Clinical trial NCT05137691: Health After Birth Intervention Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: weight management postpartum
Lead sponsor: Queen Margaret University
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2021-11-30
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility Randomised Controlled Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Bodyweight (Kilograms)
timeFrame: Proposed 0,3,6,8 months
Secondary outcomes:
measure: Change in Body composition (Fat mass/fat free mass)
timeFrame: Proposed 0,3,6,8 months
measure: Change in Waist circumference (Centimetres)
timeFrame: Proposed 0,3,6,8 months
measure: Change in systolic and diastolic Blood pressure
timeFrame: Proposed 0,3,6,8 months
measure: Change in Physical activity levels
timeFrame: Proposed 0,3,6,8 months
measure: Change in emotional eating using the Weight loss Readiness Test II
timeFrame: 0,3,6,8 months
measure: Change in hunger and eating cues using the Weight loss Readiness Test II
timeFrame: 0,3,6,8 months
measure: Change in psychological distress (if present) using the Clinical Outcomes in Routine Evaluation-10 screening tool
timeFrame: Baseline, post-intervention at 3 months
measure: Change in Quality of life
timeFrame: Proposed 0,3,6,8 months
measure: Food frequency questionnaire
timeFrame: Baseline
measure: Diet quality
timeFrame: Proposed 0,3,6,8 months
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Astley Ainslie Hospital
Study officials:
affiliation: Queen Margaret University
name: Ashleigh Graham
role: PRINCIPAL_INVESTIGATOR
References: