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

NCT01642836 | Completed DMC

• 2 other identifiers: 19311U01HL103629
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

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?

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (25)

• waist circumference

  baseline, 1, 2 and 3 years

• triceps skinfold thickness

  baseline, 1, 2 and 3 years

• Percent median BMI for age and sex (calculated from BMI)

  baseline, 1, 2, and 3 years

• Waist-to-Height Ratio

  baseline, 1, 2 and 3 years

• Percent body fat (estimated)

  baseline, 1, 2, and 3 years

Study Arms (2)

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

EXPERIMENTAL

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

Health and Nutrition Education

ACTIVE COMPARATOR

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

Interventions

MMM 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.

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

Health and Nutrition Education 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"

Health and Nutrition Education

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (5)

• 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.

  PMID: 24028942 BACKGROUND

• 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.

  PMID: 33933181 DERIVED

• 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.

  PMID: 32909523 DERIVED

• 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.

  PMID: 32153951 DERIVED

• 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.

  PMID: 31138278 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Health; Nutrition Assessment

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Thomas N Robinson, MD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and of Medicine

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: July 17, 2012
• Study Start: July 13, 2012
• Primary Completion: December 19, 2016
• Study Completion: December 19, 2016
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data currently available
• 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

Locations

US (1)