Overweight and Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. BMI =28 kg/m2 2. Aged =18 years 3. Willing and able to comply with the study procedures For simplicity, we will not vary the BMI criteria by ethnic group.
Exclusion criteria
Exclusion criteria: 1. Planned or current pregnancy in the next two years 2. Previous or planned bariatric surgery GPs will be allowed to define any additional inclusion/exclusion criteria to meet local practice and will be asked to provide details on these for the reporting of the study. No further criteria will be imposed, thus capturing the population that would typically be referred to these treatments. Participants receiving other weight loss treatments, e.g. Orlistat, will not be excluded as such participants would still be eligible for commercial referrals in standard practice, but this will be adjusted for in the analyses. Participants will be randomised to intervention arms, and thus those receiving additional treatment should be evenly spread across the interventions and these treatments will be accounted for in the cost-effectiveness analyses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group differences in change in body weight (kg) from 0 to 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anthropometric measures: Participants will be asked to remove shoes and heavy clothing items. Height will be measured in cm by stadiometer. Waist circumference will be measured in cm using a tape measure. Weight and fat mass will be measured in kg using a Tanita segmental body composition analyser, which measures fat mass by bioelectrical impedance. Fat mass is more closely related to health risks than BMI at an individual level and this is a measure that could be used in routine clinical practice. Blood pressure will be measured using standardised methods. 2. Economic evaluation: The incremental cost-effectiveness ratio (ICER) of the intervention is the main outcome of the economic evaluation and will be expressed as incremental costs per incremental change in weight/BMI for the within-trial evaluation. NICE generally accepts that an intervention is cost effective if it has an incremental cost-effectiveness ratio of less than £20,000 per Quality Adjusted Life Year (QALY), and there should be increasingly strong reasons for accepting as cost effective interventions with an incremental cost-effectiveness ratio of over £30,000 per QALY. Primary care providers (in collaboration with the PCRN and with appropriate consent) will provide research staff with access to patient records to collect data at 12 and 24 months on all recorded health care usage, including any changes in medication. Participants will also complete a self-report measure of Quality of Life (EQ5D) and a resource use questionnaire covering health service attendances and any weight loss treatment for the previous 3 months. These data will be combined with data on medication and health care usage obtained from the primary care provider. 3. Psychosocial Factors: Demographic data on age, gender, ethnic group, and SES (occupation, highest level of education) will be self- reported. WW attendance, website usage and weights measured at WW will be recorded by the WW NHS Referral Scheme database and with c | — |
Countries
England, United Kingdom