Obese, Overweight
Conditions
Keywords
Overweight, Obese, Over Nutrition, Nutrition Disorders, Body weight, Signs and Symptoms
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHealthyCHANGE
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.
BEHAVIORALSystemCHANGE
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Students entering the 6th grade who are found at the standard school screenings to be overweight or obese * (BMI 85th- 94th percentile or \> 95th percentile for age/sex respectively)
Exclusion criteria
* Taking medications that alter appetite or weight (e.g. glucocorticoids, metformin, insulin, Risperidone (Risperdal), Olanzapine (Zyprexa), Clozapine(Clozaril), Quetiapine (Seroquel), Ziprasidone (Geodon), Carbamazepine (Tegretol), Valproic acid (Depakote/Depakene/Depacon), Aripiprazole (Abilify), Orlistat (Xenical), Sibutramine (Meridia), Phentermine, Diethylproprion (Tenuate), Topirimate (Topamax), glitazones (thiazolidinediones) * Inability to understand English * Stage 2 hypertension or stage 1 hypertension with end organ damage (left ventricular hypertrophy, microalbuminuria) * Severe behavioral problems that preclude group participation (as reported by parent/guardian) * Child involvement in another weight management program * Family expectation to move from the region within 1 year * The presence of a known medical condition that itself causes obesity (e.g., Prader-Willi syndrome) or interfere with HbA1C ( sickle cell disease)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slope of Body Mass Index (BMI) | Baseline, 12 mos, 24 mos and 36 mos | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | Baseline, 12 mos, 24 mos and 36 mos | 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. |
| Physical Activity | [Baseline, 12 mos, 24 mos and 36 mos] | 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. |
| Sleep | [Baseline, 12 mos, 24 mos and 36 mos] | 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. |
| Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | Baseline, 12 mos, 24 mos and 36 mos | 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. |
| Body Composition- BMI Percentile | Baseline, 12 mos, 24 mos and 36 mos | 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. |
| Fitness | Baseline, 12 mos, 24 mos and 36 mos | 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. |
| Quality of Life- Perceived Stress | [Baseline, 12 mos, 24 mos and 36 mos] | 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. |
| Dietary Intake- Percent Calories From Fat | Baseline, 12 months, 24 months, 36 months | 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. |
| Dietary Intake- Calories Per Day | Baseline, 12 mos, 24 mos and 36 mos | 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. |
| Dietary Intake- Sodium | Baseline, 12 months, 24 months, 36 months | 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. |
| Cardiometabolic Factors- Hemoglobin A1c | [Baseline, 12 mos, 24 mos, 36 mos] | 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. |
| Cardiometabolic Factors- High-sensitivity C-reactive Protein | [Baseline, 12 mos, 24 mos, 36 mos] | 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. |
| Cardiometabolic Factors- Insulin | [Baseline, 12 mos, 24 mos, 36 mos] | 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. |
| Cardiometabolic Factors- HOMA-IR | [Baseline, 12 mos, 24 mos, 36 mos] | 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. |
| Body Composition- Waist-to-height Ratio | [Baseline, 12 mos, 24 mos, 36 mos] | 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). |
| Body Composition- Waist Circumference | [Baseline, 12 mos, 24 mos, 36 mos] | 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. |
| Body Composition- Percent Body Fat | [Baseline, 12 mos, 24 mos, 36 mos] | 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. |
| Dietary Intake- Fruit and Vegetable Servings | Baseline, 12 months, 24 months, 36 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 118 |
| 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. | 123 |
| 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. | 119 |
| Total | 360 |
Baseline characteristics
| Characteristic | HealthyCHANGE | SystemCHANGE | Tools4CHANGE | Total |
|---|---|---|---|---|
| Age, Continuous | 11.58 years STANDARD_DEVIATION 0.56 | 11.59 years STANDARD_DEVIATION 0.59 | 11.51 years STANDARD_DEVIATION 0.56 | 11.56 years STANDARD_DEVIATION 0.57 |
| Body mass index | 27.25 kg/m^2 STANDARD_DEVIATION 4.78 | 27.36 kg/m^2 STANDARD_DEVIATION 5.12 | 26.80 kg/m^2 STANDARD_DEVIATION 4.71 | 27.14 kg/m^2 STANDARD_DEVIATION 4.87 |
| Race/Ethnicity, Customized Child's Race/Ethnicity Hispanic | 17 Participants | 24 Participants | 18 Participants | 59 Participants |
| Race/Ethnicity, Customized Child's Race/Ethnicity Multi-racial | 5 Participants | 1 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized Child's Race/Ethnicity Non-Hispanic Black | 91 Participants | 92 Participants | 93 Participants | 276 Participants |
| Race/Ethnicity, Customized Child's Race/Ethnicity Non-Hispanic White | 4 Participants | 5 Participants | 5 Participants | 14 Participants |
| Race/Ethnicity, Customized Child's Race/Ethnicity Other | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 118 participants | 123 participants | 119 participants | 360 participants |
| Sex: Female, Male Female | 66 Participants | 73 Participants | 69 Participants | 208 Participants |
| Sex: Female, Male Male | 52 Participants | 50 Participants | 50 Participants | 152 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 118 | 0 / 123 | 0 / 119 |
| other Total, other adverse events | 0 / 118 | 0 / 123 | 0 / 119 |
| serious Total, serious adverse events | 30 / 118 | 29 / 123 | 28 / 119 |
Outcome results
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.
Time frame: Baseline, 12 mos, 24 mos and 36 mos
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthyCHANGE | Slope of Body Mass Index (BMI) | 0.821 kg/m^2/year | Standard Deviation 1.363 |
| SystemCHANGE | Slope of Body Mass Index (BMI) | 1.083 kg/m^2/year | Standard Deviation 1.129 |
| Tools4CHANGE | Slope of Body Mass Index (BMI) | 0.952 kg/m^2/year | Standard Deviation 1.318 |
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.
Time frame: Baseline, 12 mos, 24 mos and 36 mos
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HealthyCHANGE | Blood Pressure | Diastolic Blood Pressure Percentile | -2.335 mmHg/year | Standard Deviation 8.228 |
| HealthyCHANGE | Blood Pressure | Systolic Blood Pressure Percentile | -1.450 mmHg/year | Standard Deviation 9.206 |
| HealthyCHANGE | Blood Pressure | Systolic Blood Pressure | 1.245 mmHg/year | Standard Deviation 3.319 |
| HealthyCHANGE | Blood Pressure | Diastolic Blood Pressure | -0.136 mmHg/year | Standard Deviation 2.796 |
| SystemCHANGE | Blood Pressure | Systolic Blood Pressure | 1.130 mmHg/year | Standard Deviation 3.075 |
| SystemCHANGE | Blood Pressure | Diastolic Blood Pressure | -0.074 mmHg/year | Standard Deviation 2.726 |
| SystemCHANGE | Blood Pressure | Systolic Blood Pressure Percentile | -2.044 mmHg/year | Standard Deviation 8.063 |
| SystemCHANGE | Blood Pressure | Diastolic Blood Pressure Percentile | -2.044 mmHg/year | Standard Deviation 8.063 |
| Tools4CHANGE | Blood Pressure | Systolic Blood Pressure Percentile | -2.028 mmHg/year | Standard Deviation 8.095 |
| Tools4CHANGE | Blood Pressure | Diastolic Blood Pressure Percentile | -2.132 mmHg/year | Standard Deviation 6.645 |
| Tools4CHANGE | Blood Pressure | Systolic Blood Pressure | 0.886 mmHg/year | Standard Deviation 2.787 |
| Tools4CHANGE | Blood Pressure | Diastolic Blood Pressure | -0.162 mmHg/year | Standard Deviation 2.378 |
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.
Time frame: Baseline, 12 mos, 24 mos and 36 mos
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthyCHANGE | Body Composition- BMI Percentile | -1.375 BMI percentile/year | Standard Deviation 3.821 |
| SystemCHANGE | Body Composition- BMI Percentile | -0.258 BMI percentile/year | Standard Deviation 1.552 |
| Tools4CHANGE | Body Composition- BMI Percentile | -1.082 BMI percentile/year | Standard Deviation 3.225 |
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.
Time frame: [Baseline, 12 mos, 24 mos, 36 mos]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthyCHANGE | Body Composition- Percent Body Fat | -0.246 percent/year | Standard Deviation 2.376 |
| SystemCHANGE | Body Composition- Percent Body Fat | 0.299 percent/year | Standard Deviation 1.889 |
| Tools4CHANGE | Body Composition- Percent Body Fat | -0.044 percent/year | Standard Deviation 2.17 |
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.
Time frame: [Baseline, 12 mos, 24 mos, 36 mos]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthyCHANGE | Body Composition- Waist Circumference | 1.814 cm/year | Standard Deviation 3.584 |
| SystemCHANGE | Body Composition- Waist Circumference | 2.339 cm/year | Standard Deviation 2.839 |
| Tools4CHANGE | Body Composition- Waist Circumference | 2.200 cm/year | Standard Deviation 3.288 |
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).
Time frame: [Baseline, 12 mos, 24 mos, 36 mos]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthyCHANGE | Body Composition- Waist-to-height Ratio | -0.003 ratio/year | Standard Deviation 0.023 |
| SystemCHANGE | Body Composition- Waist-to-height Ratio | 0.002 ratio/year | Standard Deviation 0.017 |
| Tools4CHANGE | Body Composition- Waist-to-height Ratio | -0.001 ratio/year | Standard Deviation 0.02 |
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.
Time frame: Baseline, 12 mos, 24 mos and 36 mos
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HealthyCHANGE | Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | Fasting glucose | -0.146 mg/dL/year | Standard Deviation 2.864 |
| HealthyCHANGE | Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | LDL cholesterol | -1.449 mg/dL/year | Standard Deviation 7.915 |
| HealthyCHANGE | Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | HDL cholesterol | -0.300 mg/dL/year | Standard Deviation 3.433 |
| HealthyCHANGE | Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | Total cholesterol | -2.409 mg/dL/year | Standard Deviation 9.5 |
| SystemCHANGE | Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | Fasting glucose | -0.520 mg/dL/year | Standard Deviation 3.805 |
| SystemCHANGE | Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | Total cholesterol | -3.651 mg/dL/year | Standard Deviation 8.28 |
| SystemCHANGE | Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | LDL cholesterol | -1.970 mg/dL/year | Standard Deviation 7.295 |
| SystemCHANGE | Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | HDL cholesterol | -0.600 mg/dL/year | Standard Deviation 2.526 |
| Tools4CHANGE | Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | Total cholesterol | -2.94 mg/dL/year | Standard Deviation 7.201 |
| Tools4CHANGE | Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | LDL cholesterol | -2.357 mg/dL/year | Standard Deviation 6.645 |
| Tools4CHANGE | Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | HDL cholesterol | -0.385 mg/dL/year | Standard Deviation 2.906 |
| Tools4CHANGE | Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol | Fasting glucose | -0490 mg/dL/year | Standard Deviation 3.135 |
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.
Time frame: [Baseline, 12 mos, 24 mos, 36 mos]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthyCHANGE | Cardiometabolic Factors- Hemoglobin A1c | -0.040 % glycated/year | Standard Deviation 0.21 |
| SystemCHANGE | Cardiometabolic Factors- Hemoglobin A1c | -0.021 % glycated/year | Standard Deviation 0.304 |
| Tools4CHANGE | Cardiometabolic Factors- Hemoglobin A1c | -0.017 % glycated/year | Standard Deviation 0.093 |
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.
Time frame: [Baseline, 12 mos, 24 mos, 36 mos]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthyCHANGE | Cardiometabolic Factors- High-sensitivity C-reactive Protein | -0.013 mg/L/year | Standard Deviation 0.163 |
| SystemCHANGE | Cardiometabolic Factors- High-sensitivity C-reactive Protein | -0.002 mg/L/year | Standard Deviation 0.141 |
| Tools4CHANGE | Cardiometabolic Factors- High-sensitivity C-reactive Protein | -0.0185 mg/L/year | Standard Deviation 0.123 |
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.
Time frame: [Baseline, 12 mos, 24 mos, 36 mos]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthyCHANGE | Cardiometabolic Factors- HOMA-IR | 0.032 score on a scale/year | Standard Deviation 1.003 |
| SystemCHANGE | Cardiometabolic Factors- HOMA-IR | 0.037 score on a scale/year | Standard Deviation 1.281 |
| Tools4CHANGE | Cardiometabolic Factors- HOMA-IR | 0.004 score on a scale/year | Standard Deviation 1.009 |
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.
Time frame: [Baseline, 12 mos, 24 mos, 36 mos]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthyCHANGE | Cardiometabolic Factors- Insulin | 0.772 uU/mL/year | Standard Deviation 4.761 |
| SystemCHANGE | Cardiometabolic Factors- Insulin | 0.406 uU/mL/year | Standard Deviation 6.875 |
| Tools4CHANGE | Cardiometabolic Factors- Insulin | 0.228 uU/mL/year | Standard Deviation 4.568 |
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.
Time frame: Baseline, 12 mos, 24 mos and 36 mos
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthyCHANGE | Dietary Intake- Calories Per Day | 12.49 kcal/d/year | Standard Deviation 226.65 |
| SystemCHANGE | Dietary Intake- Calories Per Day | 6.99 kcal/d/year | Standard Deviation 211.04 |
| Tools4CHANGE | Dietary Intake- Calories Per Day | 24.03 kcal/d/year | Standard Deviation 250.44 |
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.
Time frame: Baseline, 12 months, 24 months, 36 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HealthyCHANGE | Dietary Intake- Fruit and Vegetable Servings | Number of fruit servings per day | -0.061 number of servings/day/year | Standard Deviation 0.239 |
| HealthyCHANGE | Dietary Intake- Fruit and Vegetable Servings | Number of vegetable servings per day | 0.013 number of servings/day/year | Standard Deviation 0.276 |
| SystemCHANGE | Dietary Intake- Fruit and Vegetable Servings | Number of fruit servings per day | -0.050 number of servings/day/year | Standard Deviation 0.234 |
| SystemCHANGE | Dietary Intake- Fruit and Vegetable Servings | Number of vegetable servings per day | 0.008 number of servings/day/year | Standard Deviation 0.263 |
| Tools4CHANGE | Dietary Intake- Fruit and Vegetable Servings | Number of fruit servings per day | -0.055 number of servings/day/year | Standard Deviation 0.36 |
| Tools4CHANGE | Dietary Intake- Fruit and Vegetable Servings | Number of vegetable servings per day | -0.008 number of servings/day/year | Standard Deviation 0.253 |
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.
Time frame: Baseline, 12 months, 24 months, 36 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthyCHANGE | Dietary Intake- Percent Calories From Fat | 0.139 percent/year | Standard Deviation 2.905 |
| SystemCHANGE | Dietary Intake- Percent Calories From Fat | -0.050 percent/year | Standard Deviation 2.589 |
| Tools4CHANGE | Dietary Intake- Percent Calories From Fat | -0.055 percent/year | Standard Deviation 0.36 |
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.
Time frame: Baseline, 12 months, 24 months, 36 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthyCHANGE | Dietary Intake- Sodium | -0.42 mg/day/year | Standard Deviation 425.79 |
| SystemCHANGE | Dietary Intake- Sodium | 26.46 mg/day/year | Standard Deviation 409.34 |
| Tools4CHANGE | Dietary Intake- Sodium | 39.15 mg/day/year | Standard Deviation 446.28 |
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.
Time frame: Baseline, 12 mos, 24 mos and 36 mos
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthyCHANGE | Fitness | 1.084 laps completed/year | Standard Deviation 2.64 |
| SystemCHANGE | Fitness | 0.533 laps completed/year | Standard Deviation 3.663 |
| Tools4CHANGE | Fitness | 1.715 laps completed/year | Standard Deviation 3.491 |
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.
Time frame: [Baseline, 12 mos, 24 mos and 36 mos]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HealthyCHANGE | Physical Activity | Number of moderate/vigorous minutes per day | -3.370 minutes/day/year | Standard Deviation 10.123 |
| HealthyCHANGE | Physical Activity | Number of bed rest/sedentary minutes per day | 10.501 minutes/day/year | Standard Deviation 16.365 |
| SystemCHANGE | Physical Activity | Number of moderate/vigorous minutes per day | -4.619 minutes/day/year | Standard Deviation 7.486 |
| SystemCHANGE | Physical Activity | Number of bed rest/sedentary minutes per day | 13.052 minutes/day/year | Standard Deviation 14.561 |
| Tools4CHANGE | Physical Activity | Number of moderate/vigorous minutes per day | -3.523 minutes/day/year | Standard Deviation 8.493 |
| Tools4CHANGE | Physical Activity | Number of bed rest/sedentary minutes per day | 11.022 minutes/day/year | Standard Deviation 16.961 |
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.
Time frame: [Baseline, 12 mos, 24 mos and 36 mos]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HealthyCHANGE | Quality of Life- Perceived Stress | 0.313 scores on a scale/year | Standard Deviation 2.62 |
| SystemCHANGE | Quality of Life- Perceived Stress | -0.049 scores on a scale/year | Standard Deviation 2.769 |
| Tools4CHANGE | Quality of Life- Perceived Stress | -0.026 scores on a scale/year | Standard Deviation 2.491 |
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.
Time frame: [Baseline, 12 mos, 24 mos and 36 mos]
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HealthyCHANGE | Sleep | Adolescent Sleep Wake | -1.061 score on a scale/year | Standard Deviation 8.937 |
| HealthyCHANGE | Sleep | Pediatric Daytime Sleepiness | -0.239 score on a scale/year | Standard Deviation 2.35 |
| SystemCHANGE | Sleep | Adolescent Sleep Wake | -1.552 score on a scale/year | Standard Deviation 9.755 |
| SystemCHANGE | Sleep | Pediatric Daytime Sleepiness | -0.361 score on a scale/year | Standard Deviation 2.618 |
| Tools4CHANGE | Sleep | Adolescent Sleep Wake | -1.184 score on a scale/year | Standard Deviation 7.749 |
| Tools4CHANGE | Sleep | Pediatric Daytime Sleepiness | -0.273 score on a scale/year | Standard Deviation 2.089 |