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

April 28, 2021 updated by: Thomas Robinson, Stanford University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
241

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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"
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"

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
body mass index trajectory (change)
Time Frame: baseline, 1, 2 and 3 years
slope of measured weight in kilograms divided by the square of height in meters
baseline, 1, 2 and 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
waist circumference
Time Frame: baseline, 1, 2 and 3 years
waist circumference in centimeters
baseline, 1, 2 and 3 years
triceps skinfold thickness
Time Frame: baseline, 1, 2 and 3 years
triceps skinfold thickness in mm
baseline, 1, 2 and 3 years
Percent median BMI for age and sex (calculated from BMI)
Time Frame: baseline, 1, 2, and 3 years
age- and sex-adjusted BMI
baseline, 1, 2, and 3 years
Waist-to-Height Ratio
Time Frame: baseline, 1, 2 and 3 years
calculated from waist and height measures
baseline, 1, 2 and 3 years
Percent body fat (estimated)
Time Frame: baseline, 1, 2, and 3 years
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)
Time Frame: baseline, 1, 2 and 3 years
lab assays of fasting samples
baseline, 1, 2 and 3 years
resting blood pressure
Time Frame: baseline, 1, 2 and 3 years
automated resting blood pressure
baseline, 1, 2 and 3 years
resting heart rate
Time Frame: baseline, 1, 2 and 3 years
automated pulse
baseline, 1, 2 and 3 years
physical activity measured by accelerometry
Time Frame: baseline, 1, 2 and 3 years
Actigraph model GT3X+ total and after school physical activity and sedentary behavior
baseline, 1, 2 and 3 years
screen time and other sedentary behaviors
Time Frame: baseline, 1, 2 and 3 years
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
Time Frame: baseline, 1, 2, and 3 years
Constant TV household measure
baseline, 1, 2, and 3 years
Average total daily energy intake
Time Frame: baseline, 1, 2 and 3 years
from 24 hour diet recalls
baseline, 1, 2 and 3 years
Percent of energy intake from fat
Time Frame: baseline, 1, 2, and 3 years
from 24 hour diet recalls
baseline, 1, 2, and 3 years
Added sugar
Time Frame: baseline, 1, 2, and 3 years
from 24 hour diet recalls
baseline, 1, 2, and 3 years
Eating with screens
Time Frame: baseline, 1, 2, and 3 years
breakfast, dinner and energy (from 24-hour diet recalls)
baseline, 1, 2, and 3 years
Depressive symptoms
Time Frame: baseline, 1, 2 and 3 years
Children's Depression Index short form
baseline, 1, 2 and 3 years
Weight Concerns
Time Frame: baseline, 1, 2 and 3 years
Overconcern with weight and shape scale
baseline, 1, 2 and 3 years
School performance
Time Frame: baseline, 1, 2 and 3 years
parent/guardian reported grades
baseline, 1, 2 and 3 years
Children's sleep habits
Time Frame: baseline, 1, 2 and 3 years
parent/guardian reported
baseline, 1, 2 and 3 years
Implicit theories
Time Frame: baseline, 1, 2, and 3 years
fixed versus growth mindset
baseline, 1, 2, and 3 years
Parent/guardian weight
Time Frame: baseline, 1, 2, and 3 years
measured weight
baseline, 1, 2, and 3 years
Parent/guardian body mass index
Time Frame: baseline, 1, 2, and 3 years
calculated from measures of height and weight
baseline, 1, 2, and 3 years
Parent/guardian waist circumference
Time Frame: baseline, 1, 2, and 3 years
waist circumference measured in cm
baseline, 1, 2, and 3 years
Parent/guardian reported physical activity
Time Frame: baseline, 1, 2, and 3 years
survey
baseline, 1, 2, and 3 years
Parent/guardian health literacy
Time Frame: baseline, 1 and 2 years
New Vital Sign (NVS) measure
baseline, 1 and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas N Robinson, MD, MPH, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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