TRiM – Trial for Reducing Weight Retention in New Mums: A randomised controlled trial investigating the effectiveness of an innovative postpartum weight loss program.

Not Applicable

Completed

• Conditions: Postpartum weight retention; Dietary intake/diet quality; Insulin resistance; Diet and Nutrition - Obesity; Reproductive Health and Childbirth - Childbirth and postnatal care; Metabolic and Endocrine - Normal metabolism and endocrine development and function

• Registration Number: ACTRN12611000873921
• Lead Sponsor: Dr Shelley Wilkinson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

pre-pregnancy BMI > 25kg/m2, can read and speak English to a level that allows completion of intervention worksheets, and > 18years.

Exclusion Criteria

live outside the MMH catchment area, have delivered <36/40, have a pre-pregnancy diagnosis of type 1 or type 2 diabetes mellitus, or have a history of substance use or have a severe medical or psychological diagnosis that would prevent participation within the intervention

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Our primary hypothesis is that women in the intervention group will lose significantly more weight than women in the control group. This will be determined through an anthropometric assessment (weight will be measured to the nearest 0.1 kg using a spring balance scale).[36 weeks pregnancy, 6 weeks postpartum, 6 months post partum]

Secondary Outcome Measures

Name	Time	Method
1. have significantly better diet quality (using validated diet quality questionnaire -the 'Fat and Fibre' index)[36 weeks pregnancy, 6 weeks postpartum, 6 months post partum];2. undertake significantly more minutes of physical activity (AWAS - valid and reliable Australian Women's Activity Survey)[36 weeks pregnancy, 6 weeks postpartum, 6 months post partum];3. demonstrate significantly higher breastfeeding rates<br>(valid and reliable breastfeeding (and breastfeeding intention- survey from Nommsen-Rivers & Dewey (2009) Development and validation of the infant feeding intentions scale. Matern Child Health J, 13:334-342).[6 weeks postpartum, 6 months post partum];4. have significantly better fasting glucose and insulin levels (clinical measurements - blood tests)[36 weeks pregnancy, 6 weeks postpartum, 6 months post partum];5. significantly lower fat mass (FM) and significantly higher fat free mass (FFM).[Bioelectrocal impedence assay; 6 weeks postpartum, 6 months post partum]