Effectiveness of regular weighing and feedback by community midwives in preventing excessive gestational weight gain

ISRCTN	ISRCTN67427351
DOI	https://doi.org/10.1186/ISRCTN67427351
Secondary identifying numbers	17504

Submission date: 29/10/2014
Registration date: 29/10/2014
Last edited: 15/10/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Sue Clifford
Scientific

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

Email	S.Clifford@bham.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Process of Care
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	Effectiveness of regular weighing and feedback by community midwives in preventing excessive gestational weight gain: a randomised controlled trial (POPS 2)
Study acronym	POPS2
Study objectives	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(s)	14/WM/1134; First MREC approval date 02/10/2014
Health condition(s) or problem(s) studied	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	Behavioural
Primary outcome measure	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 study start date	01/11/2014
Completion date	30/08/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Planned Sample Size: 490; UK Sample Size: 490; Description: SS incorporates 20% loss to follow up.
Total final enrolment	656
Key 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
Key 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.
Date of first enrolment	01/11/2014
Date of final enrolment	30/08/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Primary Care & General Practice

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

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

"ROR"	https://ror.org/03angcq70

Funders

Funder type

Government

NIHR CLAHRC-Oxford; NIHR CLAHRC-West Midlands; NIHR School for Primary Care Research

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?
Protocol article	protocol	05/02/2016		Yes	No
Results article	results	17/09/2019	15/10/2020	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

15/10/2020: Publication reference and total final enrolment number added.
11/12/2018: No publications found, verifying study status with principal investigator.
18/02/2016: Publication reference added.