Trial name or title | Clinic family & community collaboration to treat overweight and obese children (Stanford GOALS) |
Methods | Study design: Randomised controlled trial Blinding:
Duration of intervention: 3 years Follow‐up measurements: After 1, 2 and 3 years Unit of allocation: School Unit of analysis: Child Inclusion criteria: Children 7 ‐ 11 years of age, BMI ≥ 85th percentile for age and gender on the 2000 CDC BMI reference Exclusion criteria: Child diagnosed with a medical condition affecting growth (e.g. type 1 diabetes, chronic gastrointestinal disease, chronic renal disease, heart condition); pregnancy; taking type 2 diabetes medication; taking medication affecting growth; with conditions limiting participation in the intervention (e.g. physical disability) and assessment (e.g. insufficient English or Spanish reading and writing competency); unable to understand and complete consent forms; intention to move from San Francisco Bay Area within the next 36 months Sample size calculation: Not reported |
Participants | Estimated N: 240 Age: 7 to 11 years Geographical region: California, USA |
Interventions |
Intervention: Large‐scale, community‐based, interdisciplinary, multicomponent, multisetting intervention
Standard care: Health and nutrition education; semi‐annual home counselling visits, monthly health education newsletter for children and parents/carers, quarterly community‐based evening health lectures |
Outcomes |
School achievement: No details reported Obesity indices: Body mass index, waist circumference, triceps skinfold thickness, waist‐to‐hip ratio; no further details provided |
Starting date | July 2012 |
Contact information | Dr Donna Matheson, donna.matheson@stanford.edu, Stanford University, Palo Alto, California, United States 94304 |
Notes | Estimated completion date: April 2017 Trial registration: NCT01642836 (clinicaltrials.gov/ct2/show/NCT01642836) |