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| ID | Type | Description | Link |
|---|---|---|---|
| U01HL103629 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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?
Single-blind study with all outcomes assessors (data collectors) and Investigators masked (blinded) to intervention assignment. Intention-to-treat analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multi-component, multi-level, multi-setting (MMM) | Experimental |
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| Health and Nutrition Education | Active Comparator | Enhanced standard care/health and nutrition education intervention:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMM | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| waist circumference | waist circumference in centimeters | baseline, 1, 2 and 3 years |
| triceps skinfold thickness | triceps skinfold thickness in mm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas N Robinson, MD, MPH | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24028942 | Background | 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. | |
| 33933181 | Derived |
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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
Data currently available
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
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D006262 | Health |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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|
| Health and Nutrition Education | Behavioral | Enhanced standard care/health and nutrition education intervention:
|
|
| baseline, 1, 2 and 3 years |
| Percent median BMI for age and sex (calculated from BMI) | age- and sex-adjusted BMI | baseline, 1, 2, and 3 years |
| Waist-to-Height Ratio | calculated from waist and height measures | baseline, 1, 2 and 3 years |
| Percent body fat (estimated) | 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) | lab assays of fasting samples | baseline, 1, 2 and 3 years |
| resting blood pressure | automated resting blood pressure | baseline, 1, 2 and 3 years |
| resting heart rate | automated pulse | baseline, 1, 2 and 3 years |
| physical activity measured by accelerometry | Actigraph model GT3X+ total and after school physical activity and sedentary behavior | baseline, 1, 2 and 3 years |
| screen time and other sedentary behaviors | 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 | Constant TV household measure | baseline, 1, 2, and 3 years |
| Average total daily energy intake | from 24 hour diet recalls | baseline, 1, 2 and 3 years |
| Percent of energy intake from fat | from 24 hour diet recalls | baseline, 1, 2, and 3 years |
| Added sugar | from 24 hour diet recalls | baseline, 1, 2, and 3 years |
| Eating with screens | breakfast, dinner and energy (from 24-hour diet recalls) | baseline, 1, 2, and 3 years |
| Depressive symptoms | Children's Depression Index short form | baseline, 1, 2 and 3 years |
| Weight Concerns | Overconcern with weight and shape scale | baseline, 1, 2 and 3 years |
| School performance | parent/guardian reported grades | baseline, 1, 2 and 3 years |
| Children's sleep habits | parent/guardian reported | baseline, 1, 2 and 3 years |
| Implicit theories | fixed versus growth mindset | baseline, 1, 2, and 3 years |
| Parent/guardian weight | measured weight | baseline, 1, 2, and 3 years |
| Parent/guardian body mass index | calculated from measures of height and weight | baseline, 1, 2, and 3 years |
| Parent/guardian waist circumference | waist circumference measured in cm | baseline, 1, 2, and 3 years |
| Parent/guardian reported physical activity | survey | baseline, 1, 2, and 3 years |
| Parent/guardian health literacy | New Vital Sign (NVS) measure | baseline, 1 and 2 years |
| 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. |
| 32909523 | 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. |
| 32153951 | 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. |
| 31138278 | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |