Topic: Primary Care Research Network for England
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 13/07/2012: 1. Young people aged 12 - 19 years, either sex 2. Obese (body mass index [BMI] greater than 95th centile for age and sex) Previous inclusion criteria until 13/07/2012: 1. Young people aged 13 - 17 years, either sex 2. Obese (body mass index [BMI] greater than International Obesity Task Force [IOTF] thresholds for age and sex)
Exclusion criteria
Exclusion criteria: Current exclusion criteria: 1. Participants with significant mental health problems or undergoing mental health treatment 2. Other chronic illness, known secondary obesity, monogenic obesity syndrome or use of medications known to promote obesity. Added 06/10/2015: Young people with asthma will be included in the study so long as they have not had more than one course of oral steroids in the preceding 3 months (where course is less than or equal to 5 days), or are on more than the first starting dose of inhaled steroids as per British Thoracic Society Guidelines. 3. Participants with significant learning disability 4. Participants with lack of command of English sufficient to render them unable to participate effectively in the planned intervention. The great majority of eligible young people from black or minority ethnic groups in this population have good command of English. Given the importance of standardising the intervention, it will not be possible to use interpreters to enable parents with poor English to participate. To allow as many young people as possible to participate while maintaining the external validity of the study, we will allowing another relative with good English to participate alongside the young person (if they wish it). 5. Participation in behavioural weight management programmes in the past 12 months. This does not include participation in commercial programmes such as Weight Watchers. 6. Young people with BMI greater than or equal to 45 kg/m2. We exclude this group as the evidence suggests they are unlikely to benefit from a community based intervention such as HELP. Previous exclusion criteria until 13/07/2012: 6. Young people with BMI greater than or equal to 40 kg/m2. We exclude this group as the evidence suggests they are unlikely to benefit from a community based intervention such as HELP.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMI (kg/m2), measured at 0, 13, 26, 52 weeks (follow-up assessment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 06/10/2015: 1. Health-related quality of life (HR-QOL) assessed using one measure: An obesity-specific QOL instrument. The Impact of Weight on Quality of Life (IWQOL)-Kids is a 27-item instrument consisting of four scales: physical comfort (six items), body esteem (nine items), social life (six items), and family relations (six items). It has excellent psychometric properties (0, 26, 52 weeks) 2. Anthropometric measures (0, 13, 26, 52 weeks) 3. Psychological factors: Assess the impact of the intervention on psychological function and enable examination of pathways by which the intervention may influence QOL and BMI change (0, 26, 52 weeks) 4. Lifestyle (0, 26, 52 weeks) 5. Cardiometabolic risk factors (0, 26 weeks) 6. Health economic assessment data (0, 13, 26, 52 weeks) Previous secondary outcome measures: 1. Health-related quality of life (HR-QOL) assessed using two measures (0, 26, 52 weeks) 2. Anthropometric measures (0, 13, 26, 52 weeks) 3. Psychological factors: Assess the impact of the intervention on psychological function and enable examination of pathways by which the intervention may influence QOL and BMI change (0, 26, 52 weeks) 4. Lifestyle (0, 26, 52 weeks) 5. Cardiometabolic risk factors (0, 26 weeks) 6. Health economic assessment data (0, 13, 26, 52 weeks) | — |
Countries
United Kingdom