Pregnancy, Exercise And nutrition Research study with app support
| ISRCTN | ISRCTN29316280 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29316280 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/12/2012
- Registration date
- 21/01/2013
- Last edited
- 13/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
Overweight, body mass index (BMI) ≥ 24.9 kg/m2 and obesity (BMI ≥ 30 kg/m2) carry a huge health burden both on the individual and on society. About 5 out of 10 women of reproductive age are either overweight or obese and this increases the risk of adverse pregnancy and fetal outcomes. For the mother, there is a higher incidence of pre- eclampsia, gestational diabetes and operative intervention at the time of delivery such as caesarean section and instrumental delivery. Problems that can arise in the baby include macrosomia [newborn with an excessive birth weight (baby > 4kg at birth)], shoulder dystocia [occurs when the baby's head has been born but one of the shoulders becomes stuck behind the mother's pelvic bone], birth injury and admission to the special care baby unit. These adverse outcomes correlate with increasing BMI, increasing gestational weight gain, higher maternal blood glucose levels and gestational diabetes. This study will examine the effect of a "healthy lifestyle package with app support" compared with routine pregnancy care on pregnancy outcomes. The "healthy lifestyle package with app support" includes a combination of a healthy diet, an exercise intervention with a smart phone application as an information and motivational source for overweight and obese women in pregnancy. The primary aim is to assess the impact of the "healthy lifestyle package with app support" on development of gestational diabetes when compared to routine antenatal care.
Who can participate?
Women with singleton pregnancies between 10-15 weeks gestation between the ages of 18-45 with a smartphone, and a BMI of greater than 25 kg/m2
What does the study involve?
Women will be randomly assigned into two groups: an intervention group and a control group. Women in the intervention group will have standard antenatal care but will receive a particular healthy lifestyle package with app support. This package includes a combination of a healthy diet, an exercise intervention with a smart phone application as an information and motivational source for overweight and obese women in pregnancy. The control group will receive a 'regular lifestyle package', which will consist of standard antenatal care and general advice on weight gain according to BMI.
What are the possible benefits and risks of participating?
The benefits for participating are numerous. These include lower glucose levels and less gestational weight gain. The study aims to motivate and change behaviors in order to lead a healthier lifestyle, which will reduce the risk of obstetric and fetal complications as mentioned above and improve long-term health. There will also be an additional scan of the baby to assess growth at 34 weeks. Studies have shown that there are absolutely no risks to the mother or her baby from taking part in a healthy diet and sensible exercise plan during pregnancy.
Where is the study run from?
The study will run from the National Maternity Hospital (Ireland)
When is the study starting and how long is it expected to run for?
The trial is starting in January 2013 and is expected to run for 2 years.
Who is funding the study?
National Maternity Hospital medical fund (Ireland)
Who is the main contact?
Prof. Fionnuala McAuliffe PI
fionnuala.mcauliffe@ucd.ie
Contact information
Scientific
National Maternity Hospital
Holles St
Dublin
-
Ireland
| Phone | +353 (0)1 6373216 |
|---|---|
| fionnuala.mcauliffe@ucd.ie |
Study information
| Study design | Single-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Pregnancy, Exercise And nutrition Research study with app support: A randomized controlled trial |
| Study acronym | PEARs |
| Study hypothesis | The introduction of a 'healthy lifestyle package with app support for overweight and obese women in pregnancy could reduce the incidence of gestational diabetes. |
| Ethics approval(s) | National Maternity Hospital, Holles St, Dublin 2, 15/10/2012 |
| Condition | Pregnancy/overweight/obesity/gestational diabetes |
| Intervention | 1. Recruitment according to above criteria 2. Written and informed consent 3. Randomization will occur into the intervention and control groups. The intervention group will receive a "Healthy lifestyle package" which consists of targeted advice on a low GI eucaloric diet, individualized exercise goals and a specially designed smartphone application containing daily information about nutrition, and exercise delivered in a motivational way. The control group will receive usual care or "regular lifestyle group". At randomization: 1. Maternal anthropometry 2. 3-day food diary, International Physical Activity Questionnaire (IPAQ) and stages of change questionnaire 3. Fasting glucose 4. Intervention group- individual and group education sessions on the healthy lifestyle package as outlined above 5. Control group will receive routine antenatal care which does not include specific nutritional advice nor specific advice on gestational weight gain 24 weeks 6. Research team to be in contact with the intervention group every 2 weeks to support adherence to exercise goals and low GI diet. 28 weeks: 1. Maternal weight recorded 2. Glucose Tolerance Test (GTT) 3. IPAQ, stages of change questionnaire 4. 3 day food diary 34 weeks: 1. Maternal weight recorded 2. Ultrasound for fetal growth 3. 3 day food diary, compliance questionnaire, IPAQ, stages of change questionnaire Delivery: 1. Cord bloods for glucose 2. Birthweight, Ponderal Index (PI) |
| Intervention type | Other |
| Primary outcome measure | incidence of gestational diabetes according to the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) criteria at 29 weeks |
| Secondary outcome measures | 1. Gestational weight gain 2. Maternal Glycemic Index (GI) value 3. Maternal activity levels in the 3rd trimester |
| Overall study start date | 07/01/2013 |
| Overall study end date | 30/08/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 500 pregnant women in total with a BMI > 25, 250 in intervention arm and 250 in control arm |
| Participant inclusion criteria | 1. Singleton pregnancies with a live fetus 2. Smartphone 3. Women between the ages of 18 and 45 at 10-15 weeks gestation with an early pregnancy body mass index (BMI) ≥ 25 kg/m2 4. Women with adequate understanding of the English language and an understanding of the study to enable them to give informed consent to participate |
| Participant exclusion criteria | 1. Multiple Pregnancy 2. Women < 18 or >45 years of age 3. Those with pre gestational diabetes or early onset gestational diabetes mellitus or past history of gestational diabetes 4. Fetal anomaly 5. Previous stillbirth/perinatal death 6. Those whose English is inadequate or those who are unable to understand the study adequately to participate 7. Those with a medical disorder requiring medication |
| Recruitment start date | 01/03/2013 |
| Recruitment end date | 30/01/2016 |
Locations
Countries of recruitment
- Ireland
Study participating centre
-
Ireland
Sponsor information
Hospital/treatment centre
Holles St
Dublin
-
Ireland
| Phone | +353 (0)1 6373216 |
|---|---|
| fionnuala.mcauliffe@ucd.ie | |
| Website | http://www.nmh.ie |
"ROR" |
https://ror.org/03jcxa214 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2018 | Yes | No | |
| Results article | secondary analysis results | 12/05/2021 | 13/05/2021 | Yes | No |
Editorial Notes
13/05/2021: Publication reference added.
11/04/2018: Publication reference added.
07/12/2016: The overall trial end date has been updated from the anticipated end date of 30/01/2016 to actual end of date of 30/08/2016 and the anticipated start date of 07/01/2013 has been updated to actual recruitment start date of 01/03/2013.
