Clinic, Family & Community Collaboration to Treat Overweight and Obese Children (Stanford GOALS) - Full Text View

Purpose

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?

Condition	Intervention	Phase
Obesity	Behavioral: MMM Behavioral: Health and Nutrition Education	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Clinic, Family & Community Collaboration to Treat Overweight and Obese Children

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

body mass index trajectory (change) [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

physical activity measured by accelerometry [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]
waist circumference [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]
triceps skinfold thickness [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]
resting blood pressure [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]
resting heart rate [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]
fasting Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Insulin, glucose, hemoglobin A1c, high sensitivity C-Reactive Protein, ALT [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]
screen time and other sedentary behaviors [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]
self-reported weekday, saturday and sunday, television, movies, video games, computer, portable media devices, mobile phones
Average total daily energy intake [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]
Waist-to-Height Ratio [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]
Weight Concerns [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]
Depressive symptoms [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]
School performance [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]
parent/guardian reported grades
Children's sleep habits [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	July 2012
Estimated Study Completion Date:	April 2017
Estimated Primary Completion Date:	January 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: multi-component, multi-level, multi-setting (MMM) 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 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.
Active Comparator: Health and Nutrition Education 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 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"

Arms

Assigned Interventions

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

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

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.

Active Comparator: Health and Nutrition Education

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

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"

Detailed Description:

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

Eligibility

Ages Eligible for Study:	7 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

7-11 years of age
BMI greater than or equal to the 85th percentile for age and sex on the 2000 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642836

Contacts

Contact: Donna Matheson, PhD

(650) 724-5790

donna.matheson@stanford.edu

Locations

United States, California
Stanford University	Recruiting
Palo Alto, California, United States, 94304
Contact: Donna Matheson, PhD 650-724-5790 donna.matheson@stanford.edu
Principal Investigator: Thomas N Robinson, MD, MPH

Sponsors and Collaborators

Stanford University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Thomas N Robinson, MD, MPH

Stanford University

More Information

No publications provided

Responsible Party:	Stanford University
ClinicalTrials.gov Identifier:	NCT01642836 History of Changes
Other Study ID Numbers:	spo47512, U01HL103629
Study First Received:	July 10, 2012
Last Updated:	July 16, 2012
Health Authority:	United States: Data and Safety Monitoring Board United States: Institutional Review Board United States: Federal Government

Additional relevant MeSH terms:

Obesity
Overweight
Overnutrition

Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013