Overview

This trial is active, not recruiting.

Condition obesity
Treatments mmm, health and nutrition education
Phase phase 2
Sponsor Stanford University
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date July 2012
End date January 2017
Trial size 240 participants
Trial identifier NCT01642836, U01HL103629, spo47512

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?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
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)
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"
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"

Primary Outcomes

Measure
body mass index trajectory (change)
time frame: baseline, 1, 2 and 3 years

Secondary Outcomes

Measure
physical activity measured by accelerometry
time frame: baseline, 1, 2 and 3 years
waist circumference
time frame: baseline, 1, 2 and 3 years
triceps skinfold thickness
time frame: baseline, 1, 2 and 3 years
resting blood pressure
time frame: baseline, 1, 2 and 3 years
resting heart rate
time frame: baseline, 1, 2 and 3 years
fasting Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Insulin, glucose, hemoglobin A1c, high sensitivity C-Reactive Protein, ALT
time frame: baseline, 1, 2 and 3 years
screen time and other sedentary behaviors
time frame: baseline, 1, 2 and 3 years
Average total daily energy intake
time frame: baseline, 1, 2 and 3 years
Waist-to-Height Ratio
time frame: baseline, 1, 2 and 3 years
Weight Concerns
time frame: baseline, 1, 2 and 3 years
Depressive symptoms
time frame: baseline, 1, 2 and 3 years
School performance
time frame: baseline, 1, 2 and 3 years
Children's sleep habits
time frame: baseline, 1, 2 and 3 years

Eligibility Criteria

Male or female participants from 7 years up to 11 years old.

Inclusion Criteria: - 7-11 years of age - BMI greater than or equal to the 85th percentile for age and sex on the 2000 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.

Additional Information

Official title Clinic, Family & Community Collaboration to Treat Overweight and Obese Children
Principal investigator Thomas N Robinson, MD, MPH
Description Single-blind study with all outcomes assessors (data collectors) and Investigators masked (blinded) to intervention assignment. Intention-to-treat analysis.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Stanford University.