Condition category
Pregnancy and Childbirth
Date applied
29/10/2014
Date assigned
29/10/2014
Last edited
18/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

18/02/2016: Publication reference added.