Trial Outcomes & Findings for Ideas Moving Parents and Adolescents to Change Together (IMPACT) (NCT NCT01514279)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

360 participants

Primary outcome timeframe

Baseline, 12 mos, 24 mos and 36 mos

Results posted on

2020-08-25

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	118	123	119
Overall Study COMPLETED	107	110	114
Overall Study NOT COMPLETED	11	13	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ideas Moving Parents and Adolescents to Change Together (IMPACT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HealthyCHANGE n=118 Participants 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.	SystemCHANGE n=123 Participants 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.	Tools4CHANGE n=119 Participants 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.	Total n=360 Participants Total of all reporting groups
Age, Continuous	11.58 years STANDARD_DEVIATION 0.56 • n=99 Participants	11.59 years STANDARD_DEVIATION 0.59 • n=107 Participants	11.51 years STANDARD_DEVIATION 0.56 • n=206 Participants	11.56 years STANDARD_DEVIATION 0.57 • n=7 Participants
Sex: Female, Male Female	66 Participants n=99 Participants	73 Participants n=107 Participants	69 Participants n=206 Participants	208 Participants n=7 Participants
Sex: Female, Male Male	52 Participants n=99 Participants	50 Participants n=107 Participants	50 Participants n=206 Participants	152 Participants n=7 Participants
Race/Ethnicity, Customized Child's Race/Ethnicity · Non-Hispanic White	4 Participants n=99 Participants	5 Participants n=107 Participants	5 Participants n=206 Participants	14 Participants n=7 Participants
Race/Ethnicity, Customized Child's Race/Ethnicity · Non-Hispanic Black	91 Participants n=99 Participants	92 Participants n=107 Participants	93 Participants n=206 Participants	276 Participants n=7 Participants
Race/Ethnicity, Customized Child's Race/Ethnicity · Hispanic	17 Participants n=99 Participants	24 Participants n=107 Participants	18 Participants n=206 Participants	59 Participants n=7 Participants
Race/Ethnicity, Customized Child's Race/Ethnicity · Multi-racial	5 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants	8 Participants n=7 Participants
Race/Ethnicity, Customized Child's Race/Ethnicity · Other	1 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	3 Participants n=7 Participants
Region of Enrollment United States	118 participants n=99 Participants	123 participants n=107 Participants	119 participants n=206 Participants	360 participants n=7 Participants
Body mass index	27.25 kg/m^2 STANDARD_DEVIATION 4.78 • n=99 Participants	27.36 kg/m^2 STANDARD_DEVIATION 5.12 • n=107 Participants	26.80 kg/m^2 STANDARD_DEVIATION 4.71 • n=206 Participants	27.14 kg/m^2 STANDARD_DEVIATION 4.87 • n=7 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HealthyCHANGE n=112 Participants 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.	SystemCHANGE n=117 Participants 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.	Tools4CHANGE n=117 Participants 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.
Slope of Body Mass Index (BMI)	0.821 kg/m^2/year Standard Deviation 1.363	1.083 kg/m^2/year Standard Deviation 1.129	0.952 kg/m^2/year Standard Deviation 1.318

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HealthyCHANGE n=106 Participants 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.	SystemCHANGE n=113 Participants 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.	Tools4CHANGE n=116 Participants 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.
Dietary Intake- Calories Per Day	12.49 kcal/d/year Standard Deviation 226.65	6.99 kcal/d/year Standard Deviation 211.04	24.03 kcal/d/year Standard Deviation 250.44

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HealthyCHANGE n=112 Participants 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.	SystemCHANGE n=116 Participants 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.	Tools4CHANGE n=117 Participants 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.
Blood Pressure Systolic Blood Pressure	1.245 mmHg/year Standard Deviation 3.319	1.130 mmHg/year Standard Deviation 3.075	0.886 mmHg/year Standard Deviation 2.787
Blood Pressure Diastolic Blood Pressure	-0.136 mmHg/year Standard Deviation 2.796	-0.074 mmHg/year Standard Deviation 2.726	-0.162 mmHg/year Standard Deviation 2.378
Blood Pressure Systolic Blood Pressure Percentile	-1.450 mmHg/year Standard Deviation 9.206	-2.044 mmHg/year Standard Deviation 8.063	-2.028 mmHg/year Standard Deviation 8.095
Blood Pressure Diastolic Blood Pressure Percentile	-2.335 mmHg/year Standard Deviation 8.228	-2.044 mmHg/year Standard Deviation 8.063	-2.132 mmHg/year Standard Deviation 6.645

SECONDARY outcome

Timeframe: [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.

Outcome measures

Outcome measures
Measure	HealthyCHANGE n=101 Participants 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.	SystemCHANGE n=105 Participants 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.	Tools4CHANGE n=109 Participants 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.
Physical Activity Number of moderate/vigorous minutes per day	-3.370 minutes/day/year Standard Deviation 10.123	-4.619 minutes/day/year Standard Deviation 7.486	-3.523 minutes/day/year Standard Deviation 8.493
Physical Activity Number of bed rest/sedentary minutes per day	10.501 minutes/day/year Standard Deviation 16.365	13.052 minutes/day/year Standard Deviation 14.561	11.022 minutes/day/year Standard Deviation 16.961

SECONDARY outcome

Timeframe: [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.

Outcome measures

Outcome measures
Measure	HealthyCHANGE n=111 Participants 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.	SystemCHANGE n=115 Participants 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.	Tools4CHANGE n=117 Participants 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.
Sleep Adolescent Sleep Wake	-1.061 score on a scale/year Standard Deviation 8.937	-1.552 score on a scale/year Standard Deviation 9.755	-1.184 score on a scale/year Standard Deviation 7.749
Sleep Pediatric Daytime Sleepiness	-0.239 score on a scale/year Standard Deviation 2.350	-0.361 score on a scale/year Standard Deviation 2.618	-0.273 score on a scale/year Standard Deviation 2.089

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HealthyCHANGE n=102 Participants 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.	SystemCHANGE n=106 Participants 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.	Tools4CHANGE n=108 Participants 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.
Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol LDL cholesterol	-1.449 mg/dL/year Standard Deviation 7.915	-1.970 mg/dL/year Standard Deviation 7.295	-2.357 mg/dL/year Standard Deviation 6.645
Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol Fasting glucose	-0.146 mg/dL/year Standard Deviation 2.864	-0.520 mg/dL/year Standard Deviation 3.805	-0490 mg/dL/year Standard Deviation 3.135
Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol HDL cholesterol	-0.300 mg/dL/year Standard Deviation 3.433	-0.600 mg/dL/year Standard Deviation 2.526	-0.385 mg/dL/year Standard Deviation 2.906
Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol Total cholesterol	-2.409 mg/dL/year Standard Deviation 9.500	-3.651 mg/dL/year Standard Deviation 8.280	-2.94 mg/dL/year Standard Deviation 7.201

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HealthyCHANGE n=109 Participants 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.	SystemCHANGE n=114 Participants 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.	Tools4CHANGE n=114 Participants 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.
Body Composition- BMI Percentile	-1.375 BMI percentile/year Standard Deviation 3.821	-0.258 BMI percentile/year Standard Deviation 1.552	-1.082 BMI percentile/year Standard Deviation 3.225

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HealthyCHANGE n=106 Participants 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.	SystemCHANGE n=109 Participants 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.	Tools4CHANGE n=109 Participants 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.
Fitness	1.084 laps completed/year Standard Deviation 2.640	0.533 laps completed/year Standard Deviation 3.663	1.715 laps completed/year Standard Deviation 3.491

SECONDARY outcome

Timeframe: [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.

Outcome measures

Outcome measures
Measure	HealthyCHANGE n=109 Participants 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.	SystemCHANGE n=115 Participants 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.	Tools4CHANGE n=117 Participants 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.
Quality of Life- Perceived Stress	0.313 scores on a scale/year Standard Deviation 2.620	-0.049 scores on a scale/year Standard Deviation 2.769	-0.026 scores on a scale/year Standard Deviation 2.491

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HealthyCHANGE n=106 Participants 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.	SystemCHANGE n=113 Participants 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.	Tools4CHANGE n=116 Participants 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.
Dietary Intake- Percent Calories From Fat	0.139 percent/year Standard Deviation 2.905	-0.050 percent/year Standard Deviation 2.589	-0.055 percent/year Standard Deviation 0.360

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	HealthyCHANGE n=106 Participants 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.	SystemCHANGE n=113 Participants 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.	Tools4CHANGE n=116 Participants 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.
Dietary Intake- Fruit and Vegetable Servings Number of vegetable servings per day	0.013 number of servings/day/year Standard Deviation 0.276	0.008 number of servings/day/year Standard Deviation 0.263	-0.008 number of servings/day/year Standard Deviation 0.253
Dietary Intake- Fruit and Vegetable Servings Number of fruit servings per day	-0.061 number of servings/day/year Standard Deviation 0.239	-0.050 number of servings/day/year Standard Deviation 0.234	-0.055 number of servings/day/year Standard Deviation 0.360

SECONDARY outcome

Timeframe: 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.