3C-P Study(Calorie,Carbohydrate,Cognition-Physical Activity(Version1)

• Research type

  Research Study

• Full title

  A feasibility study investigating the effect of a calorie controlled, low carbohydrate diet, cognitive behavioural therapy and physical activity on body composition, eating behaviours, quality of life and biochemical markers in morbidly obese women within one year post-partum; with and without telehealth

• IRAS ID

  223029

• Contact name

  Ashleigh Graham

• Contact email

  agraham2@qmu.ac.uk

• Sponsor organisation

  Queen Margaret University

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  Obesity, defined as abnormal or excessive fat accumulation as a result of energy imbalance and dysregulation, is considered a 21st century epidemic with a worldwide rise in prevalence.Obesity is considered a chronic infalmmatory condition with complex aetiology,associated with the development of conditions such as dementia, osteoarthritis, non-alcoholic fatty liver disease and certain cancers. Obesity-related metabolic dysfunction results in complications such as cardiovascular disease, the metabolic syndrome and Type 2 Diabetes.Obesity is also associated with poorer health-related quality of life and greater susceptibility to mental health problems. Within the UK, prevalence is greatest amongst women, with half of women of childbearing age overweight or obese. Previous research indicates that maternal obesity predicts childhood obesity and increased risk of offspring developing chronic disease in later life.The post-partum(after birth)period has been identified as an optimal timeframe in which to support weight loss however evidence is limited within this area from which to inform practice.A review of the literature identifies a number of studies investigating the efficacy of diet and physical activity however, few of these were UK based and many included differing protocols and variable study design.
  The proposed study is a three-armed feasibility study which aims to incorporate a non-conventional low carbohydrate approach, along with physical activity and cognitive behavioural therapy (CBT) with. A control group will be included with no intervention. The non-conventional and somewhat controversial approach of a low carbohydrate diet to promote weight loss has been investigated elsewhere, with evidence convincing. Florence is a secure text messaging system currently trailed elsewhere within the NHS - this will form the telehealth element of the current study. The study will investigate changes in body weight, body composition, psychology, eating behaviour, quality of life, liver function and cardio-metabolic risk factors with and without the use of telehealth

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  17/NS/0084

• Date of REC Opinion

  5 Sep 2017

• REC opinion

  Favourable Opinion