention Study (GODDESS) - feasibility study
Acronym
GODDESS version 1
Study hypothesis
Women who develop a type of diabetes during pregnancy called gestational diabetes mellitus (GDM), are at higher risk of developing type 2 diabetes (T2DM) in the future compared to women without GDM. There are also at risk of further episodes of GDM in subsequent pregnancies. An estimated 1 in 20 pregnancies in the UK are affected by GDM, and the incidence is increasing. The children of mothers with diabetes in pregnancy are more likely to be obese or develop T2DM. T2DM is associated with long-term complications, but can be delayed or prevented in populations at high risk, through lifestyle interventions promoting healthy eating, physical activity or weight loss. The trialists have developed an intervention to help prevent T2DM through healthy eating, physical activity and weight loss in women with GDM, and want to undertake a feasibility study before they conduct a full scale trial of this intervention.
Ethics approval
London - Surrey Borders Research Ethics Committee, provisional favourable ethical opinion 22/05/2018, subject to revising some information on a poster advertising the study, final approval pending, ref: 18/LO/0794
Study design
Randomised; Interventional; Design type: Prevention, Education or Self-Management, Psychological & Behavioural, Complex Intervention
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
Gestational diabetes
Intervention
60 women who have recently received a diagnosis of GDM will be recruited and block randomisation in blocks of 10 will be used to randomly assign 30 women to receive the intervention and 30 to receive usual care. The intervention group will receive five one-to-one motivational interviewing sessions and be supported by use of a pedometer, access to an information website and participation in a WhatsApp group. This will be in addition to usual care. The control group will receive usual care only. The intervention will be conducted over a 12-month period with data collected at baseline, 6 months and 12 months.
The feasibility of conducting a trial will be examined through measuring the number of participants recruited and retained in the study. The acceptability of the trial and intervention from the participants' and healthcare professionals' perspectives will also be assessed. Secondly, a number of other factors will be measured in both groups for indications of preliminary efficacy of the intervention. These include weight loss, diet, physical activity, blood glucose, depression and diabetes risk perception. The results of this feasibility trial will be used to inform the full scale trial to test the effectiveness of the intervention.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
The feasibility of the trial, measured through: acceptability (recruitment, retention, acceptability of intervention and data collection procedures for participants), practicality (fidelity, acceptability for clinic staff and intervention facilitators); Timepoint(s): End of the study
Secondary outcome measures
1. Glucose tolerance is measured using a two hour fasting oral glucose tolerance test (OGTT) at baseline, 6 and 12 months
2. Average plasma glucose concentration is measured using glycated haemoglobin (HbA1c) at baseline, 6 and 12 months
3. Blood pressure is measured using a blood pressure cuff at baseline, 6 and 12 months
4. Weight is measured using digital scales at 6 and 12 months. Baseline weight is taken from pre-existing medical records for weight at pregnancy booking appointment
5. Waist circumference is measured using a tape measure at 6 and 12 months
6. Depression is measured using Patient Health Questionnaire (PHQ) 9 at baseline, 6 and 12 months
7. Postnatal depression is measured using the Edinburgh Postnatal Depression Scale at baseline, 6 and 12 months
8. Quality of life is measured using EuroQol EQ-5D-5L at baseline, 6 and 12 months
9. Body image is measured using the Body Appreciation Scale (BAS) at baseline, 6 months and 12 months
10. Eating behaviour is measured using an adapted version of the Three Factor Eating Questionnaire at baseline, 6 months and 12 months
11. Motivation to change is measured using the Dietary Change Motivation Scale at baseline, 6 and 12 months
12. Diabetes risk perception is measured using the Risk Perception Survey for Developing Diabetes at baseline, 6 and 12 months
13. Dietary intake is measured using the Multiple Pass 24 hour Diet Recall online questionnaire (INTAKE) at baseline, 6 and 12 months
14. Physical activity is measured using an adapted version of the Global Physical Activity Questionnaire (GPAQ) and 4 day accelerometer at baseline, 6 and 12 months
15. Sleep is measured using 6 questions on sleep at baseline, 6 and 12 months
16. Infant feeding intentions are measured using the Infant Feeding Intentions Scale at baseline
17. Infant feeding is measured using 3 questions at 6 and 12 months
Overall trial start date
01/08/2017
Overall trial end date
31/05/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged ≥18 years
2. Diagnosed with GDM (NICE criteria)
3. ≤30 weeks pregnant
4. Able to speak and understand English
5. Access to the internet
6. Body mass index (BMI) of ≥ 25 kg/m2 (or ≥22 kg/m2 if Asian)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 60; UK Sample Size: 60
Total final enrolment
60
Participant exclusion criteria
1. Unable to consent
2. Under 18 years
3. ≥31 weeks pregnant
4. BMI <24, or <22 in Asian ethnic groups
5. Unable to speak and understand English
6. Serious mental illness
7. No access to the internet
Recruitment start date
16/07/2018
Recruitment end date
08/05/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College Hospital (lead centre)
Denmark Hill
London
SE5 9RS
United Kingdom
Trial participating centre
St Thomas’ Hospital
Westminster Bridge Rd
Lambeth
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
King's College London
Sponsor details
c/o Mr Reza Razavi
Room 1.8 Hodgkin Building
Guy’s Campus
London
SE1 1UL
United Kingdom
+44 (0)20 7847 6960
reza.razavi@kcl.qc.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR Trainees Co-ordinating Centre (TCC); Grant Codes: DRF-2013-06-054
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal intended for May 2021.
Presentation at national and international conferences intended during 2020.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Judith Parsons (judith.parsons@kcl.ac.uk). The data will be available on request for 5 years after the end date of the study. The researchers will permit access to researchers in recognised academic institutions upon receipt of an explanation for the rationale for accessing the data, its intended use, and an agreement to acknowledge the source of the data. They will provide anonymised data in an Excel spreadsheet. Consent was taken from participants to share anonymous data with other researchers.
Intention to publish date
01/05/2021
Participant level data
Available on request
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN52675820_PIS_v4_28Feb18.docx Uploaded 13/06/2018
- ISRCTN52675820_PROTOCOL_v5_28Feb18.docx Uploaded 13/06/2018