Obesity
Conditions
Keywords
weight management postpartum
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.
Interventions
OTHERAdapted NHS weight management 1:1 programme
Adapted NHS 1:1 weight management programme with a low carbohydrate dietary focus, incorporating enhanced behaviour change via telehealth, step count and pedometer
OTHERNHS 1:1 weight management programme
NHS 1:1 weight management programme
Sponsors
NHS Lothian
Queen Margaret University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Feasibility Randomised Controlled Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bodyweight (Kilograms) | Proposed 0,3,6,8 months | Bodyweight measured by the CI or self-reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waist circumference (Centimetres) | Proposed 0,3,6,8 months | SECA Ergonomic measuring tape |
| Change in systolic and diastolic Blood pressure | Proposed 0,3,6,8 months | Standard technique |
| Change in Physical activity levels | Proposed 0,3,6,8 months | Level of physical activity (minutes) and step count from pedometer data |
| 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 Body composition (Fat mass/fat free mass) | Proposed 0,3,6,8 months | Medical grade |
| 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 |
| 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 |
| Food frequency questionnaire | Baseline | Standard validated tool |
| Diet quality | Proposed 0,3,6,8 months | Diet quality measured using a 3 day unweighed food diary |
| 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 |
Countries
United Kingdom
Outcome results
None listed