Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas Robinson, Stanford University
ClinicalTrials.gov Identifier:
NCT01221220
First received: October 13, 2010
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Obesity
Behavioral: Standard Packard Pediatric Weight Control Program
Behavioral: Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changes
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Body Mass Index (BMI) [ Time Frame: 18 months post randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Waist Circumference [ Time Frame: 6 months and 18 months post randomization ] [ Designated as safety issue: No ]
  • Triceps skinfold [ Time Frame: 6 months and 18 months post randomization ] [ Designated as safety issue: No ]
  • Resting heart rate [ Time Frame: 6 months and 18 months post randomization ] [ Designated as safety issue: No ]
  • Dietary intake/ meals eaten with television [ Time Frame: 6 months and 18 months post randomization ] [ Designated as safety issue: No ]
  • Weight concerns [ Time Frame: 6 months and 18 months post randomization ] [ Designated as safety issue: No ]
  • Depressive symptoms [ Time Frame: 6 months and 18 months post randomization ] [ Designated as safety issue: No ]
  • Daily energy intake [ Time Frame: 6 months and 18 months post randomization ] [ Designated as safety issue: No ]
  • Physical Activity [ Time Frame: 6 months and 18 months post randomization ] [ Designated as safety issue: No ]
  • Systolic and diastolic blood pressure [ Time Frame: 6 months and 18 months post randomization ] [ Designated as safety issue: No ]
  • Fasting blood lipids, insulin/glucose metabolism [ Time Frame: 6 months and 18 months post randomization ] [ Designated as safety issue: No ]
  • Body Mass Index (BMI) [ Time Frame: 6 months post randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: September 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221220

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Thomas Robinson Stanford University
  More Information

No publications provided

Responsible Party: Thomas Robinson, Irving Schulman, MD Endowed Professor in Child Health; Professor of Pediatrics and of Medicine and CHP/PCOR Associate, Stanford University
ClinicalTrials.gov Identifier: NCT01221220     History of Changes
Other Study ID Numbers: SU-08302010-6809, R01HL096015
Study First Received: October 13, 2010
Last Updated: January 23, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 20, 2014