Plain English Summary
Background and study aims:
Every day around 84 pregnant women are diagnosed with gestational diabetes in the UK. While every woman with gestational diabetes receives care and treatment from their diabetes care team there are very few resources available to help women understand their diagnosis and inform them how best to manage their diabetes. To address this issue we have developed a DVD called: Gestational Diabetes.... what you need to know (but maybe dont!). This DVD has been designed and produced with continuous input from women with gestational diabetes and health care professionals. We do not know if this DVD will be of any additional benefit to women with gestational diabetes. Therefore the purpose of this study is to find out whether watching this DVD when diagnosed with gestational diabetes will have any effect on the understanding of the condition and how best to manage it, including the effect on blood sugar control or levels of stress and anxiety.
Who can participate?
All women who are aged 16 years or older, who recently have been diagnosed with gestational diabetes for the first time.
What does the study involve?
Participants will be asked to complete questionnaires on three separate occasions. Each visit will take place during routine antenatal clinic visits. The first visit will take place as soon as possible after diagnosis of gestational diabetes. The women will be asked to complete 6 short questionnaires about how they are feeling about their pregnancy and gestational diabetes diagnosis and about their diet. This will take 25 - 30 minutes. Half of the women taking part in the study will be given the DVD to watch at home (46 minutes long), and the other half will not be given the DVD. This is so we can compare the results of the two different groups to see if one is better. The women will be put into a group by chance (randomly), with the decision about which group randomly decided by a computer programme operated by an independent department. All women taking part in the study will receive the same care from their diabetes care team. Women who receive the DVD, will be asked to watch it as soon as you have some free time and will receive a follow-up call or text message to remind them to watch it. The second visit takes place two weeks later during a routine clinic appointment. The women will be asked to complete the same 6 questionnaires which will take 25 - 30 minutes. The third visit will take place about 6-8 weeks after the babys delivery during a routine postnatal visit. The women will be asked to complete 3 questionnaires which will take approximately 20 minutes. As part of usual care, the diabetes care team will ask all women with gestational diabetes to monitor their blood sugar level with a blood glucose meter throughout their pregnancy. The researcher will download the readings from the meter at study visit 2 and at around 36 weeks gestation.
What are the possible benefits and risks of participating?
Taking part in this study may improve the participants knowledge of gestational diabetes and how to manage it. Those who do not receive the DVD as part of this study will receive a copy at the end of the study to keep. The content of the DVD may also be beneficial for after the delivery of the baby, and in any future pregnancies. The main disadvantage of taking part in the study is having to give up some spare time to complete the questionnaires and watch the DVD. However, to reduce this inconvenience we have scheduled the study visits to at the same as routine clinic appointments and questionnaires can be completed over the phone if preferred.
Where is the study run from?
Queens University Belfast in collaboration with The Ulster Hospital, Dundonald, The Royal Group of Hospitals, Belfast and St. Marys Hospital, Manchester.
When is the study starting and how long is it expected to for?
The study is starting in December 2012, and will run for 22 months.
Who is funding the study?
International Diabetes Federation and Lilly Diabetes.
Who is the main contact?
Dr Valerie Holmes
v.holmes@qub.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Valerie Holmes
ORCID ID
Contact details
Queen's University Belfast
Nutrition & Metabolism Research Group
Centre for Public Health
Institute of Clinical Science Block B
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
-
v.holmes@qub.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LT10-346
Study information
Scientific title
Gestational Diabetes: Things you need to know (but maybe don't) - phase II: randomised controlled trial of a DVD for women with Gestational Diabetes Mellitus
Acronym
Study hypothesis
An educational DVD developed in partnership with women with gestational diabetes mellitus (GDM) and healthcare professionals, will reduce maternal anxiety and improve glycaemic control in women diagnosed with GDM, will reduce pregnancy specific stress, increase knowledge and enhance self-efficacy, to impact positively on maternal and neonatal outcomes.
Ethics approval
Office of Research Ethics Committees Northern Ireland (ORECNI), 10/10/2012, ref: 12/NI/0144
Study design
Multi-centre non-blinded randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Gestational Diabetes Mellitus
Intervention
The experimental arm will receive the DVD in addition to standard/usual care.
The control arm will receive standard/usual care alone.
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
1. Maternal anxiety at study visit 2 (2 weeks after randomization)
2. Mean 1 hour post-prandial glucose as part of a 7 point glucose profile in the 24 hour period prior to visit 2 (2 weeks after randomization) as measured by self blood glucose monitoring
Secondary outcome measures
1. Pregnancy specific stress at visit 2
2. Emotional adjustment to diabetes at visit 2
3. Self-efficacy at visit 2
4. Knowledge of gestational diabetes at visit 2 Maternal anxiety at visit 3 (6 weeks post delivery)
5. Risk Perception Survey for Developing Diabetes (RPS-DD) Visit 3
Overall trial start date
01/12/2012
Overall trial end date
01/09/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 16 or older
2. Pregnant women with a recent new diagnosis of GDM (as per IADPSG criteria) eligible if YES to one of the following criteria:
2.1. Fasting plasma glucose, HbA1C, or random plasma glucose at booking:
2.2. Fasting plasma glucose ≥ 5.1 mmol/l (92 mg/dl) but <7.0 mmol/l (126 mg/dl)
3. OGTT after 24 weeks gestation:
3.1. FPG ≥ 5.1 mmol/l (92 mg/dl)
3.2. 1-h plasma glucose ≥ 10.0 mmol/l (180 mg/dl)
3.3. 2-h plasma glucose ≥ 8.5 mmol/l (153 mg/dl)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
150
Participant exclusion criteria
1. Diagnosed with GDM in a previous pregnancy
2. Deemed inappropriate for woman to take part in the RCT by their Consultant Obstetrician / Physician, for example if a poor pregnancy outcome is anticipated.
3. Diagnosed with type 1 or type 2 diabetes during this pregnancy
4.Taking part in another research study
Recruitment start date
01/12/2012
Recruitment end date
01/09/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen's University Belfast
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
Queen's University Belfast (UK)
Sponsor details
Research and Enterprise
63 University Road
Belfast
BT7 1NF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
This project is supported by a BRIDGES Grant from the International Diabetes Federation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
BRIDGES, an International Diabetes Federation project, is supported by an educational grant from Lilly Diabetes. ref: LT10-346
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28258027 (added 22/01/2019)