Back to resultsEnvironmental Strategies & Behavior Change to Reduce Overeating in Obese Children
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Packard Pediatric Weight Control Program
Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changes
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility 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:
- 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.
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Behavioral Treatment
Behavioral Treatment plus Environmental Strategies
Arm Description
Six-month, family-based, group, behavioral weight control program
Six-month, family-based, group, behavioral weight control program plus home-based environmental intervention
Outcomes
Primary Outcome Measures
Body Mass Index (BMI)
Secondary Outcome Measures
Waist Circumference
Triceps skinfold
Resting heart rate
Dietary intake/ meals eaten with television
Weight concerns
Depressive symptoms
Daily energy intake
Physical Activity
Systolic and diastolic blood pressure
Fasting blood lipids, insulin/glucose metabolism
Body Mass Index (BMI)
Full Information
NCT ID
NCT01221220
First Posted
October 13, 2010
Last Updated
May 4, 2021
Sponsor
Stanford University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01221220
Brief Title
Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children
Official Title
Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 15, 2014 (Actual)
Study Completion Date
October 15, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Treatment
Arm Type
Active Comparator
Arm Description
Six-month, family-based, group, behavioral weight control program
Arm Title
Behavioral Treatment plus Environmental Strategies
Arm Type
Experimental
Arm Description
Six-month, family-based, group, behavioral weight control program plus home-based environmental intervention
Intervention Type
Behavioral
Intervention Name(s)
Standard Packard Pediatric Weight Control Program
Intervention Description
Six-month, family-based, group, behavioral weight control program
Intervention Type
Behavioral
Intervention Name(s)
Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changes
Intervention Description
Six-month, family-based, group, behavioral weight control program plus Home-based Environmental strategies intervention
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Time Frame
18 months post randomization
Secondary Outcome Measure Information:
Title
Waist Circumference
Time Frame
6 months and 18 months post randomization
Title
Triceps skinfold
Time Frame
6 months and 18 months post randomization
Title
Resting heart rate
Time Frame
6 months and 18 months post randomization
Title
Dietary intake/ meals eaten with television
Time Frame
6 months and 18 months post randomization
Title
Weight concerns
Time Frame
6 months and 18 months post randomization
Title
Depressive symptoms
Time Frame
6 months and 18 months post randomization
Title
Daily energy intake
Time Frame
6 months and 18 months post randomization
Title
Physical Activity
Time Frame
6 months and 18 months post randomization
Title
Systolic and diastolic blood pressure
Time Frame
6 months and 18 months post randomization
Title
Fasting blood lipids, insulin/glucose metabolism
Time Frame
6 months and 18 months post randomization
Title
Body Mass Index (BMI)
Time Frame
6 months post randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Robinson
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
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Environmental Strategies & Behavior Change to Reduce Overeating in Obese Children
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