Obesity Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men aged =18 years 2. BMI =30 kg/m² 3. Understand study information and able to give informed consent 4. Resident in and around Glasgow, Belfast, or Bristol
Exclusion criteria
Exclusion criteria: 1. Inability to understand the trial or the English language SMS intervention 2. No mobile phone access 3. Planning to move out of the area within 12 months 4. Current or recent (within last 6 months) participation in a research weight loss intervention study (participants from the feasibility study are welcome to participate in this RCT) 5. Plan to have bariatric surgery within 12 months 6. For GP screening prior to sending invitation letters: 6.1. Known terminal illness or severe psychiatric illness 6.2. Known impaired cognitive or visual function that would limit understanding of study information and SMS 7. Whilst there is no upper age limit exclusion to this trial, researchers taking consent will be trained to consider whether participation is appropriate for individual participants (for example the levels of frailty allowing standard weighing procedures to be followed or sufficient cognition to understand consent and participation procedures)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss is measured as % of baseline at 12 months measured using calibrated medical scales at baseline and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 18/05/2023: 1. Weight loss is measured in kg using calibrated medical scales at baseline, 3, 6, 12, and 24 months 2. Mental well being is measured by the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline and 12 months, and the EuroQol 5-dimension (EQ-5D) quality of life questionnaire (Anxiety and Depression Dimension) and PHQ-4 at baseline, 12, and 24 months 3. Health economic outcomes are measured by the EQ-5D quality of life questionnaire and NHS Health care use questionnaires at baseline, 12, and 24 months 4. Health behaviours (physical activity, smoking status, and alcohol intake) measured using a self-report questionnaire at baseline and 12 months 5. Weight management strategies used measured by self-report questionnaire at baseline, 12, and 24 months 6. Confidence in ability to lose and maintain weight loss is measured by self-report questionnaire at baseline and 12 months 7. Weight stigma is measured by WSSQ at baseline and 12 months 8. Participant satisfaction is measured by self-report questionnaire at 12 months 9. Experience and behaviours is examined through qualitative data taken in interviews at 12 and 24 months _____ Previous secondary outcome measures as of 14/12/2021: 1. Weight loss is measured in kg using calibrated medical scales at baseline, 3, 6, 12, and 24 months 2. Mental well being is measured by the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) and PHQ4 at baseline and 12 months 3. Health economic outcomes are measured by the EuroQol 5-dimension (EQ-5D) quality of life questionnaire and NHS Health care use questionnaires at baseline, 12, and 24 months 4. Health behaviours (physical activity, smoking status, and alcohol intake) measured using a self-report questionnaire at baseline and 12 months 5. Weight management strategies used measured by self-report questionnaire at baseline, 12, and 24 months 6. Confidence in ability to lose and maintain weight loss is measured by self-report | — |
Countries
England, Northern Ireland, Scotland, United Kingdom