Clinic, Family & Community Intervention for Children With Overweight and Obesity (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?

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: MMM; Behavioral: Health and Nutrition Education

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
waist circumference	waist circumference in centimeters	baseline, 1, 2 and 3 years
triceps skinfold thickness	triceps skinfold thickness in mm	baseline, 1, 2 and 3 years
Percent median BMI for age and sex (calculated from BMI)	age- and sex-adjusted BMI	baseline, 1, 2, and 3 years
Waist-to-Height Ratio	calculated from waist and height measures	baseline, 1, 2 and 3 years
Percent body fat (estimated)	Estimated from regression equation	baseline, 1, 2, and 3 years
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
resting blood pressure	automated resting blood pressure	baseline, 1, 2 and 3 years
resting heart rate	automated pulse	baseline, 1, 2 and 3 years
physical activity measured by accelerometry	Actigraph model GT3X+ total and after school physical activity and sedentary behavior	baseline, 1, 2 and 3 years
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
Typical household Television (TV) use	Constant TV household measure	baseline, 1, 2, and 3 years
Average total daily energy intake	from 24 hour diet recalls	baseline, 1, 2 and 3 years
Percent of energy intake from fat	from 24 hour diet recalls	baseline, 1, 2, and 3 years
Added sugar	from 24 hour diet recalls	baseline, 1, 2, and 3 years
Eating with screens	breakfast, dinner and energy (from 24-hour diet recalls)	baseline, 1, 2, and 3 years
Depressive symptoms	Children's Depression Index short form	baseline, 1, 2 and 3 years
Weight Concerns	Overconcern with weight and shape scale	baseline, 1, 2 and 3 years
School performance	parent/guardian reported grades	baseline, 1, 2 and 3 years
Children's sleep habits	parent/guardian reported	baseline, 1, 2 and 3 years
Implicit theories	fixed versus growth mindset	baseline, 1, 2, and 3 years
Parent/guardian weight	measured weight	baseline, 1, 2, and 3 years
Parent/guardian body mass index	calculated from measures of height and weight	baseline, 1, 2, and 3 years
Parent/guardian waist circumference	waist circumference measured in cm	baseline, 1, 2, and 3 years
Parent/guardian reported physical activity	survey	baseline, 1, 2, and 3 years
Parent/guardian health literacy	New Vital Sign (NVS) measure	baseline, 1 and 2 years

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Thomas N Robinson, MD, MPH, Stanford University

Publications and helpful links

General Publications

• JaKa MM, Wood C, Veblen-Mortenson S, Moore SM, Matheson D, Stevens J, Atkins L, Michie S, Adegbite-Adeniyi C, Olayinka O, Po'e EK, Kelly AM, Nicastro H, Bangdiwala SI, Barkin SL, Pratt C, Robinson TN, Sherwood NE. Applying the Behavior Change Technique Taxonomy to Four Multicomponent Childhood Obesity Interventions. West J Nurs Res. 2021 May;43(5):468-477. doi: 10.1177/0193945920954782. Epub 2020 Sep 10.
• Truesdale KP, Matheson DM, JaKa MM, McAleer S, Sommer EC, Pratt CA. Baseline diet quality of predominantly minority children and adolescents from households characterized by low socioeconomic status in the Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. BMC Nutr. 2019 Sep 9;5:38. doi: 10.1186/s40795-019-0302-y. eCollection 2019.
• Cui Z, Truesdale KP, Robinson TN, Pemberton V, French SA, Escarfuller J, Casey TL, Hotop AM, Matheson D, Pratt CA, Lotas LJ, Po'e E, Andrisin S, Ward DS. Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. Trials. 2019 May 28;20(1):296. doi: 10.1186/s13063-019-3418-0.
• 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.
• Robinson TN, Matheson D, Wilson DM, Weintraub DL, Banda JA, McClain A, Sanders LM, Haskell WL, Haydel KF, Kapphahn KI, Pratt C, Truesdale KP, Stevens J, Desai M. A community-based, multi-level, multi-setting, multi-component intervention to reduce weight gain among low socioeconomic status Latinx children with overweight or obesity: The Stanford GOALS randomised controlled trial. Lancet Diabetes Endocrinol. 2021 Jun;9(6):336-349. doi: 10.1016/S2213-8587(21)00084-X. Epub 2021 Apr 29.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2012
• Primary Completion (Actual): December 19, 2016
• Study Completion (Actual): December 19, 2016

Study Registration Dates

• First Submitted: July 10, 2012
• First Submitted That Met QC Criteria: July 12, 2012
• First Posted (Estimate): July 17, 2012

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: 19311; U01HL103629 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Time Frame: Data currently available
• IPD Sharing 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)