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Recruitment challenges
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| Name | Class |
|---|---|
| NHS Lothian | OTHER_GOV |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Adapted NHS weight management 1:1 programme. Low carbohydrate dietary focus, enhanced behaviour change via telehealth, daily step target supported by pedometers |
|
| Active comparator NHS 1:1 weight management programme | Active Comparator | 12 week NHS 1:1 weight management programme |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted NHS weight management 1:1 programme | Other | Adapted NHS 1:1 weight management programme with a low carbohydrate dietary focus, incorporating enhanced behaviour change via telehealth, step count and pedometer |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bodyweight (Kilograms) | Bodyweight measured by the CI or self-reported | Proposed 0,3,6,8 months |
| 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 |
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Inclusion Criteria:
Additional study specific criteria
Exclusion Criteria:
Additional study specific criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ashleigh Graham | Queen Margaret University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Astley Ainslie Hospital | Edinburgh | EH9 2HL | United Kingdom |
Only anonymised data will be accessible by the rest of the current research team for purpose of statistical analysis and monitoring
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Feasibility Randomised Controlled Trial
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| NHS 1:1 weight management programme | Other | NHS 1:1 weight management programme |
|
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |