NCT01770522

Brief Summary

It is well known that being overweight or obese increases the risk of health problems, and that many people find it difficult to maintain a healthy weight. Worryingly the rise in obesity is greater in women than in the male population. One possible reason for this is that some women gain too much weight during their pregnancy and find it difficult to lose this weight after the birth of their baby. For example, women who gain more weight than recommended during pregnancy have been shown to be more likely to carry excess that weight at 1 and 15 years after pregnancy, compared to women who gained the recommended amount of weight. There are currently no evidence-based guidelines in the UK for how weight should be managed during pregnancy. For these reasons, it is really important that we understand the factors affecting weight management before, during and after pregnancy. The aim of this research is therefore to find successful approaches to help women manage their weight before, during and after pregnancy. This will be completed by understanding the knowledge, attitudes, experiences and expectations of women during and after pregnancy and to identify the factors (e.g. diet, physical activity, poor social network etc.) which influence body weight. This will enable us to suggest better strategies for promoting healthy weight changes during and after pregnancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

1.6 years

First QC Date

January 15, 2013

Last Update Submit

February 7, 2019

Conditions

Keywords

BodyweightPhysical AcivitiyDietBodymass indexPregnancyPostnatal

Outcome Measures

Primary Outcomes (1)

  • Weight change during pregnancy and postnatal period

    To determine the weight change during pregnancy and postnatal period related to pre-pregnancy weight

    18 months +/- 2 months

Secondary Outcomes (1)

  • Secondary outcomes

    18 months +/- 2 months

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Particpants will be approached at their routine 12 or 20 weeks prnatal scan at the antenatal scanning clinics at the Queens Medical Centre, Nottingham.

You may qualify if:

  • Participants will be pregnant women at 12 or 20 weeks pregnancy attending the 12 and 20 week antenatal scanning clinics at the Queens Medical Centre, Nottingham
  • Participants will be able to give informed consent- Participants will be over the age of 18
  • Participants will be able to read English - due to the nature of the study we will not be able to print the questionnaires in various languages.
  • Participants will be of any sociodemographic backgrounds, bodyweights and parity.

You may not qualify if:

  • Participants who do not feel that their literacy or English language skills will enable them to complete the questionnaires will be offered the opportunity to have one of the research team read the questions and fill in the answers for them. Whilst doing this and being sensitive to literacy and language issues, the nature of this feasibility study means that the research team will not offer an interpreting service or produce documents in languages other than English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Nottingham Hospital

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (2)

  • Swift JA, Pearce J, Jethwa PH, Taylor MA, Avery A, Ellis S, Langley-Evans SC, McMullen S. Antenatal Weight Management: Women's Experiences, Behaviours, and Expectations of Weighing in Early Pregnancy. J Pregnancy. 2016;2016:8454759. doi: 10.1155/2016/8454759. Epub 2016 Oct 24.

    PMID: 27843648BACKGROUND
  • Swift JA, Langley-Evans SC, Pearce J, Jethwa PH, Taylor MA, Avery A, Ellis S, McMullen S, Elliott-Sale KJ. Antenatal weight management: Diet, physical activity, and gestational weight gain in early pregnancy. Midwifery. 2017 Jun;49:40-46. doi: 10.1016/j.midw.2017.01.016. Epub 2017 Jan 31.

Study Officials

  • Preeti H Jethwa, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR
  • Helen Budge, PhD

    Queens Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 17, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

February 8, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Currently there is no plan to share data with other researchers, only publications

Locations