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Completed

NCT Number: NCT01642836

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

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?

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Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MMM

Behavioral
  • 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.

Health and Nutrition Education

Behavioral

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"

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

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

Registry information

Official study title

Clinic, Family & Community Collaboration to Treat Overweight and Obese Children

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 17, 2012
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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