Clinic, Family & Community Intervention for Children With Overweight and Obesity (Stanford GOALS)

Study Overview
=================
Brief Summary
-----------------
Stanford GOALS is a large-scale, community-based randomized controlled trial of an innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) approach to treating overweight and obese children. Primary Research Question: Will a 3-year, innovative, interdisciplinary, multi-component, multi-level, multi-setting (MMM) community-based intervention to treat overweight and obese children significantly reduce BMI compared to an enhanced standard care/health and nutrition education active comparison intervention?

Detailed Description
-----------------
Single-blind study with all outcomes assessors (data collectors) and Investigators masked (blinded) to intervention assignment. Intention-to-treat analysis.

Official Title
-----------------
Clinic, Family & Community Collaboration to Treat Overweight and Obese Children

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: MMM
* Behavioral: Health and Nutrition Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 7-11 years of age BMI greater than or equal to the 85th percentile for age and sex on the 2000 U.S. Centers for Disease Control and Prevention (CDC) BMI reference Exclusion Criteria: Have been diagnosed with a medical condition affecting growth (a genetic or metabolic disease/syndrome associated with 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); Take 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 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 36 months. Are deemed to have another characteristic that makes them unsuitable for participation in the study in the judgment of the Principal Investigator.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multi-component, multi-level, multi-setting (MMM)<br>a theory-based community team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care provider behavioral counseling intervention linked to the community and home interventions. | Behavioral: MMM<br>* a theory-based community team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care provider behavioral counseling intervention linked to the community and home interventions.<br>|
| Active Comparator: Health and Nutrition Education<br>Enhanced standard care/health and nutrition education intervention: notification of primary care providers about metabolic measures and blood pressure state-of-the-art information-based health and nutrition education, including semi-annual home counseling visits, monthly health education newsletters for children and for parents/guardians, and a series of quarterly, community-based evening health lectures and Family Fun Nights | Behavioral: Health and Nutrition Education<br>* Enhanced standard care/health and nutrition education intervention: notification of primary care providers about metabolic measures and blood pressure state-of-the-art information-based health and nutrition education, including semi-annual home counseling visits, monthly health education newsletters for children and for parents/guardians, and a series of quarterly, community-based evening health lectures and Family Fun Nights<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index trajectory (change) | slope of measured weight in kilograms divided by the square of height in meters | baseline, 1, 2 and 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist circumference | waist circumference in centimeters | baseline, 1, 2 and 3 years | 
| triceps skinfold thickness | triceps skinfold thickness in mm | baseline, 1, 2 and 3 years | 
| Percent median BMI for age and sex (calculated from BMI) | age- and sex-adjusted BMI | baseline, 1, 2, and 3 years | 
| Waist-to-Height Ratio | calculated from waist and height measures | baseline, 1, 2 and 3 years | 
| Percent body fat (estimated) | Estimated from regression equation | baseline, 1, 2, and 3 years | 
| fasting Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Insulin, glucose, hemoglobin A1c, high sensitivity C-Reactive Protein, Alanine Aminotransferase (ALT) | lab assays of fasting samples | baseline, 1, 2 and 3 years | 
| resting blood pressure | automated resting blood pressure | baseline, 1, 2 and 3 years | 
| resting heart rate | automated pulse | baseline, 1, 2 and 3 years | 
| physical activity measured by accelerometry | Actigraph model GT3X+ total and after school physical activity and sedentary behavior | baseline, 1, 2 and 3 years | 
| screen time and other sedentary behaviors | self-reported weekday, saturday and sunday, television, movies, video games, computer, portable media devices, mobile phones | baseline, 1, 2 and 3 years | 
| Typical household Television (TV) use | Constant TV household measure | baseline, 1, 2, and 3 years | 
| Average total daily energy intake | from 24 hour diet recalls | baseline, 1, 2 and 3 years | 
| Percent of energy intake from fat | from 24 hour diet recalls | baseline, 1, 2, and 3 years | 
| Added sugar | from 24 hour diet recalls | baseline, 1, 2, and 3 years | 
| Eating with screens | breakfast, dinner and energy (from 24-hour diet recalls) | baseline, 1, 2, and 3 years | 
| Depressive symptoms | Children's Depression Index short form | baseline, 1, 2 and 3 years | 
| Weight Concerns | Overconcern with weight and shape scale | baseline, 1, 2 and 3 years | 
| School performance | parent/guardian reported grades | baseline, 1, 2 and 3 years | 
| Children's sleep habits | parent/guardian reported | baseline, 1, 2 and 3 years | 
| Implicit theories | fixed versus growth mindset | baseline, 1, 2, and 3 years | 
| Parent/guardian weight | measured weight | baseline, 1, 2, and 3 years | 
| Parent/guardian body mass index | calculated from measures of height and weight | baseline, 1, 2, and 3 years | 
| Parent/guardian waist circumference | waist circumference measured in cm | baseline, 1, 2, and 3 years | 
| Parent/guardian reported physical activity | survey | baseline, 1, 2, and 3 years | 
| Parent/guardian health literacy | New Vital Sign (NVS) measure | baseline, 1 and 2 years |