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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in Bodyweight (Kilograms)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Bodyweight (Kilograms)
时间窗: Proposed 0,3,6,8 months
Bodyweight measured by the CI or self-reported
次要结局
- Change in Waist circumference (Centimetres)(Proposed 0,3,6,8 months)
- Change in emotional eating using the Weight loss Readiness Test II(0,3,6,8 months)
- Change in hunger and eating cues using the Weight loss Readiness Test II(0,3,6,8 months)
- Change in Body composition (Fat mass/fat free mass)(Proposed 0,3,6,8 months)
- Change in systolic and diastolic Blood pressure(Proposed 0,3,6,8 months)
- Change in psychological distress (if present) using the Clinical Outcomes in Routine Evaluation-10 screening tool(Baseline, post-intervention at 3 months)
- Diet quality(Proposed 0,3,6,8 months)
- Change in Quality of life(Proposed 0,3,6,8 months)
- Change in Physical activity levels(Proposed 0,3,6,8 months)
- Food frequency questionnaire(Baseline)
研究者
Ashleigh Graham
Senior Practitioner in clinical research and Principal investigator
Queen Margaret University