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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01642836
First received: July 10, 2012
Last updated: January 23, 2014
Last verified: January 2014
  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:


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)
  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: 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.
Active Comparator: 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"
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"

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Thomas N Robinson, MD, MPH Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: January 23, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014