Prevention of obesity in children Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The target population for the intervention are parents of preschool children; mothers, fathers and other carers (e.g. with children living in stable/long-term foster care). Parents may not be registered more than once but they may be screened on more than one occasion if not registered following the first screening, as both eligibility and willingness to participate may change. 2. Parents must have at least one child aged 6 months to 5 years (18 months to 6 years at 12-month follow-up). If more than one child in the family fulfils eligibility criteria, the youngest child (by birth timing if twins) will be considered as the reference child (from which data will be collected). 3. Parents must be willing to attend the programme sessions (intervention centres) and willing to provide data in accordance with the data collection protocol. Parents will be provided with full details of the data collection requirements in advance so that they can make informed decisions as to whether to participate. 4. Parents must speak English unless they wish to bring their own interpreter with them (e.g. family member) (the intervention and data collection forms are currently only available in English).
Exclusion criteria
Exclusion criteria: 1. Parents with severe learning difficulties that preclude them from taking part in group sessions in which they need to be able to read and write, judged on a case-by-case basis with consultation with the HENRY team where appropriate. 2. Parents whose reference child is tube fed (PEG or nasogastric) or with other known clinical conditions likely to affect growth over the period of the trial (e.g. cancer, coeliac disease, or renal or cardiac problems). A detailed list of excluded conditions will be provided at screening, with any uncertainties resolved via clinical input from the HENRY team. 3. Parents who have attended a HENRY group for a previous child
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Child age and gender-adjusted BMI measured using height and weight measurement at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Parent self-efficacy measured using Dumka Parenting Self-Agency Measure (PSAM) at 12 months 2. Family eating behaviours measured using the Golan Family Eating and Activity Questionnaire at 12 months 3. Feeding behaviours measured using the Baughcum pre-school feeding questionnaire at 12 months 4. Dental health measured via a bespoke questionnaire at 12 months 5. Obesity in parents and staff measured using BMI and waist circumference at 12 months 6. Children's centre environment measured using a bespoke environmental questionnaire at 12 months 7. Safety (related unexpected serious adverse event [RUSAE]) measured via case report form (CRF) safety form measured throughout the trial 8. Parent quality of life measured via EQ-5D-5L at 12 months 9. Long-term effects on obesity (including siblings) measured using routine National Child Measurement Programme (NCMP) data at 3 years 10. Attendance at HENRY measured using attendance register completed for each session/programme 11. Contamination measured via staff movement between centres during the trial | — |
Countries
United Kingdom