View Clinical Trial (Medical Research Study)
Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children
| City: |
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Stanford |
| State: |
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California |
| Zip Code: |
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94305 |
| Conditions: |
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Obesity |
| Purpose: |
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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 consumption while watching television may reduce food intake without
requiring conscious, cognitive self-control. The investigators propose to test these methods
when added to a current state-of-the-art behavioral program.
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| Study Summary: |
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Single blind study with outcome assessors (data collectors)and investigators masked
(blinded) to intervention assignment. Analysis is intention-to-treat.
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| Criteria: |
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Inclusion Criteria: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 Criteria:Exclusions: To enhance internal validity, children will not be eligible
if they:
1. 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);
2. are taking medications affecting growth (systemic corticosteroids more than 2 weeks
in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone);
3. 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);
4. 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);
5. are unable to read, understand or complete informed consent in English or Spanish;
6. plan to move from the San Francisco Bay Area within the next 18 months.
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| NCT ID: |
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NCT01221220 |
| Primary Contact: |
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Principal Investigator
Thomas Robinson
Stanford University
Donna Matheson, PhD
Phone: (650) 498-4765
Email: matheson@stanford.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Stanford, California 94305
United States
Donna Matheson, PhD
Phone: 650-498-4765
Email: matheson@stanford.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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