Condition category
Pregnancy and Childbirth
Date applied
30/05/2018
Date assigned
13/06/2018
Last edited
13/06/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Specialty: Diabetes, Primary sub-specialty: Other; UKCRC code/ Disease: Metabolic and Endocrine/ Diabetes mellitus, Reproductive health and childbirth/ Other maternal disorders predominantly related to pregnancy

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

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

15/01/2019

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 data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/05/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/06/2018: Uploaded protocol Version 5, 28 February 2018 (not peer-reviewed).