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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-13

Study Completion Date

2016-12-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Obesity Prevention for Pre-Adolescents

NCT00185978

Cardiovascular Diseases Heart Diseases Obesity

COMPLETED PHASE2

School and Family-Based Obesity Prevention for Children

NCT00005750

Cardiovascular Diseases Heart Diseases Obesity

COMPLETED

Guided Self-help for Families With an Overweight Child

NCT01145833

Obesity

COMPLETED NA

Wise Social Psychological Interventions to Improve Outcomes of Behavioral Weight Control in Children With Obesity

NCT04422951

Obesity, Childhood

TERMINATED NA

Pediatric Obesity Treatment in a Safety Net Clinic: Piloting the Step by Step Program

NCT04297228

Pediatric Obesity Overweight and Obesity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

MMM

Intervention Type BEHAVIORAL

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.

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"

Group Type ACTIVE_COMPARATOR

Health and Nutrition Education

Intervention Type BEHAVIORAL

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"

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 Type 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"

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes