Obesity and other hyperalimentation Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Newly referred patients meeting standard criteria for specialist weight management referral (BMI >40 kg/m2, or >35 kg/m2 with comorbidity, and adjusted for ethnicity) will be invited to participate in the study. 2. Patients must satisfy all of the following criteria to be enrolled in the study: 2.1. Registered with the participating NHS site 2.2. Aged >=18 years 2.3. Willing to have weight measured on two occasions (at consent and 6 months) 2.4. Considered suitable for group-based care 2.5. Have the capacity to consent
Exclusion criteria
Exclusion criteria: 1. Aged under 18 years 2. Currently engaged in any other weight management trial 3. Unwilling or unable to attend the intervention/UC appointments 4. Intending to relocate outside the geographical region during the trial period 5. Participants who have significant difficulties in adequate understanding of English or a sensory impairment, such that they are unable to sufficiently understand/access the trial documentation or engage in intervention/UC appointments, in the absence of a local provision of translated materials or communication aids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of delivering the PROGROUP-online intervention, assessed using: 1. Recruitment rate (number of participants enrolled over the recruitment period) 2. Intervention uptake (proportion of eligible patients consenting to participate) 3. Attendance (proportion of scheduled sessions attended by participants) 4. Programme completion rate (proportion of participants completing the intervention) Time frame: recruitment period (4 months) and intervention period (5 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Acceptability of the PROGROUP-online intervention, assessed using qualitative interviews with participants and healthcare professionals exploring experiences of participation and delivery. Time frame: during and immediately after the intervention period (5 months) 2. Fidelity of intervention delivery, assessed through process evaluation methods, including review of intervention delivery against the planned protocol. Time frame: throughout the intervention period (5 months) 3. Patient preferences for PROGROUP-online, including factors influencing participation or non-participation, assessed using: 3.1. Qualitative data from participants and non-participants 3.2. Brief demographic and preference data from those declining participation Time frame: recruitment period and early intervention phase 4. Health economic outcomes, including: 4.1. Cost of delivering the PROGROUP-online intervention 4.2. Comparison with usual care Time frame: during intervention delivery and analysis phase 5. Travel-related outcomes: estimated travel time and cost savings for participants receiving PROGROUP-online compared to in-person care. Time frame: during intervention period. 6. Intervention engagement metrics, including: 6.1. Session attendance rates 6.2. Retention throughout the programme Time frame: during intervention period (5 months) | — |
Countries
England, United Kingdom