Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children
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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 |
- Body Mass Index (BMI) [ Time Frame: 18 months post randomization ] [ Designated as safety issue: No ]
- 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 |
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:
- 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);
- are taking medications affecting growth (systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone);
- 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);
- 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);
- are unable to read, understand or complete informed consent in English or Spanish;
- plan to move from the San Francisco Bay Area within the next 18 months.
Contacts and Locations| Contact: Donna Matheson, PhD | (650) 498-4765 | matheson@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Donna Matheson, PhD 650-498-4765 matheson@stanford.edu | |
| Contact: Sally McCarthy (650) 723-5895 smccarthy@stanford.edu | |
| Sub-Investigator: Donna Matheson | |
| Sub-Investigator: Joel D Killen | |
| Principal Investigator: Thomas Robinson | |
| 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: | July 13, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hyperphagia Obesity Signs and Symptoms, Digestive Signs and Symptoms |
Overnutrition Nutrition Disorders Overweight Body Weight |
ClinicalTrials.gov processed this record on May 19, 2013