ISRCTN75323409CompletedNot Applicable
ifestyle intervention during pregnancy to minimize downstream obesity in mother and child: a single centre randomised controlled pilot trial with a two-arm, parallel-group design
Children?s Hospital of Eastern Ontario Research Institute (CHEORI) (Canada)0 sites60 target enrollmentStarted: August 28, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •Current inclusion criteria as of 03/08/2012:
- •1. Normal weight, overweight or obese pregnant women (pre-pregnancy BMI greater than 18.5 kg/m2)
- •2. Aged 18 years or older
- •3. Known to be carrying a singleton foetus
- •4. Plans to deliver locally and keep the infant
- •5. Given medical clearance by their health care provider, based on their PARmed-X for Pregnancy questionnaire
- •Previous inclusion criteria until 03/08/2012
- •1. Overweight or obese pregnant primparous (i.e., first-time mothers) women (pre-pregnancy BMI greater than 25 kg/m^2)
Exclusion Criteria
- •1. Smokers
- •2. Have medical conditions that might impact body weight (untreated thyroid disease, insulin treated diabetes, hypertension requiring medication)
- •3. Have known contraindications to exercise as outlined in the joint Society of Obstetricians and Gynaecologists of Canada (SOGC)/ Canadian Society for Exercise Physiology (CSEP) clinical practice guidelines
- •4. Present absolute contraindications such as:
- •4.1. Ruptured membranes
- •4.2. Preterm labour
- •4.3. Hypertensive disorders of pregnancy
- •4.4. Incompetent cervix
- •4.5. Restricted foetal growth
- •4.6. Placental previa after 28th week
- •4.7. Persistent 2nd or 3rd trimester bleeding
- •4.8. Any serious cardiovascular, respiratory or systemic disorder
- •5. Presenting the following relative contraindications:
- •5.1. Second trimester abortion or greater than two abortions
- •5.2. Moderate/significant cardiovascular or respiratory disorders
- •5.3. Anaemia (Hb less than 100 g/L)
- •5.4. Malnutrition/eating disorder
- •5.5. Twin pregnancy after 28th week
- •5.6. Any other significant medical condition
- •Warning signs to terminate exercise while pregnant include vaginal bleeding, significant dyspnoea prior to exertion, dizziness, headache, chest pain, muscle weakness, calf pain or swelling (rule out thrombophlebitis), preterm labour, and amniotic fluid leakage.
Investigators
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