GIFTS: Mother and Child Health Study
| ISRCTN | ISRCTN83599025 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83599025 |
| Protocol serial number | Version 3.1, dated 03/07/2015 |
| Sponsor | Queen Mary University (UK) |
| Funders | European Commission (FP7) (Belgium), BADAS (Diabetic Association of Bangladesh) (Bangladesh) |
- Submission date
- 14/07/2014
- Registration date
- 30/07/2014
- Last edited
- 01/06/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Diabetes and obesity are caused by many different factors. Family history is an important one but the rapid increase in the number of people with these disorders is largely due to lifestyle choices and how our bodies adapt to a changing environment. The epicentre of the diabetes epidemic is in South Asia, with India having the largest number of diabetics in the world. Importantly, similar increases in diabetes are seen in South Asian communities living in Europe; the number of South Asians in Europe with diabetes is 3-6 times higher than the European average. Current diabetes/obesity prevention strategies focus on adult life and target eating habits (and overeating in particular) with treatments designed to reduce the number of high-risk adults actually becoming obese. However, these strategies dont take into account a number of reasons as to why diabetes and obesity are increasing among the South Asian population. Many South Asian people, for example, experience a lack of food leading to inadequate nutrition and energy when living in their home countries, but then after moving to Europe find themselves eating more food and therefore more than the required amount of nutrition and energy needed. This can can lead to a nutritional imbalance over their life-course. This is particularly important during the early stages of pregnancy when the babies are still developing and the surrounding environment may affect the childs genetic predisposition to develop metabolic disease, such as diabetes, in later life. Women from some South Asian groups are less likely to plan a pregnancy before it happens, or take folic acid supplements in pregnancy. They are also less likely to breastfeed and more likely to feed their babies solid food earlier than is recommended. This increases the risk of rapid postnatal (just after birth) growth which may lead to childhood obesity. At present, there is no clear guidance available on how to achieve optimal conditions (the mothers weight and nutrition for example) during this reproductive and early childhood period. The aim of this study is to find out whether the health of women and babies can be improved with a complex treatment program during pregnancy, including supplementation of vitamins and minerals, diet, lifestyle and weight management advice compared with a control group which will be treated as per standard care in Dhaka.
Who can participate?
Women is the first trimester of pregnancy, aged 18-28 years old, have had a maximum of 2 previous pregnancies and are expecting a single baby.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in the control group are offered the usual nutritional and lifestyle care. Those in the intervention (treatment) group receive a number of dietary supplements (vitamins D and B12 and iron) and lifestyle advice. All participants are asked to attend antenatal clinics to donate blood samples and give body measurements. They also complete questionnaires on diet, health and their economic situation. At delivery, samples of blood are taken from the babies umbilical cord and placenta and their body measurements taken.
What are the possible benefits and risks of participating?
Participants are reimbursed for reasonable travel costs and are provided with free antenatal, natal and postnatal care. There is a very low risk of bruising or infection associated with the taking of blood samples. Potential side effects of vitamin B12 and vitamin D is fully explained to all participants and they are closely monitored throughout the study.
Where is the study run from?
The Blizard Institute, Queen Mary, university of London (UK)
When is the study starting and how long is it expected to run for?
June 2014 to June 2015
Who is funding the study?
The European Commission (Belgium) and BADAS (Diabetic Association of Bangladesh) (Bangladesh)
Who is the main contact?
Miss Virginia Govoni
v.govoni@qmul.ac.uk
Contact information
Scientific
Blizard Instititue
Barts and the London School of Medicine and Dentistry
Queen Mary University of London
London
E1 2AT
United Kingdom
| Phone | +44 (0)20 7377 7111 |
|---|---|
| g.a.hitman@qmul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized open-label trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | GIFTS Work Package 3: Pilot intervention in pregnant women in Bangladesh to observe the effect of lifestyle and nutritional intervention in pregnancy and foetal outcomes relevant to metabolic diseases |
| Study acronym | GIFTS WP3 |
| Study objectives | A complex intervention during pregnancy in South Asians involving personalized micronutrient supplementation and lifestyle advice tailored on the nutritional status of the participant will have a positive effect on foetal outcome. |
| Ethics approval(s) | Regional Committee for Medical Research Ethics of Southern Norway, Section D, 13/09/2013, ref. 2013/845/REK sør-øst D and Ethics Committee at Diabetics Association of Bangladesh, 07/05/2011 |
| Health condition(s) or problem(s) studied | Diabetes, obesity, pregnancy |
| Intervention | Control Arm 1 - Usual Care: 1. Subjects: With nutritional deficiencies 2. Randomized 3. Vitamin D: as per obstetricians standard care; vitamin D is not usually measured 4. Vitamin B12: as per obstetricians standard care; vitamin B12 is not usually measured 5. Folate/iron: supplementation (400 mcg/day) throughout pregnancy and iron capsules from 2nd trimester as per obstetricians standard care 6. Lifestyle: as per obstetricians standard care Control Arm 2 1. Subjects: Without nutritional deficiencies 2. Not randomized 3. Vitamin D: as per obstetricians standard care; vitamin D is not usually measured 4. Vitamin B12: as per obstetricians standard care; vitamin B12 is not usually measured 5. Folate/iron: supplementation (400 mcg/day) throughout pregnancy and iron capsules from 2nd trimester as per obstetricians standard care 6. Lifestyle: as per obstetricians standard care Intervention Arm Complex Care: 1. Subjects: With nutritional deficiencies 2. Randomized 3. Vitamin D3: oral (daily dose) <30 nmol/L 4000 IU/day ≥30 nmol/L and <75 nmol/L 2000 IU/day 4. Vitamin B12: level of <200 pg/ml give B12 250 mcg parentally every 25 days 5. Folate/iron: supplementation (400 mcg/day) throughout pregnancy and iron capsules from 2nd trimester as per obstetricians standard care 6. Lifestyle: intervention based on successful intervention developed in the same community with attention to diet and lifestyle The study will be a prospective intervention that will take place in Azimpur near Dhaka, Bangladesh. The study population will reflect a range of targeted lifestyle and nutritional interventions that will provide pilot data to enable development of tailored educational strategies in future large-scale study of South Asian people living in Europe and South Asia informed by the results of the GIFTS program. This study is not designed to test any one intervention alone (i.e. lifestyle, B12 or vitamin D supplementation) but to test the combined intervention depending on the nutritional status of the participant. Added 17/08/2015: Randomized subjects with nutritional deficiencies added to control arm 1 and to intervention arm. Second control arm added for non-randomized subjects without nutritional deficiencies. Added 05/11/2014: We have changed the form of Vitamin B we are administering from injections to tablets, these are called B126TM and contain Thiamine Nitrate (Vit-B1) 100 mg, Pyridoxine Hydrochloride (VIt-B6) 200 mg and Cyanocobalamin (Vit-B12) 200 mcg. Tablets will be taken one every 14 days to reach a daily dosage of Vitamin B12 of =14mcg |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Will be a composite based on maternal micronutrients at term by increasing total vitamin D repletion (>80 nmol/l) to 40% (compared to an estimated 10% repletion in the usual care) and decreasing vitamin B12 deficiency (<200 pg/ml) to 5% (compared to an estimated 15% in usual care) |
| Key secondary outcome measure(s) |
Fetal (taken at delivery): |
| Completion date | 01/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 1200 |
| Key inclusion criteria | 1. Women in the 1st trimester of pregnancy 2. Age between 18 to 28 years 3. Primigravida/multigravida (maximum two previous deliveries) 4. Conception without treatment of infertility 5. Planned hospital delivery 6. Able to provide informed consent for participation in the trial 7. Singleton pregnancy 8. From middle and low socioeconomic background (less than 10,000 Taka – US $ 150, monthly household income) 9. Presenting to antenatal clinics, in 10 locations in Azimpur near Dhaka, Bangladesh Added 17/08/2015: Participant criteria added (points 8 and 9) |
| Key exclusion criteria | 1. Pre-pregnancy diabetes (previously diagnosed or by OGTT at 12-14 weeks gestation 2. History congenital malformations 3. Planned home delivery 4. Multiple pregnancies 5. Known intolerance to any of the micronutrient supplements being administered in the trial 6. Prior history of hypercalcaemia or renal stones 7. Serum calcium >2.65 mmol/L 8. Participation in another trial/study likely to impact the results of this study 9. CKD stage 4 or worse defined by eGFR <30 mL/min/1.73m2 10. History of significant liver disease AST > 3xULN or bilirubin >2.5xULN 11. Active sarcoidosis, tuberculosis or malignancy 12. Thyroid disease 13. Medication: use of multivitamin supplements, thiazide diuretics or oral corticosteroids in the past one month |
| Date of first enrolment | 21/06/2014 |
| Date of final enrolment | 21/06/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
- Bangladesh
Study participating centre
E1 2AT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/04/2018 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/06/2018: Publication reference added.
17/08/2015: The overall study end date was extended to 01/08/2015, and Ethics Committee at Diabetics Association of Bangladesh added to ethics approval.
05/11/2014: The target number of participants was changed from 'Between 1000 to 1200 pregnant women' to 'Between 744 and 1200 pregnant women'.
