Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children

NCT ID: NCT01221220

Last Updated: 2021-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-10-15

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Behavioral Treatment

Six-month, family-based, group, behavioral weight control program

Group Type: ACTIVE_COMPARATOR

Standard Packard Pediatric Weight Control Program

Intervention Type: BEHAVIORAL

Six-month, family-based, group, behavioral weight control program

Behavioral Treatment plus Environmental Strategies

Six-month, family-based, group, behavioral weight control program plus home-based environmental intervention

Group Type: EXPERIMENTAL

Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changes

Intervention Type: BEHAVIORAL

Six-month, family-based, group, behavioral weight control program plus Home-based Environmental strategies intervention

Interventions

Standard Packard Pediatric Weight Control Program

Six-month, family-based, group, behavioral weight control program

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Thomas Robinson

Irving Schulman, MD Endowed Professor in Child Health; Professor of Pediatrics and of Medicine and CHP/PCOR Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Robinson

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

R01HL096015

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SU-08302010-6809

Identifier Type: -

Identifier Source: org_study_id