Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 10, 2012
January 23, 2014
July 2012
January 2017   (final data collection date for primary outcome measure)
body mass index trajectory (change) [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01642836 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
  • Children's sleep habits [ Time Frame: baseline, 1, 2 and 3 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Clinic, Family & Community Collaboration to Treat Overweight and Obese Children (Stanford GOALS)
Clinic, Family & Community Collaboration to Treat Overweight and Obese Children

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?

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • 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.
  • 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"
  • 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.
    Intervention: Behavioral: MMM
  • 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"
    Intervention: Behavioral: Health and Nutrition Education
Robinson TN, Matheson D, Desai M, Wilson DM, Weintraub DL, Haskell WL, McClain A, McClure S, A Banda J, Sanders LM, Haydel KF, Killen JD. Family, community and clinic collaboration to treat overweight and obese children: Stanford GOALS-A randomized controlled trial of a three-year, multi-component, multi-level, multi-setting intervention. Contemp Clin Trials. 2013 Nov;36(2):421-35. doi: 10.1016/j.cct.2013.09.001. Epub 2013 Sep 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
April 2017
January 2017   (final data collection date for primary outcome measure)

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.
Both
7 Years to 11 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01642836
spo47512, U01HL103629
Yes
Stanford University
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Thomas N Robinson, MD, MPH Stanford University
Stanford University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP