Health After Birth Intervention Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Feasibility RCT Investigating the Effect of a Kilocalorie Controlled, Low Carbohydrate Dietary Intervention, Behavioural Modification and Telehealth vs a Standard 1:1 NHS Weight Management Programme in Post-partum Women Living With Obesity

Conditions
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Obesity

Intervention / Treatment
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* Other: Adapted NHS weight management 1:1 programme
* Other: NHS 1:1 weight management programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Feasibility Randomised Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Adapted NHS weight management 1:1 programme. Low carbohydrate dietary focus, enhanced behaviour change via telehealth, daily step target supported by pedometers | Other: Adapted NHS weight management 1:1 programme<br>* Adapted NHS 1:1 weight management programme with a low carbohydrate dietary focus, incorporating enhanced behaviour change via telehealth, step count and pedometer<br>|
| Active Comparator: Active comparator NHS 1:1 weight management programme<br>12 week NHS 1:1 weight management programme | Other: NHS 1:1 weight management programme<br>* NHS 1:1 weight management programme<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bodyweight (Kilograms) | Bodyweight measured by the CI or self-reported | Proposed 0,3,6,8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body composition (Fat mass/fat free mass) | Medical grade | Proposed 0,3,6,8 months | 
| Change in Waist circumference (Centimetres) | SECA Ergonomic measuring tape | Proposed 0,3,6,8 months | 
| Change in systolic and diastolic Blood pressure | Standard technique | Proposed 0,3,6,8 months | 
| Change in Physical activity levels | Level of physical activity (minutes) and step count from pedometer data | Proposed 0,3,6,8 months | 
| Change in emotional eating using the Weight loss Readiness Test II | Incidence of emotional eating (if present) determined by change score. Increased score is less favourable | 0,3,6,8 months | 
| Change in hunger and eating cues using the Weight loss Readiness Test II | Hunger and eating cues determined by change score. Increased score is less favourable | 0,3,6,8 months | 
| Change in psychological distress (if present) using the Clinical Outcomes in Routine Evaluation-10 screening tool | Measured using the Clinical Outcomes in Routine Evaluation-10 tool using change scores. An increased score is less favourable | Baseline, post-intervention at 3 months | 
| Change in Quality of life | Measured using the World Health Organisation Quality of life (BREF) tool. A lower score is less favourable | Proposed 0,3,6,8 months | 
| Food frequency questionnaire | Standard validated tool | Baseline | 
| Diet quality | Diet quality measured using a 3 day unweighed food diary | Proposed 0,3,6,8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight management postpartum