Managing Weight in Pregnancy (MAGIC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01770522
First received: January 15, 2013
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition
Determine Changes in Weight During Pregnancy and Postnatal Period.

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: A Longitudinal Study Exploring Factors Influencing Weight Gain During Pregnancy and Subsequent Weight Loss and Retention up to One Year Postpartum

Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Weight change during pregnancy and postnatal period [ Time Frame: 18 months +/- 2 months ] [ Designated as safety issue: No ]
    To determine the weight change during pregnancy and postnatal period related to pre-pregnancy weight


Secondary Outcome Measures:
  • Secondary outcomes [ Time Frame: 18 months +/- 2 months ] [ Designated as safety issue: No ]
    Expectations for weight change during and after pregnancy, their experiences of antenatal care and knowledge of recommendations, and their diet and levels of physical activity


Estimated Enrollment: 167
Study Start Date: January 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Participants will be excluded from the postnatal phase of the study if they deliver their baby prematurely (before 37 weeks of gestation) or do not give birth to a live baby. These exclusions are required, as premature birth or fetal loss/still birth would be expected to have an impact on psychological and physiological aspects linked to weight management which are not relevant to our specific research objectives. Information on birth outcome will be gained by accessing hospital records, and only women who have given birth to a live baby after 37 weeks of gestation will be contacted by the study team in the postnatal period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770522

Locations
United Kingdom
Univeristy of Nottingham Hospital
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Preeti H Jethwa, PhD University of Nottingham
Principal Investigator: Helen Budge, PhD Queens Medical Centre
  More Information

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01770522     History of Changes
Other Study ID Numbers: 12068 MAGIC
Study First Received: January 15, 2013
Last Updated: April 9, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Nottingham:
Bodyweight
Physical Acivitiy
Diet
Bodymass index
Pregnancy
Postnatal

ClinicalTrials.gov processed this record on August 28, 2014