Overview

This trial is active, not recruiting.

Condition obesity
Treatments standard packard pediatric weight control program, standard packard pediatric weight control program plus home-based advising on environmental changes
Phase phase 2
Sponsor Stanford University
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date September 2010
End date February 2015
Trial size 160 participants
Trial identifier NCT01221220, R01HL096015, SU-08302010-6809

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Six-month, family-based, group, behavioral weight control program
standard packard pediatric weight control program
Six-month, family-based, group, behavioral weight control program
(Experimental)
Six-month, family-based, group, behavioral weight control program plus home-based environmental intervention
standard packard pediatric weight control program plus home-based advising on environmental changes
Six-month, family-based, group, behavioral weight control program plus Home-based Environmental strategies intervention

Primary Outcomes

Measure
Body Mass Index (BMI)
time frame: 18 months post randomization

Secondary Outcomes

Measure
Waist Circumference
time frame: 6 months and 18 months post randomization
Triceps skinfold
time frame: 6 months and 18 months post randomization
Resting heart rate
time frame: 6 months and 18 months post randomization
Dietary intake/ meals eaten with television
time frame: 6 months and 18 months post randomization
Weight concerns
time frame: 6 months and 18 months post randomization
Depressive symptoms
time frame: 6 months and 18 months post randomization
Daily energy intake
time frame: 6 months and 18 months post randomization
Physical Activity
time frame: 6 months and 18 months post randomization
Systolic and diastolic blood pressure
time frame: 6 months and 18 months post randomization
Fasting blood lipids, insulin/glucose metabolism
time frame: 6 months and 18 months post randomization
Body Mass Index (BMI)
time frame: 6 months post randomization

Eligibility Criteria

Male or female participants from 8 years up to 15 years old.

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.

Additional Information

Official title Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children
Principal investigator Thomas Robinson
Description Single blind study with outcome assessors (data collectors)and investigators masked (blinded) to intervention assignment. Analysis is intention-to-treat.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Stanford University.