Contact information
Type
Scientific
Primary contact
Mrs Sue Clifford
ORCID ID
Contact details
Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
S.Clifford@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17504
Study information
Scientific title
Effectiveness of regular weighing and feedback by community midwives in preventing excessive gestational weight gain: a randomised controlled trial (POPS 2)
Acronym
POPS2
Study hypothesis
During pregnancy many women gain too much weight because they do less physical activity and eat more food. This can lead to complications for the mother during pregnancy and it can also negatively affect the health of the baby. Weight gained during pregnancy which is not lost afterwards could lead to women becoming obese or starting subsequent pregnancies in an unhealthy weight state. There is a need therefore to evaluate interventions to prevent women gaining excessive weight during pregnancy. The ideal health professionals to help women do this are community midwives since they see women regularly throughout pregnancy and their role is to promote good outcomes for mother and baby. 490 women who are having a pregnancy without complications being cared for by community midwives will be eligible. Women will be randomised to receive usual care from their midwife or usual care plus the intervention. The intervention is led by community midwives who will regularly weigh pregnant women at routine antenatal visits, plot their weight on a weight gain chart, set parameters for healthy weight gain for each subsequent appointment, provide feedback on weight gain progress and encourage women to weigh themselves each week. Brief messages about the importance of eating healthily and physical activity during pregnancy Regular weighing of pregnant women by community midwives is not currently recommended in the UK. However our feasibility study has shown this type of intervention to be promising in preventing excessive weight gain during pregnancy and it does not cause women to become anxious. Weight will be measured at 10-14 weeks and 38 weeks of pregnancy to determine if they have gained excess weight. We also plan to interview up to 30 women and 30 community midwives about their experiences of participating in the study.
Ethics approval
14/WM/1134; First MREC approval date 02/10/2014
Study design
Randomised; Interventional; Design type: Process of Care
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Topic: Primary Care, Reproductive health and childbirth; Subtopic: Reproductive Health and Childb (all Subtopics), Reproductive health and childbirth; Disease: Reproductive Health & Childbirth, All Diseases
Intervention
Women will be randomised to receive usual care from their midwife or usual care plus the intervention.
Intervention:
1. Self-monitoring -The intervention will actively engage women in self monitoring by recording their weekly weight on a record chart.
2. Weighing - Community midwives will weigh women at each antenatal appointment and plot their weight on an IOM weight gain chart, appropriate to their BMI, set a maximum weight gain limit for each subsequent appointment, and give brief feedback on their progress emphasising the importance of healthy weight gain.
Follow Up Length: 7 month(s)
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
Proportion who exceed IOM guidelines for pregnancy weight gain. Timepoint(s): 38 weeks of pregnancy
Secondary outcome measures
1. Difference in change in weight from baseline to 38 weeks of pregnancy between groups.Timepoint(s): 38 weeks of pregnancy
2. Difference in change in weight gain per week of pregnancy between groups.Timepoint(s): 38 weeks of pregnancy.
3. Differences in changes in psychological health, QoL, physical activity and diet quality. Timepoint(s): 38 weeks of pregnancy
4. Maternal and neonatal complications. Timepoint(s): After birth of baby
Overall trial start date
01/11/2014
Overall trial end date
30/08/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged at least 18 years
2. Between 10+0 and 14+6 weeks of pregnancy.
3. Low risk singleton pregnancy.
4. BMI =18.5 kg/m2 receiving community midwife led care
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 490; UK Sample Size: 490; Description: SS incorporates 20% loss to follow up.
Participant exclusion criteria
1. Obese women receiving consultant led care.
2. Unable to understand English or provide informed consent.
3. Women who are attending a weight management programme (i.e. Slimming World) whilst pregnant.
4. Current severe mental illness, known history of eating disorders or dependent on illicit drugs or alcohol.
Recruitment start date
01/11/2014
Recruitment end date
30/08/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom
Funders
Funder type
Other
Funder name
NIHR CLAHRC-Oxford; NIHR CLAHRC-West Midlands; NIHR School for Primary Care Research
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
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26885375