Status:
COMPLETED
Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obesity
Eligibility:
All Genders
8-15 years
Phase:
NA
Brief Summary
There is a need for effective weight control methods for obese children. Environmental strategies such as reducing the size of dishware and serving utensils, storing food out of view and reducing food...
Detailed Description
Single blind study with outcome assessors (data collectors)and investigators masked (blinded) to intervention assignment. Analysis is intention-to-treat.
Eligibility Criteria
Inclusion
- Inclusion criteria: 8-15 year old obese children (BMI \≥ 95th percentile on the 2000 CDC BMI reference) on the date of randomization. Our standard Stanford Pediatric Weight Control Program eligibility criteria will apply: both child and parent/guardian must want to join, both child and at least one parent/guardian must agree to attend sessions, and must agree to not miss more than 2 consecutive sessions. As we interested in testing generalizable strategies for weight control in diverse populations, the eligibility criteria are designed to be liberal, to maximize the generalizability of the results, but also maintain the internal validity of the test of the intervention.
Exclusion
- Exclusions: To enhance internal validity, children will not be eligible if they:
- have been diagnosed with a medical condition affecting growth (a genetic or metabolic disease/syndrome associated 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);
- are taking 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 his/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 18 months.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2014
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT01221220
Start Date
September 1 2010
End Date
October 15 2014
Last Update
May 7 2021
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305