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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Health and Nutrition Education; Behavioral: MMM

• Registration Number: NCT01642836
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2012-07-10
• Study First Submitted QC: 2012-07-12
• Study Start: 2012-07-13
• Study First Posted: 2012-07-17
• Primary Completion: 2016-12-19
• Study Completion: 2016-12-19
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health and Nutrition Education	Health and Nutrition Education	Enhanced standard care/health and nutrition education intervention: 1. notification of primary care providers about metabolic measures and blood pressure 2. 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"
multi-component, multi-level, multi-setting (MMM)	MMM	1. a theory-based community team sports program designed specifically for overweight and obese children, 2. 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 3. a primary care provider behavioral counseling intervention linked to the community and home interventions.

Primary Outcome Measures

Name	Time	Method
body mass index trajectory (change)	baseline, 1, 2 and 3 years	slope of measured weight in kilograms divided by the square of height in meters

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States