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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT01642836
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
241
1
2
53.2
4.5

Study Details

Study Description

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
  • Behavioral: MMM
  • Behavioral: Health and Nutrition Education
N/A

Detailed Description

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

Study Design

Study Type:
Interventional
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 :
Jul 13, 2012
Actual Primary Completion Date :
Dec 19, 2016
Actual Study Completion Date :
Dec 19, 2016

Arms and Interventions

Arm Intervention/Treatment
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"

Outcome Measures

Primary Outcome Measures

  1. body mass index trajectory (change) [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 [baseline, 1, 2 and 3 years]

    waist circumference in centimeters

  2. triceps skinfold thickness [baseline, 1, 2 and 3 years]

    triceps skinfold thickness in mm

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

    age- and sex-adjusted BMI

  4. Waist-to-Height Ratio [baseline, 1, 2 and 3 years]

    calculated from waist and height measures

  5. Percent body fat (estimated) [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) [baseline, 1, 2 and 3 years]

    lab assays of fasting samples

  7. resting blood pressure [baseline, 1, 2 and 3 years]

    automated resting blood pressure

  8. resting heart rate [baseline, 1, 2 and 3 years]

    automated pulse

  9. physical activity measured by accelerometry [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 [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 [baseline, 1, 2, and 3 years]

    Constant TV household measure

  12. Average total daily energy intake [baseline, 1, 2 and 3 years]

    from 24 hour diet recalls

  13. Percent of energy intake from fat [baseline, 1, 2, and 3 years]

    from 24 hour diet recalls

  14. Added sugar [baseline, 1, 2, and 3 years]

    from 24 hour diet recalls

  15. Eating with screens [baseline, 1, 2, and 3 years]

    breakfast, dinner and energy (from 24-hour diet recalls)

  16. Depressive symptoms [baseline, 1, 2 and 3 years]

    Children's Depression Index short form

  17. Weight Concerns [baseline, 1, 2 and 3 years]

    Overconcern with weight and shape scale

  18. School performance [baseline, 1, 2 and 3 years]

    parent/guardian reported grades

  19. Children's sleep habits [baseline, 1, 2 and 3 years]

    parent/guardian reported

  20. Implicit theories [baseline, 1, 2, and 3 years]

    fixed versus growth mindset

  21. Parent/guardian weight [baseline, 1, 2, and 3 years]

    measured weight

  22. Parent/guardian body mass index [baseline, 1, 2, and 3 years]

    calculated from measures of height and weight

  23. Parent/guardian waist circumference [baseline, 1, 2, and 3 years]

    waist circumference measured in cm

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

    survey

  25. Parent/guardian health literacy [baseline, 1 and 2 years]

    New Vital Sign (NVS) measure

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 11 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Thomas Robinson, Professor of Pediatrics and of Medicine, Stanford University
ClinicalTrials.gov Identifier:
NCT01642836
Other Study ID Numbers:
  • 19311
  • U01HL103629
First Posted:
Jul 17, 2012
Last Update Posted:
May 3, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2021