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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642836
• Other study ID #: 19311
• Secondary ID: U01HL103629
• Status: Completed
• Phase: N/A
• Start date: July 13, 2012
• Est. completion date: December 19, 2016

Study information

• Verified date: April 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: December 19, 2016
• Est. primary completion date: December 19, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.
• 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"

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Robinson TN, Matheson D, Desai M, Wilson DM, Weintraub DL, Haskell WL, McClain A, McClure S, Banda JA, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body mass index trajectory (change)	slope of measured weight in kilograms divided by the square of height in meters	baseline, 1, 2 and 3 years
Secondary	waist circumference	waist circumference in centimeters	baseline, 1, 2 and 3 years
Secondary	triceps skinfold thickness	triceps skinfold thickness in mm	baseline, 1, 2 and 3 years
Secondary	Percent median BMI for age and sex (calculated from BMI)	age- and sex-adjusted BMI	baseline, 1, 2, and 3 years
Secondary	Waist-to-Height Ratio	calculated from waist and height measures	baseline, 1, 2 and 3 years
Secondary	Percent body fat (estimated)	Estimated from regression equation	baseline, 1, 2, and 3 years
Secondary	fasting Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Insulin, glucose, hemoglobin A1c, high sensitivity C-Reactive Protein, Alanine Aminotransferase (ALT)	lab assays of fasting samples	baseline, 1, 2 and 3 years
Secondary	resting blood pressure	automated resting blood pressure	baseline, 1, 2 and 3 years
Secondary	resting heart rate	automated pulse	baseline, 1, 2 and 3 years
Secondary	physical activity measured by accelerometry	Actigraph model GT3X+ total and after school physical activity and sedentary behavior	baseline, 1, 2 and 3 years
Secondary	screen time and other sedentary behaviors	self-reported weekday, saturday and sunday, television, movies, video games, computer, portable media devices, mobile phones	baseline, 1, 2 and 3 years
Secondary	Typical household Television (TV) use	Constant TV household measure	baseline, 1, 2, and 3 years
Secondary	Average total daily energy intake	from 24 hour diet recalls	baseline, 1, 2 and 3 years
Secondary	Percent of energy intake from fat	from 24 hour diet recalls	baseline, 1, 2, and 3 years
Secondary	Added sugar	from 24 hour diet recalls	baseline, 1, 2, and 3 years
Secondary	Eating with screens	breakfast, dinner and energy (from 24-hour diet recalls)	baseline, 1, 2, and 3 years
Secondary	Depressive symptoms	Children's Depression Index short form	baseline, 1, 2 and 3 years
Secondary	Weight Concerns	Overconcern with weight and shape scale	baseline, 1, 2 and 3 years
Secondary	School performance	parent/guardian reported grades	baseline, 1, 2 and 3 years
Secondary	Children's sleep habits	parent/guardian reported	baseline, 1, 2 and 3 years
Secondary	Implicit theories	fixed versus growth mindset	baseline, 1, 2, and 3 years
Secondary	Parent/guardian weight	measured weight	baseline, 1, 2, and 3 years
Secondary	Parent/guardian body mass index	calculated from measures of height and weight	baseline, 1, 2, and 3 years
Secondary	Parent/guardian waist circumference	waist circumference measured in cm	baseline, 1, 2, and 3 years
Secondary	Parent/guardian reported physical activity	survey	baseline, 1, 2, and 3 years
Secondary	Parent/guardian health literacy	New Vital Sign (NVS) measure	baseline, 1 and 2 years