Obesity Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-65 years 2. White British or South Asian ethnicity 3. BMI >30 4. Referred from GP 5. No known co-morbidities that may influence dietary intake or weight loss achievement (e.g. type I diabetes; current medication with known weight gain side effect)
Exclusion criteria
Exclusion criteria: 1. Pregnant women 2. Children; Elderly (> 65 years) 3. BMI > 45 4. Persons from other Ethnic groups - multi-ethnic inclusion will increase the complexity of the avatar programme design making it cost prohibitive within this feasibility study. Should outcomes support a full RCT, avatar design programme will be expanded to reflect variations in population ethnicity and demographics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss: body weight (kg) and calculated BMI (kg/m2) assessed at T0-T3 (0, 3 and 6 months). Between-arm variation in actual weight loss will be determined and tested in a full RCT if warranted. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Uptake and continuation rates: uptake (participation) will be evaluated by comparing actual recruitment with number of eligible people expressing interest in the study (timepoint: on invitation to participate in study). Reasons for declining participation will be ascertained where possible. Attendance at time intervals T0-T2 will be used as a proxy for continuation with the weight improvement programme. Details of study attrition will be recorded at times T0 – T2. 2. Quality of life and self-efficacy, assessed using IWQOL-lite, EQ-5D-5L and WEL-SF surveys. Between-arm variation may suggest quality of life and self-efficacy differentials to be tested in a full RCT. Assessment will take place at T0-T3 3. Access to online avatar programme: patient access to avatar programme (including regularity and activity within it) will be monitored as a background computer function of the avatar programme as a proxy for level of interest in avatar technology (T0-T3) 4. Adverse events: no risk to patients as a consequence of study participation is anticipated although stress/anxiety from visualising self as an avatar cannot be excluded. The researcher will seek patient self-reports of adverse events at each attendance and report these to the research team for action as appropriate (T0-T3). If concerns pertain to health and wellbeing, the medical team within the weight loss clinic will be informed and details of concern logged with project team and Trust R&D. Where concern relates to study process, the chief investigator and Trust R&D will be informed. With patient permission, their GP will be informed of their involvement in the study. 5. Refinement of avatar programme design based on focus group feedback from patients and HCPs. This information will inform design of intervention to be adopted in a full RCT if warranted (timepoint: following focus group) 6. Estimates of key aspects of trial including | — |
Countries
England, United Kingdom