Health After Birth Intervention Trial
- Conditions
- Obesity
- Registration Number
- NCT05137691
- Lead Sponsor
- Queen Margaret University
- Brief Summary
This trial is to assess the feasibility of a larger, definitive RCT and determine the clinical effectiveness of an NHS 1:1 programme versus a modified programme with a low carbohydrate dietary intervention (as per Feinman and colleagues classification) with telehealth, physical activity and enhanced behaviour change on specified health outcomes amongst post-partum women living with obesity
- Detailed Description
For individuals living with obesity, the post-partum period is currently the initial, optimal timeframe for weight management. Many women reconceive during the post-partum phase, increasing the risk of between-pregnancy bodyweight retention and even gain. Consequentially, many re-enter subsequent pregnancies with a higher BMI often associated with unfavourable obstetric outcome and further cyclical perpetuation.
Health behaviour change is an important facet within weight management interventions and delivery may be enhanced by digital technologies, for example, telehealth. Short messaging service (SMS) may be used to enhance communication between patients and practitioner and is relatively inexpensive to use.
Low carbohydrate diets continue to gain traction however research is arguably confounded by the lack of a universally agreed definition and classification. Feinman and colleagues (2015) propose intermediary categories. The experimental arm of this trial will be encouraged to adopt a non-ketogenic LCD as per Feinman.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 3
- Adult aged 18 or above
- Ready and motivated to make lifestyle changes
- Have a Body Mass Index of ≥30 kg/m2 (at initial booking appointment)
Additional study specific criteria
- English speaking and ability to read English language
- Capacity to consent to participating in the study
- Are non-diabetic or those with Type 2 diabetes which is diet controlled
- Deemed medically fit by GP/medical professional to participate via email
- Have recently given birth (within 1 year)
- Are not receiving weight management support elsewhere e.g. NHS, Scottish slimmers, weight watchers
- Have access to a mobile phone and weighing scales
- Have uncontrolled hypothyroidism
- Have unstable psychosis or severe and unstable personality disorder
- Are pregnant
- Have dementia
- Have moderate to severe learning disability or learning difficulty which impairs the ability to adhere to the programme (identified by medical history and confirmed with GP)
- Current alcohol or substance misuse (6 month period of abstinence)
- Active purging
- Bulimia Nervosa
- Binge Eating Disorder
Additional study specific criteria
- Known cancers
- Type 1 Diabetes or Type 2 Diabetes on any Diabetic medication (including Insulin)
- Have a pacemaker
- Renal impairment
- Taking Orlistat or any other weight loss medication or had previous bariatric surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Bodyweight (Kilograms) Proposed 0,3,6,8 months Bodyweight measured by the CI or self-reported
- Secondary Outcome Measures
Name Time Method Change in Waist circumference (Centimetres) Proposed 0,3,6,8 months SECA Ergonomic measuring tape
Change in emotional eating using the Weight loss Readiness Test II 0,3,6,8 months Incidence of emotional eating (if present) determined by change score. Increased score is less favourable
Change in hunger and eating cues using the Weight loss Readiness Test II 0,3,6,8 months Hunger and eating cues determined by change score. Increased score is less favourable
Change in Body composition (Fat mass/fat free mass) Proposed 0,3,6,8 months Medical grade
Change in systolic and diastolic Blood pressure Proposed 0,3,6,8 months Standard technique
Change in psychological distress (if present) using the Clinical Outcomes in Routine Evaluation-10 screening tool Baseline, post-intervention at 3 months Measured using the Clinical Outcomes in Routine Evaluation-10 tool using change scores. An increased score is less favourable
Diet quality Proposed 0,3,6,8 months Diet quality measured using a 3 day unweighed food diary
Change in Quality of life Proposed 0,3,6,8 months Measured using the World Health Organisation Quality of life (BREF) tool. A lower score is less favourable
Change in Physical activity levels Proposed 0,3,6,8 months Level of physical activity (minutes) and step count from pedometer data
Food frequency questionnaire Baseline Standard validated tool
Trial Locations
- Locations (1)
Astley Ainslie Hospital
🇬🇧Edinburgh, United Kingdom