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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Stanford University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01642836
First Posted: July 17, 2012
Last Update Posted: January 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Stanford University
  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
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinic, Family & Community Collaboration to Treat Overweight and Obese Children

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • body mass index trajectory (change) [ Time Frame: baseline, 1, 2 and 3 years ]

Secondary Outcome Measures:
  • physical activity measured by accelerometry [ Time Frame: baseline, 1, 2 and 3 years ]
  • waist circumference [ Time Frame: baseline, 1, 2 and 3 years ]
  • triceps skinfold thickness [ Time Frame: baseline, 1, 2 and 3 years ]
  • resting blood pressure [ Time Frame: baseline, 1, 2 and 3 years ]
  • resting heart rate [ Time Frame: baseline, 1, 2 and 3 years ]
  • 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 ]
  • screen time and other sedentary behaviors [ Time Frame: baseline, 1, 2 and 3 years ]
    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 ]
  • Waist-to-Height Ratio [ Time Frame: baseline, 1, 2 and 3 years ]
  • Weight Concerns [ Time Frame: baseline, 1, 2 and 3 years ]
  • Depressive symptoms [ Time Frame: baseline, 1, 2 and 3 years ]
  • School performance [ Time Frame: baseline, 1, 2 and 3 years ]
    parent/guardian reported grades

  • Children's sleep habits [ Time Frame: baseline, 1, 2 and 3 years ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01642836


Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Thomas N Robinson, MD, MPH Stanford University
  More Information

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 ( U.S. NIH Grant/Contract )
First Submitted: July 10, 2012
First Posted: July 17, 2012
Last Update Posted: January 27, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms