Clinic, Family & Community Intervention for Children With Overweight and Obesity (Stanford GOALS)

Not Recruiting

Trial ID: NCT01642836

Purpose

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?

Official Title

Clinic, Family & Community Collaboration to Treat Overweight and Obese Children

Stanford Investigator(s)

Eligibility


Inclusion Criteria:

   - 7-11 years of age

   - BMI greater than or equal to the 85th percentile for age and sex on the 2000 U.S.
   Centers for Disease Control and Prevention (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.

Intervention(s):

behavioral: MMM

behavioral: Health and Nutrition Education

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Donna Matheson, PhD
650-724-5790