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

Stanford University

Status: Completed

Conditions: Obesity

Treatments: Behavioral: MMM; Behavioral: Health and Nutrition Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01642836

U01HL103629 (U.S. NIH Grant/Contract)

19311

Details and patient eligibility

About

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?

Full description

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

Enrollment: 241 patients

Sex: All

Ages: 7 to 11 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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241 participants in 2 patient groups

multi-component, multi-level, multi-setting (MMM)

Experimental group

Description:

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.

Treatment:

Behavioral: MMM

Health and Nutrition Education

Active Comparator group

Description:

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"

Treatment:

Behavioral: Health and Nutrition Education