K Pregnancies Better Eating and Activity Trial

Not Applicable

Completed

• Conditions: Obesity during pregnancy; Nutritional, Metabolic, Endocrine; Obesity

• Registration Number: ISRCTN89971375
• Lead Sponsor: King's College London (UK)

Brief Summary

2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23855708 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25300266 pilot study results 2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/24533897 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24798080 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26165396 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27894316 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/29140440 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30661507 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35359001/ maternal altered lipid metabolism and associations with offspring adiposity (added 01/04/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36224375/ (added 13/10/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36584215/ Secondary analysis of clinical history and clinical/anthropometric measures (added 03/01/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36950879/ subgroup assessment (added 24/03/2023) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/39048696/ Secondary analysis (added 29/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-28
• Study Completion: 2017-03-01
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1158

Inclusion Criteria

1. Willing and able to give informed consent
2. Pregnant women with booking body mass index (BMI) greater than or equal to 30 kg/m^2
3. Singleton pregnancy

Exclusion Criteria

Current exclusion criteria as of 06/06/2012:
1. Unwilling or unable to give informed consent
2. Pregnant women with booking BMI less than 30 kg/m^2
3. Multiple pregnancy
4. Pre-existing diabetes mellitus
5. Pre-existing hypertension requiring treatment, pre-existing thyroid and renal disease, current psychosis, sickle cell disease, thalassemia, coeliac disease

Previous exclusion criteria:
1. Unwilling or unable to give informed consent
2. Pregnant women with booking BMI less than 30 kg/m^2
3. Multiple pregnancy
4. Pre-existing diabetes mellitus

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure(s):<br>1. Maternal: GDM by HAPO criteria. <br>2. Infant: macrosomia (>90th customised birthweight centile). <br><br>Previous primary outcome measure(s):<br>Improved maternal glucose sensitivity, assessed at recruitment (10 - 16 weeks), and again in the third trimester (32 - 36 weeks).

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measure(s):<br>1. Maternal: complications in pregnancy (inc GDM, pre-eclampsia, depression, quality of life), physical activity, diet, gestational weight gain, maternal body composition (skin folds), mode of delivery, hospital admissions. Health economic assessment. <br>2. Infant: adverse outcomes, neonatal unit admissions, SGA, LGA, body composition (skin folds). <br>3. At 6 months post partum: maternal and child diet and physical activity. Maternal general health (inc depression, quality of life). Maternal and child body composition. Childhood modifiers/modulators of obesity. <br>4. 3 years: To be confirmed; measures of maternal and child body composition, diet, physical activity. Childhood mental health, cardiovascular function. <br><br>Previous secondary outcome measure(s):<br>Reduction in foetal, maternal and pregnancy complications, assessed at recruitment (10 - 16 weeks), and again in the third trimester (32 - 36 weeks).