PRE-BABE: Pre-conception weight loss for women above a healthy weight: a pilot randomized controlled trial

Phase 2

Completed

• Conditions: overweight women (BMI>25kg/m2); Diet and Nutrition - Obesity; Reproductive Health and Childbirth - Antenatal care; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12620000597998
• Lead Sponsor: Impromy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-22
• Study Completion: 2020-12-21
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

–Women with a BMI greater than or equal to 25kg/m2;
–Aged >/= 18 - 40 years;
–Willing to attend CPA RPA clinic on 3 occasions;
–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 or type 2 diabetes.
–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;
–A person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in weight (in kg) between week 0 and week 10<br>Measured in person using identical digital scales<br>[Weight in kg at completion of the 10 week program ];Acceptability <br><br>Both arms: Study specific questions on whether the program worked for them, would they recommend to other women planning pregnancy, did they feel supported.. Australian online eating survey at baseline and 4 weeks post completion of the program.[At the completion of the 10 week program]