Topic: Primary Care Research Network for England
Conditions
Interventions
640 parent-child pairs will be randomised on a 1:1 ratio to either the control (weight managment programme alone) or intervention (weight management programme plus Mandolean) arm.
1. Control arm: Wei
Study Entry : Single Randomisation only
Sponsors
University of Bristol (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Obese children aged 5 - 11 years with a BMI >/= 95th percentile
Exclusion criteria
Exclusion criteria: Children whose weight management requires secondary care consultation as the intervention under investigation is focused on management in primary care. Exclusion criteria will be identified by the referring GP using a standardised checklist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Child BMI standard deviation scores (SDS); Timepoint(s): 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adult eating rate; Timepoint(s): 12 & 24 months 2. Child BMI SDS; Timepoint(s): 24 months 3. Child eating rate; Timepoint(s): 12 & 24 months 4. Child ideal portion size choice; Timepoint(s): 12 & 24 months 5. Child self determined portion size; Timepoint(s): 12 & 24 months 6. Child Health Utility Index 9D (CHU9D); Timepoint(s): 3, 6, 9, 12 & 24 months 7. EQ5D; Timepoint(s): 3, 6, 9, 12 & 24 months 8. EQ5D-Y; Timepoint(s): 3, 6, 9, 12 & 24 months 9. Parent BMI; Timepoint(s): 12 & 24 months 10. Parent ideal portion size choice; Timepoint(s): 12 and 24 months 11. Parent self determined portion size; Timepoint(s): 12 and 24 months 12. PedsQL; Timepoint(s): 12 & 24 months | — |
Countries
United Kingdom
Outcome results
None listed