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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MMM
Health and Nutrition Education
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

7 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

multi-component, multi-level, multi-setting (MMM)

Health and Nutrition Education

Arm Description

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.

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"

Outcomes

Primary Outcome Measures

body mass index trajectory (change)
slope of measured weight in kilograms divided by the square of height in meters

Secondary Outcome Measures

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

Full Information

First Posted
July 10, 2012
Last Updated
April 28, 2021
Sponsor
Stanford University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01642836
Brief Title
Clinic, Family & Community Intervention for Children With Overweight and Obesity (Stanford GOALS)
Official Title
Clinic, Family & Community Collaboration to Treat Overweight and Obese Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 13, 2012 (Actual)
Primary Completion Date
December 19, 2016 (Actual)
Study Completion Date
December 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. 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?
Detailed Description
Single-blind study with all outcomes assessors (data collectors) and Investigators masked (blinded) to intervention assignment. Intention-to-treat analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas N Robinson, MD, MPH
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://biolincc.nhlbi.nih.gov/studies/?q=coptr
Citations:
PubMed Identifier
24028942
Citation
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.
Results Reference
background
PubMed Identifier
33933181
Citation
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.
Results Reference
derived
PubMed Identifier
32909523
Citation
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.
Results Reference
derived
PubMed Identifier
32153951
Citation
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.
Results Reference
derived
PubMed Identifier
31138278
Citation
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.
Results Reference
derived

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

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