Clinical trial NCT01642836: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-07-17
Enrollment: 241
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: body mass index trajectory (change)
timeFrame: baseline, 1, 2 and 3 years
Secondary outcomes:
measure: waist circumference
timeFrame: baseline, 1, 2 and 3 years
measure: triceps skinfold thickness
timeFrame: baseline, 1, 2 and 3 years
measure: Percent median BMI for age and sex (calculated from BMI)
timeFrame: baseline, 1, 2, and 3 years
measure: Waist-to-Height Ratio
timeFrame: baseline, 1, 2 and 3 years
measure: Percent body fat (estimated)
timeFrame: baseline, 1, 2, and 3 years
measure: fasting Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Insulin, glucose, hemoglobin A1c, high sensitivity C-Reactive Protein, Alanine Aminotransferase (ALT)
timeFrame: baseline, 1, 2 and 3 years
measure: resting blood pressure
timeFrame: baseline, 1, 2 and 3 years
measure: resting heart rate
timeFrame: baseline, 1, 2 and 3 years
measure: physical activity measured by accelerometry
timeFrame: baseline, 1, 2 and 3 years
measure: screen time and other sedentary behaviors
timeFrame: baseline, 1, 2 and 3 years
measure: Typical household Television (TV) use
timeFrame: baseline, 1, 2, and 3 years
measure: Average total daily energy intake
timeFrame: baseline, 1, 2 and 3 years
measure: Percent of energy intake from fat
timeFrame: baseline, 1, 2, and 3 years
measure: Added sugar
timeFrame: baseline, 1, 2, and 3 years
measure: Eating with screens
timeFrame: baseline, 1, 2, and 3 years
measure: Depressive symptoms
timeFrame: baseline, 1, 2 and 3 years
measure: Weight Concerns
timeFrame: baseline, 1, 2 and 3 years
measure: School performance
timeFrame: baseline, 1, 2 and 3 years
measure: Children's sleep habits
timeFrame: baseline, 1, 2 and 3 years
measure: Implicit theories
timeFrame: baseline, 1, 2, and 3 years
measure: Parent/guardian weight
timeFrame: baseline, 1, 2, and 3 years
measure: Parent/guardian body mass index
timeFrame: baseline, 1, 2, and 3 years
measure: Parent/guardian waist circumference
timeFrame: baseline, 1, 2, and 3 years
measure: Parent/guardian reported physical activity
timeFrame: baseline, 1, 2, and 3 years
measure: Parent/guardian health literacy
timeFrame: baseline, 1 and 2 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Thomas N Robinson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.