Condition category
Pregnancy and Childbirth
Date applied
11/12/2012
Date assigned
21/01/2013
Last edited
08/12/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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. Approximately 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.

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.

Who is the main contact?
Professor Fionnuala McAuliffe PI
fionnuala.mcauliffe@ucd.ie

Trial website

Contact information

Type

Scientific

Primary contact

Prof Fionnuala McAuliffe

ORCID ID

Contact details

National Maternity Hospital
Holles St
Dublin
-
Ireland
+353 1 6373216
fionnuala.mcauliffe@ucd.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Pregnancy, Exercise And nutrition Research study with app support: A randomized controlled trial

Acronym

PEARs

Study hypothesis

We hypothesize that 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

National Maternity Hospital, Holles’ St, Dublin 2, 15/10/2012

Study design

Single centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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 smart phone 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

Phase

Not Applicable

Drug names

Primary outcome measures

Difference between the intervention and control groups at 29 weeks in the incidence of Gestational Diabetes according to the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) criteria.

Secondary outcome measures

1. Gestational weight gain
2. Maternal Glycemic Index (GI) value
3. Maternal activity levels in the 3rd trimester

Overall trial start date

07/01/2013

Overall trial end date

30/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Singleton pregnancies with a live fetus
2. Smart phone
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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

500 pregnant women in total with a BMI > 25, 250 in intervention arm and 250 in control arm

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

Trial participating centre

National Maternity Hospital
Dublin
-
Ireland

Sponsor information

Organisation

National Maternity Hospital (Ireland)

Sponsor details

Holles St
Dublin
-
Ireland
+353 1 6373216
fionnuala.mcauliffe@ucd.ie

Sponsor type

Hospital/treatment centre

Website

http://www.nmh.ie

Funders

Funder type

Hospital/treatment centre

Funder name

National Maternity Hospital (Ireland) - Medical Fund

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.