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| ID | Type | Description | Link |
|---|---|---|---|
| 5U01HL103622-02 | 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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The National Heart, Lung, and Blood Institute (NHLBI) of the National Institute of Health (NIH) has sponsored a consortium of four sites across the United States, entitled Childhood Obesity Prevention and Treatment Research (COPTR). Each site has its own protocol. Case Western Reserve/Cleveland's project is entitled "Targeting Obesity and Blood Pressure in Urban Youth". The site name is IMPACT (Ideas Moving Parents and Adolescents to Change Together).
The project assesses the effects of three interventions on Body Mass Index(BMI) in overweight and obese urban 5th-8th grade youth: a cognitive-behavioral intervention (HealthyChange), a systems improvement intervention (SystemsChange), and an education-only intervention (Tools4Change). In addition the study assesses the potential additional impact of a school-community based intervention on outcomes.
The project has two phases: a formative phase (including focus groups and a pilot) and the main trial. The main trial will take place over approximately four years.
The IMPACT trial will involve a 3-arm randomized controlled trial of three behavioral and educational interventions: (1) HealthyCHANGE, a behavioral approach focusing on building skills and increasing intrinsic motivation (based on cognitive-behavioral theory with motivational interviewing components); (2) SystemCHANGE, an innovative behavioral approach focusing on system re-design of the family environment and daily routines (based on social-ecological and personal process improvement theories); and (3) education-only (representing usual care, called Tools4CHANGE).
In the main trial, approximately half of the children will also be in schools that take part in the We Run This City (WRTC)Marathon program, a school-based fitness program administered by the YMCA, and half will be in schools that do not take part in the WRTC program.
This study will assess the impact of the interventions on the main trial's (1) primary outcome, Change in Body Mass Index (BMI). (2) secondary outcomes including diet, physical activity, sedentary behavior, sleep, blood pressure, cardiovascular risk, body composition, fitness, and quality of life (3) mediators including : child's self-efficacy, social support, motivation, family problem solving ability, systems thinking, and self-regulation;(4) moderators including: socioeconomic status, demographic factors, environmental factors, personal and psychosocial characteristics of child and parent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HealthyCHANGE | Experimental | Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. |
|
| SystemCHANGE | Experimental | Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines |
|
| Tools4CHANGE | No Intervention | In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HealthyCHANGE | Behavioral | Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. |
| Measure | Description | Time Frame |
|---|---|---|
| Slope of Body Mass Index (BMI) | BMI slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without BMI values post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Baseline, 12 mos, 24 mos and 36 mos |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Intake- Calories Per Day | Annualized change in calories per day. Dietary intake slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Baseline, 12 mos, 24 mos and 36 mos |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elaine A Borawski, PhD | Case Western Reserve University | Principal Investigator |
| Shirley M Moore, RN, PhD | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Western Reserve University | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24008055 | Background | Moore SM, Borawski EA, Cuttler L, Ievers-Landis CE, Love TE. IMPACT: a multi-level family and school intervention targeting obesity in urban youth. Contemp Clin Trials. 2013 Nov;36(2):574-86. doi: 10.1016/j.cct.2013.08.009. Epub 2013 Sep 2. | |
| 37843478 | Derived | Schuler BR, Gardenhire RA, Jones SD, Spilsbury JC, Moore SM, Borawski EA. Exploring the Association Between Trauma, Instability, and Youth Cardiometabolic Health Outcomes Over Three Years. J Adolesc Health. 2024 Feb;74(2):301-311. doi: 10.1016/j.jadohealth.2023.08.049. Epub 2023 Oct 15. |
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Conducted in conjunction with the Research Coordinating Unit (UNC Chapel Hill) of the COPTR Consortium.
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Participants were recruited between May 2012 and January 2014 as part of an existing BMI and blood pressure screening program in the local school district. Participants were randomly assigned to 1 of 3 intervention study arms within 37 days of the baseline clinical visit once recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | HealthyCHANGE | Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. |
| FG001 | SystemCHANGE | Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. |
| FG002 | Tools4CHANGE | In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | HealthyCHANGE | Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Slope of Body Mass Index (BMI) | BMI slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without BMI values post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Posted | Mean | Standard Deviation | kg/m^2/year | Baseline, 12 mos, 24 mos and 36 mos |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HealthyCHANGE | Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac event | Cardiac disorders | Non-systematic Assessment | Any event related to the cardiovascular system |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elaine Borawski, PhD | School of Medicine, Case Western Reserve University | 216)368-1024 | exb11@case.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 30, 2012 | Jul 22, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009750 | Nutritional and Metabolic Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| SystemCHANGE | Behavioral | Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. |
|
| Blood Pressure | Annualized change in blood pressure measures using the slope of 3 year trajectory. Blood pressure slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood pressure readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Baseline, 12 mos, 24 mos and 36 mos |
| Physical Activity | Annualized change in physical activity measures of moderate to vigorous minutes per day and bed rest/sedentary minutes per day as measured by accelerometer. Physical activity slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without accelerometer readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | [Baseline, 12 mos, 24 mos and 36 mos] |
| Sleep | The results reflect the annualized change in adolescent sleep wake scale and pediatric daytime sleepiness scale. The items of the adolescent sleep wake scale are recoded to have a minimum of 0 and maximum value of 5, in which a higher scores for both the individual items and the overall sum score indicate a better outcome. The items of the pediatric daytime sleepiness are recoded to have a minimum of 0 and maximum value of 4, in which a lower score for both the individual items and the overall sum score indicates a better outcome. Sleep slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without post-baseline measures. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | [Baseline, 12 mos, 24 mos and 36 mos] |
| Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slopes of fasting glucose, HDL cholesterol, LDL cholesterol, and total cholesterol over 3 years reported. | Baseline, 12 mos, 24 mos and 36 mos |
| Body Composition- BMI Percentile | The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of BMI percentile over time reported. | Baseline, 12 mos, 24 mos and 36 mos |
| Fitness | The annualized change in pacer laps completed during PACER test over 3 years. PACER test slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without PACER test measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Baseline, 12 mos, 24 mos and 36 mos |
| Quality of Life- Perceived Stress | The annualized change in perceived stress over 3 years. Participants are asked to rate individual scale items on their perception of how often they feel specific stressors on a scale from 0 (never) to 4 (very often). Individual scale items are summed for a total score. Higher scores indicate higher perceived frequency of stressors, therefore higher perceived stress. Outcomes are reported as the mean of the slope estimates for total perceived stress score over 3 years (from baseline to 36 months). The perceived stress slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without stress scores post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | [Baseline, 12 mos, 24 mos and 36 mos] |
| Dietary Intake- Percent Calories From Fat | The annualized change of percent of calories from fat over 3 years. Percent calories from fat slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Baseline, 12 months, 24 months, 36 months |
| Dietary Intake- Fruit and Vegetable Servings | The annualized change in the number of fruit and vegetable servings per day over 3 years. Serving slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Baseline, 12 months, 24 months, 36 months |
| Dietary Intake- Sodium | The annualized change in sodium intake (mg) per day over 3 years. Sodium intake slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Baseline, 12 months, 24 months, 36 months |
| Cardiometabolic Factors- Hemoglobin A1c | Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of glycated Hemoglobin A1c over 3 years reported. | [Baseline, 12 mos, 24 mos, 36 mos] |
| Cardiometabolic Factors- High-sensitivity C-reactive Protein | Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of high-sensitivity C-reactive protein over 3 years reported. | [Baseline, 12 mos, 24 mos, 36 mos] |
| Cardiometabolic Factors- Insulin | Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of insulin over 3 years reported. | [Baseline, 12 mos, 24 mos, 36 mos] |
| Cardiometabolic Factors- HOMA-IR | Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of HOMA-IR over 3 years reported. | [Baseline, 12 mos, 24 mos, 36 mos] |
| Body Composition- Waist-to-height Ratio | The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of waist-to-height ratio over time reported. The weight-to-heigh ratio compares the child's waist circumference (cm) to their height (cm). | [Baseline, 12 mos, 24 mos, 36 mos] |
| Body Composition- Waist Circumference | The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of waist circumference (cm) over time reported. | [Baseline, 12 mos, 24 mos, 36 mos] |
| Body Composition- Percent Body Fat | The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of body fat percentage over time reported. Body fat percentage calculated using Stevens equation. | [Baseline, 12 mos, 24 mos, 36 mos] |
| 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. |
| 31126971 | Derived | Moore SM, Borawski EA, Love TE, Jones S, Casey T, McAleer S, Thomas C, Adegbite-Adeniyi C, Uli NK, Hardin HK, Trapl ES, Plow M, Stevens J, Truesdale KP, Pratt CA, Long M, Nevar A. Two Family Interventions to Reduce BMI in Low-Income Urban Youth: A Randomized Trial. Pediatrics. 2019 Jun;143(6):e20182185. doi: 10.1542/peds.2018-2185. |
| BG001 |
| SystemCHANGE |
Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. |
| BG002 | Tools4CHANGE | In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. |
| OG002 | Tools4CHANGE | In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. |
|
|
| Secondary | Dietary Intake- Calories Per Day | Annualized change in calories per day. Dietary intake slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Posted | Mean | Standard Deviation | kcal/d/year | Baseline, 12 mos, 24 mos and 36 mos |
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| Secondary | Blood Pressure | Annualized change in blood pressure measures using the slope of 3 year trajectory. Blood pressure slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood pressure readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Posted | Mean | Standard Deviation | mmHg/year | Baseline, 12 mos, 24 mos and 36 mos |
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| Secondary | Physical Activity | Annualized change in physical activity measures of moderate to vigorous minutes per day and bed rest/sedentary minutes per day as measured by accelerometer. Physical activity slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without accelerometer readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Posted | Mean | Standard Deviation | minutes/day/year | [Baseline, 12 mos, 24 mos and 36 mos] |
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| Secondary | Sleep | The results reflect the annualized change in adolescent sleep wake scale and pediatric daytime sleepiness scale. The items of the adolescent sleep wake scale are recoded to have a minimum of 0 and maximum value of 5, in which a higher scores for both the individual items and the overall sum score indicate a better outcome. The items of the pediatric daytime sleepiness are recoded to have a minimum of 0 and maximum value of 4, in which a lower score for both the individual items and the overall sum score indicates a better outcome. Sleep slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without post-baseline measures. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Posted | Mean | Standard Deviation | score on a scale/year | [Baseline, 12 mos, 24 mos and 36 mos] |
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| Secondary | Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slopes of fasting glucose, HDL cholesterol, LDL cholesterol, and total cholesterol over 3 years reported. | Posted | Mean | Standard Deviation | mg/dL/year | Baseline, 12 mos, 24 mos and 36 mos |
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| Secondary | Body Composition- BMI Percentile | The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of BMI percentile over time reported. | Posted | Mean | Standard Deviation | BMI percentile/year | Baseline, 12 mos, 24 mos and 36 mos |
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| Secondary | Fitness | The annualized change in pacer laps completed during PACER test over 3 years. PACER test slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without PACER test measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Posted | Mean | Standard Deviation | laps completed/year | Baseline, 12 mos, 24 mos and 36 mos |
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| Secondary | Quality of Life- Perceived Stress | The annualized change in perceived stress over 3 years. Participants are asked to rate individual scale items on their perception of how often they feel specific stressors on a scale from 0 (never) to 4 (very often). Individual scale items are summed for a total score. Higher scores indicate higher perceived frequency of stressors, therefore higher perceived stress. Outcomes are reported as the mean of the slope estimates for total perceived stress score over 3 years (from baseline to 36 months). The perceived stress slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without stress scores post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Posted | Mean | Standard Deviation | scores on a scale/year | [Baseline, 12 mos, 24 mos and 36 mos] |
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| Secondary | Dietary Intake- Percent Calories From Fat | The annualized change of percent of calories from fat over 3 years. Percent calories from fat slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Posted | Mean | Standard Deviation | percent/year | Baseline, 12 months, 24 months, 36 months |
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| Secondary | Dietary Intake- Fruit and Vegetable Servings | The annualized change in the number of fruit and vegetable servings per day over 3 years. Serving slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Posted | Mean | Standard Deviation | number of servings/day/year | Baseline, 12 months, 24 months, 36 months |
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| Secondary | Dietary Intake- Sodium | The annualized change in sodium intake (mg) per day over 3 years. Sodium intake slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. | Posted | Mean | Standard Deviation | mg/day/year | Baseline, 12 months, 24 months, 36 months |
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| Secondary | Cardiometabolic Factors- Hemoglobin A1c | Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of glycated Hemoglobin A1c over 3 years reported. | Posted | Mean | Standard Deviation | % glycated/year | [Baseline, 12 mos, 24 mos, 36 mos] |
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| Secondary | Cardiometabolic Factors- High-sensitivity C-reactive Protein | Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of high-sensitivity C-reactive protein over 3 years reported. | Posted | Mean | Standard Deviation | mg/L/year | [Baseline, 12 mos, 24 mos, 36 mos] |
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| Secondary | Cardiometabolic Factors- Insulin | Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of insulin over 3 years reported. | Posted | Mean | Standard Deviation | uU/mL/year | [Baseline, 12 mos, 24 mos, 36 mos] |
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| Secondary | Cardiometabolic Factors- HOMA-IR | Annualized change in various cardiometabolic factor measures over 3 years. Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in the slope of HOMA-IR over 3 years reported. | Posted | Mean | Standard Deviation | score on a scale/year | [Baseline, 12 mos, 24 mos, 36 mos] |
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| Secondary | Body Composition- Waist-to-height Ratio | The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of waist-to-height ratio over time reported. The weight-to-heigh ratio compares the child's waist circumference (cm) to their height (cm). | Posted | Mean | Standard Deviation | ratio/year | [Baseline, 12 mos, 24 mos, 36 mos] |
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| Secondary | Body Composition- Waist Circumference | The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of waist circumference (cm) over time reported. | Posted | Mean | Standard Deviation | cm/year | [Baseline, 12 mos, 24 mos, 36 mos] |
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| Secondary | Body Composition- Percent Body Fat | The annualized change in body composition measures over 3 years. Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05. Change in slope of body fat percentage over time reported. Body fat percentage calculated using Stevens equation. | Posted | Mean | Standard Deviation | percent/year | [Baseline, 12 mos, 24 mos, 36 mos] |
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| 0 |
| 118 |
| 30 |
| 118 |
| 0 |
| 118 |
| EG001 | SystemCHANGE | Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep. It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls. | 0 | 123 | 29 | 123 | 0 | 123 |
| EG002 | Tools4CHANGE | In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior. | 0 | 119 | 28 | 119 | 0 | 119 |
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| Diabetic event | Endocrine disorders | Non-systematic Assessment | Any event related to diabetes |
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| Diabetes-related complications | Endocrine disorders | Non-systematic Assessment |
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| Surgery | Eye disorders | Non-systematic Assessment |
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| Cancer diagnosis | Gastrointestinal disorders | Non-systematic Assessment |
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| Hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
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| Hospitalization | General disorders | Non-systematic Assessment |
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| Immune system disorder diagnosis | Immune system disorders | Non-systematic Assessment |
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| Immune system disorder complications | Immune system disorders | Non-systematic Assessment |
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| Event resulting in injury or poisoning | Injury, poisoning and procedural complications | Non-systematic Assessment | Non-study related events only |
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| Nervous system event | Nervous system disorders | Non-systematic Assessment |
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| Childbirth | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Pregnancy complications | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Psychiatric event | Psychiatric disorders | Non-systematic Assessment |
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| Event related to reproductive system | Reproductive system and breast disorders | Non-systematic Assessment |
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| Respiratory event | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Housefire | Social circumstances | Non-systematic Assessment |
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| Surgery | Surgical and medical procedures | Non-systematic Assessment |
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Not provided
Not provided
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| Systolic Blood Pressure Percentile |
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| Diastolic Blood Pressure Percentile |
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| LDL cholesterol |
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| Total cholesterol |
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