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

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ClinicalTrials.gov Identifier: NCT01642836
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : May 3, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Thomas Robinson, Stanford University

Brief 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?

Condition or disease Intervention/treatment Phase
Obesity Behavioral: MMM Behavioral: Health and Nutrition Education Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
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
Actual Study Start Date : July 13, 2012
Actual Primary Completion Date : December 19, 2016
Actual Study Completion Date : December 19, 2016

Arm Intervention/treatment
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"




Primary Outcome Measures :
  1. body mass index trajectory (change) [ Time Frame: baseline, 1, 2 and 3 years ]
    slope of measured weight in kilograms divided by the square of height in meters


Secondary Outcome Measures :
  1. waist circumference [ Time Frame: baseline, 1, 2 and 3 years ]
    waist circumference in centimeters

  2. triceps skinfold thickness [ Time Frame: baseline, 1, 2 and 3 years ]
    triceps skinfold thickness in mm

  3. Percent median BMI for age and sex (calculated from BMI) [ Time Frame: baseline, 1, 2, and 3 years ]
    age- and sex-adjusted BMI

  4. Waist-to-Height Ratio [ Time Frame: baseline, 1, 2 and 3 years ]
    calculated from waist and height measures

  5. Percent body fat (estimated) [ Time Frame: baseline, 1, 2, and 3 years ]
    Estimated from regression equation

  6. fasting Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Insulin, glucose, hemoglobin A1c, high sensitivity C-Reactive Protein, Alanine Aminotransferase (ALT) [ Time Frame: baseline, 1, 2 and 3 years ]
    lab assays of fasting samples

  7. resting blood pressure [ Time Frame: baseline, 1, 2 and 3 years ]
    automated resting blood pressure

  8. resting heart rate [ Time Frame: baseline, 1, 2 and 3 years ]
    automated pulse

  9. physical activity measured by accelerometry [ Time Frame: baseline, 1, 2 and 3 years ]
    Actigraph model GT3X+ total and after school physical activity and sedentary behavior

  10. 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

  11. Typical household Television (TV) use [ Time Frame: baseline, 1, 2, and 3 years ]
    Constant TV household measure

  12. Average total daily energy intake [ Time Frame: baseline, 1, 2 and 3 years ]
    from 24 hour diet recalls

  13. Percent of energy intake from fat [ Time Frame: baseline, 1, 2, and 3 years ]
    from 24 hour diet recalls

  14. Added sugar [ Time Frame: baseline, 1, 2, and 3 years ]
    from 24 hour diet recalls

  15. Eating with screens [ Time Frame: baseline, 1, 2, and 3 years ]
    breakfast, dinner and energy (from 24-hour diet recalls)

  16. Depressive symptoms [ Time Frame: baseline, 1, 2 and 3 years ]
    Children's Depression Index short form

  17. Weight Concerns [ Time Frame: baseline, 1, 2 and 3 years ]
    Overconcern with weight and shape scale

  18. School performance [ Time Frame: baseline, 1, 2 and 3 years ]
    parent/guardian reported grades

  19. Children's sleep habits [ Time Frame: baseline, 1, 2 and 3 years ]
    parent/guardian reported

  20. Implicit theories [ Time Frame: baseline, 1, 2, and 3 years ]
    fixed versus growth mindset

  21. Parent/guardian weight [ Time Frame: baseline, 1, 2, and 3 years ]
    measured weight

  22. Parent/guardian body mass index [ Time Frame: baseline, 1, 2, and 3 years ]
    calculated from measures of height and weight

  23. Parent/guardian waist circumference [ Time Frame: baseline, 1, 2, and 3 years ]
    waist circumference measured in cm

  24. Parent/guardian reported physical activity [ Time Frame: baseline, 1, 2, and 3 years ]
    survey

  25. Parent/guardian health literacy [ Time Frame: baseline, 1 and 2 years ]
    New Vital Sign (NVS) measure



Information from the National Library of Medicine

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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 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.

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
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Thomas N Robinson, MD, MPH Stanford University
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Robinson, Professor of Pediatrics and of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01642836    
Other Study ID Numbers: 19311
U01HL103629 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Investigators can request the limited public access data set from the National Heart, Lung, and Blood Institute Biologic Specimen and Data Repository Information Coordinating Center
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data currently available
Access Criteria: Investigators can request the limited public access data set from the National Heart, Lung, and Blood Institute Biologic Specimen and Data Repository Information Coordinating Center at https://biolincc.nhlbi.nih.gov/studies/?q=coptr
URL: https://biolincc.nhlbi.nih.gov/studies/?q=coptr
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight