Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Standard Packard Pediatric Weight Control Program; Behavioral: Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changes

Detailed Description

Single blind study with outcome assessors (data collectors)and investigators masked (blinded) to intervention assignment. Analysis is intention-to-treat.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Behavioral Treatment; Six-month, family-based, group, behavioral weight control program	Behavioral: Standard Packard Pediatric Weight Control Program; Six-month, family-based, group, behavioral weight control program
Experimental: Behavioral Treatment plus Environmental Strategies; Six-month, family-based, group, behavioral weight control program plus home-based environmental intervention	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body Mass Index (BMI)	18 months post randomization

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Thomas Robinson, Stanford University

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 15, 2014
• Study Completion (Actual): October 15, 2014

Study Registration Dates

• First Submitted: October 13, 2010
• First Submitted That Met QC Criteria: October 13, 2010
• First Posted (Estimate): October 14, 2010

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Hyperphagia
• Other Study ID Numbers: SU-08302010-6809; R01HL096015 (U.S. NIH Grant/Contract)