Clinic, Family & Community Collaboration to Treat Overweight and Obese Children (Stanford GOALS)
Status: | Recruiting |
---|---|
Conditions: | Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 7 - 11 |
Updated: | 1/1/2014 |
Start Date: | July 2012 |
End Date: | April 2017 |
Contact: | Donna Matheson, PhD |
Email: | donna.matheson@stanford.edu |
Phone: | (650) 724-5790 |
Clinic, Family & Community Collaboration to Treat Overweight and Obese Children
Stanford Goals is a large-scale, community-based randomized controlled trial of an
innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) approach to
treating overweight and obese children. Primary Research Question: Will a 3-year,
innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM)
community-based intervention to treat overweight and obese children significantly reduce BMI
compared to an enhanced standard care/health and nutrition education active comparison
intervention?
innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) approach to
treating overweight and obese children. Primary Research Question: Will a 3-year,
innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM)
community-based intervention to treat overweight and obese children significantly reduce BMI
compared to an enhanced standard care/health and nutrition education active comparison
intervention?
Single-blind study with all outcomes assessors (data collectors) and Investigators masked
(blinded) to intervention assignment. Intention-to-treat analysis.
(blinded) to intervention assignment. Intention-to-treat analysis.
Inclusion Criteria:
- 7-11 years of age
- BMI greater than or equal to the 85th percentile for age and sex on the 2000 CDC BMI
reference
Exclusion Criteria:
- Have been diagnosed with a medical condition affecting growth (a genetic or metabolic
disease/syndrome associated with obesity, Type 1 diabetes, Type 2 diabetes taking
medication, chronic gastrointestinal diseases, Chronic renal diseases, uncorrected
structural heart disease, heart failure, heart transplant, anorexia nervosa or
bulimia nervosa or binge eating disorder (present or past), AIDS or HIV infection,
pregnancy);
- Take medications affecting growth (systemic corticosteroids more than 2 weeks in the
past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone);
- Have a condition limiting their participation in the interventions (e.g., unable to
participate in routine physical education classes at school, requiring oxygen
supplementation for exertion, developmental or physical disability preventing
participation in interventions, children or parents/guardians who cannot medically
participate in mild dietary restrictions and/or increased physical activity for any
reason);
- Have a condition limiting participation in the assessments (child or primary
caregiver not able to read surveys in English or Spanish, child two or more grade
levels delayed in school for reading and writing in her native language);
- Are unable to read, understand or complete informed consent in English or Spanish;
- Plan to move from the San Francisco Bay Area within the next 36 months.
- Are deemed to have another characteristic that makes them unsuitable for
participation in the study in the judgment of the Principal Investigator.
We found this trial at
1
site
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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