Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children

Obesity Clinical Trial

Official title:

Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221220
• Other study ID #: SU-08302010-6809
• Secondary ID: R01HL096015
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: October 15, 2014

Study information

• Verified date: May 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: October 15, 2014
• Est. primary completion date: October 15, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperphagia
• Obesity

Intervention

Behavioral:
• Standard Packard Pediatric Weight Control Program
Six-month, family-based, group, behavioral weight control program
• 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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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