Can a pre-conception weight loss program improve maternal and infant outcomes for women with overweight or obesity? A pragmatic randomised controlled trial (RCT).

Phase 3

Recruiting

Conditions: Women with overweight (BMI greater than 25kg/m2 to less than 30kg/m2 )
Women with obesity BMI greater than 30kg/m2
Diet and Nutrition - Obesity
Reproductive Health and Childbirth - Antenatal care
Reproductive Health and Childbirth - Childbirth and postnatal care

Registration Number: ACTRN12620001238965

Lead Sponsor: The University of Sydney

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 1927

Inclusion Criteria

– Women with a BMI greater than or equal to 25kg/m2
- Planning a pregnancy within 6 to 12 months
– Willing to attend 3 consults either in the clinic or via telehealth
- Provide pregnancy and birth details to the research team
– Willing to follow a weight loss dietary protocol for 10 weeks
– Has been weight stable (i.e. less than 3 kg weight loss) for the past 2 months.

Exclusion Criteria

– Significant pre-existing, diagnosed medical condition that may prevent them from participating in the study, including but not limited to: Kidney disease or renal impairment; Gall bladder disorders or stones; Liver disease (e.g. cirrhosis); severe cardiovascular disease where rapid weight loss is contraindicated eg Cardiac arrhythmia, congenital heart disease; Malabsorptive Gastrointestinal disease (including celiac, Crohns disease);
– History of bariatric surgery;
– Severe depression;
– Cancer (unless benign or non-progressive skin cancer);
– Type 1 diabetes and type 2 diabetes if on insulin.
– Regular use of medications prescribed by a medical practitioner that are deemed unsuitable for this trial – as determined by the appointed study physician during screening process;
– A food allergy/intolerance to, or not willing to consume, the foods prescribed in the protocol;
- Postpartum <6 months or currently breastfeeding;
– A person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol;
- A person unable to to provide informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite perinatal outcome including one or more of the following maternal and infant outcomes: 1. Maternal outcomes (gestational diabetes mellitus; pre-eclampsia; first Caesarean section) 2. Infant outcomes (perinatal death; LGA (birth weight >90th centile); admission to a neonatal unit).[ Assessed within 1 month after birth by access to electronic medical record and perinatal data]

Secondary Outcome Measures