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

NCT01642836 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2021-05-03

No results posted yet for this study

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?

Conditions

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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"

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Stanford University

    lead OTHER

Principal Investigators

  • Thomas N Robinson, MD, MPH · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-13
Primary Completion
2016-12-19
Completion
2016-12-19

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01642836 on ClinicalTrials.gov