HABIT (Health After Birth Intervention Trial)
Research type
Research Study
Full title
A feasibility randomised controlled trial investigating the effect of a kilocalorie controlled, low carbohydrate dietary intervention, behavioural modification and telehealth versus a standard 1:1 NHS weight management programme in post-partum women living with obesity
IRAS ID
292812
Contact name
Ashleigh Graham
Contact email
Sponsor organisation
Queen Margaret University
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
Title: A feasibility randomised controlled trial investigating the effect of a kilocalorie controlled, low carbohydrate dietary intervention, behavioural modification and telehealth versus a standard 1:1 NHS weight management programme in post-partum women living with obesity 1) Does the data suggest a greater reduction in bodyweight in the experimental group than the NHSL 1:1 programme in postpartum women with obesity 2) Does the data suggest greater improvement in body composition, blood pressure, waist circumference, quality of life, nutritional adequacy, Physical Activity levels, general wellbeing, hunger and eating cues emotional eating 3) Does the data suggest a significant difference in dietary fat intakes between experimental and NHSL 1:1 programme groups. This study is of importance as it is testing a novel intervention involving a low carbohydrate dietary intervention, an area gaining interest in clinical practice and research. The research area is post-partum women living with obesity. Women who have recently given birth or about to give birth who had a Body Mass Index of 30kg/m2 or greater at their initial booking appointment will be eligible to participate in the study. Data will be collected with consideration of COVID-19, data may be collected in the participants own home, an agreed outpatient clinical site within NHS Lothian or, the patient will self-report selected measures. The study consists of a 3 month intervention with proposed follow up at 6 and 8 months. Participants will either undergo the 1:1 NHS Lothian weight management programme or the study experimental 1:1 programme (adapted from NHSL 1:1 programme)consisting of a low carbohydrate dietary focus. This study aims to test the feasibility of a non-conventional weight loss intervention with view of identifying strategies to reduce overall obesity incidence (including post-partum weight retention) and risk of Type 2 DM development amongst women of childbearing age.
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0068
Date of REC Opinion
31 May 2021
REC opinion
Favourable Opinion