Status:
COMPLETED
Healthy Habits in Pregnancy and Beyond
Lead Sponsor:
Queen's University, Belfast
Collaborating Sponsors:
University of Leeds
University College, London
Conditions:
Overweight and Obesity
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
More than 50% of pregnant women are considered to have a BMI that is classified as overweight or obese when they present for antenatal care. Overweight and obesity in pregnancy is associated with comp...
Detailed Description
The primary objective of the feasibility study is to provide a decision on whether to proceed to a full-scale, multicentre RCT. The two-arm randomised controlled feasibility study will: 1. Assess th...
Eligibility Criteria
Inclusion
- Pregnant Women.
- Body Mass Index between ≥25.0 kg/m2 and \<38.0 kg/m2.
- Primiparous or Multiparous.
- Women capable of providing informed consent and of providing consent on behalf of their child.
Exclusion
- Twin or multiple pregnancies.
- Insufficient English to understand intervention and written materials.
- Nutritional complications i.e. previous or current eating disorder, following a special diet, in receipt of specialist dietary advice.
- Pregnancy not viable as determined by the patient's clinical team.
- Have been referred to another weight management service by their clinical team during pregnancy that is not part of routine antenatal care.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04336878
Start Date
March 1 2021
End Date
September 25 2022
Last Update
February 20 2024
Active Locations (1)
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1
Centre for Public Health, Queen's University Belfast
Belfast, United Kingdom, BT12 6BA