Topic: Primary Care Research Network for England
Conditions
Interventions
1. Control, very brief advice and follow up
2. Web and minimal nurse support, minimal face to face contact with nurse
3. Web and nurse support, Web intervention with intensive nurse support
Follow-up length: 12 month(s)
Sponsors
University of Southampton (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult male and female patients with a body mass index (BMI) over 30 (or 28 with hypertension or or hypercholesterolaemia)
Exclusion criteria
Exclusion criteria: 1. Current mental health problems 2. Very ill or unable to change diet 3. Pregnancy or breastfeeding 4. Perceived inability to walk 100 metres
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome measure (08/12/2015): 1. The average weight reduction over 12 months, measured blind to randomisation group using Tanita digital scales measured at baseline, 6, and 12 months. 2. A secondary analysis of weight is the number of individuals who maintain a clinically important 5% weight reduction measured using Tanita digital scales measured at 6 and 12 months. Original outcome measure: Weight measured at baseline, 6, and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Food and drink consumption measured using Food Frequency Questionnaires at baseline, 6, and 12 months 2. Physical activity measured using the Godin physical activity questionnaire at baseline, 6, and 12 months 3. Waist circumference in cm measured by tape measure at baseline, 6, and 12 months 4. Blood pressure (BP) in mm Hg measured using a validated Omron device at baseline, 6, and 12 months 5. Serum Glucose and HbA1c in mmol/l measured at baseline, 6, and 12 months 6. Serum lipids (cholesterol/HDL/LDL/triglyceride) in mmol/l measured at baseline, 6, and 12 months 7. Body composition measured using Tanita digital scales to document percentage body fat measured at baseline, 6, and 12 months 8. Serum Liver function tests (AST,ALT,GGT) measured in IU/l to monitor non-alcoholic fatty liver disease at baseline, 6, and 12 months 9. Serum Ferritin in ug/l measured at 12 months 10.A modified version of the Patient Enablement Instrument measured by self-report questionnaire at baseline and 12 months 11. EQ-5D for Health economic analyses measured by self-report questionnaire at baseline, 6, and 12 months. 12. Health service resource use measured from documentation in the medical records in the 12 months prior to randomisation and the 12 months following 13. Reported activities undertaken to lose weight measured by self-report questionnaire at 12 months | — |
Countries
United Kingdom
Outcome results
None listed