Clinical trial NCT01221220: Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children
Official title: Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-10-14
Enrollment: 174
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 Criteria:Inclusion criteria: 8-15 year old obese children (BMI \&#8805; 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.

Primary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 18 months post randomization
Secondary outcomes:
measure: Waist Circumference
timeFrame: 6 months and 18 months post randomization
measure: Triceps skinfold
timeFrame: 6 months and 18 months post randomization
measure: Resting heart rate
timeFrame: 6 months and 18 months post randomization
measure: Dietary intake/ meals eaten with television
timeFrame: 6 months and 18 months post randomization
measure: Weight concerns
timeFrame: 6 months and 18 months post randomization
measure: Depressive symptoms
timeFrame: 6 months and 18 months post randomization
measure: Daily energy intake
timeFrame: 6 months and 18 months post randomization
measure: Physical Activity
timeFrame: 6 months and 18 months post randomization
measure: Systolic and diastolic blood pressure
timeFrame: 6 months and 18 months post randomization
measure: Fasting blood lipids, insulin/glucose metabolism
timeFrame: 6 months and 18 months post randomization
measure: Body Mass Index (BMI)
timeFrame: 6 months post randomization
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Thomas Robinson
role: PRINCIPAL_INVESTIGATOR
References: