Trial Outcomes & Findings for Increased Monitoring of Physical Activity and Calories With Technology (NCT NCT03961061)

Last Updated: 2024-11-08

Results Overview

The weight status of youth will be quantified through the calculation of BMI derived from the measurement of height and weight at the intake and follow-up visits. Both height (plus/minus 0.1 cm) and weight(plus/minus 0.5 kg) will be recorded twice, and values will be averaged to produce the final value using a digital scale and a stadiometer. BMI will be calculated as kg/m2. BMI z-score will be calculated using CDC growth charts and converted to BMI-for-age percentile based on CDC growth charts for children and teens ages 2 through 19. According to the CDC, a child with a BMI percentile less than the 5th percentile is underweight, between the 5th percentile and less than the 85th percentile is at a "healthy weight," over the 85th percentile to less than the 95th percentile has overweight, and above the 95th percentile has obesity.

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

Baseline

Results posted on

2024-11-08

Participant Flow

Fourteen parent-child dyads provided consent and agreed to participate. In total, 28 participants (14 parents/14 children) were randomized.

Participant milestones

Participant milestones
Measure	Brenner FIT (Standard Care) Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments. Brenner mFIT (standard care): Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.	Brenner mFIT (Standard Care Plus Mobile Health Components) Adolescents will participate in Brenner Families in Training along with their caregiver. Brenner mFIT (Families in Training + mobile health) includes all components of the standard Brenner FIT Brenner mFIT (standard care plus mobile health components): Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components. The six mHealth components that will be used in addition to standard Brenner Families in Training program include- 1. a mobile-enabled website, 2. diet and physical activity tracking apps and physical activity tracker 3. tailored self-monitoring feedback 4. caregiver podcasts 5. animated videos for adolescent patients 6. social support via social media.
Overall Study STARTED	14	14
Overall Study COMPLETED	4	2
Overall Study NOT COMPLETED	10	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data are presented separately for parents and children.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Brenner FIT (Standard Care) n=7 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments. Brenner mFIT (standard care): Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.	Brenner mFIT (Standard Care Plus Mobile Health Components) n=7 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. Brenner mFIT (Families in Training + mobile health) includes all components of the standard Brenner FIT Brenner mFIT (standard care plus mobile health components): Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components. The six mHealth components that will be used in addition to standard Brenner Families in Training program include- 1. a mobile-enabled website, 2. diet and physical activity tracking apps and physical activity tracker 3. tailored self-monitoring feedback 4. caregiver podcasts 5. animated videos for adolescent patients 6. social support via social media.
BMI Percentile	98.46 BMI percentile for age and sex Standard Deviation 2.39	99.37 BMI percentile for age and sex Standard Deviation .53

PRIMARY outcome

Timeframe: 3 months

Population: Zero Participants arrived for their 3 Month Visit due to COVID

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: Data are presented for the three participants who provided data at the six-month follow-up.

Outcome measures

Outcome measures
Measure	Brenner FIT (Standard Care) n=2 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments. Brenner mFIT (standard care): Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.	Brenner mFIT (Standard Care Plus Mobile Health Components) n=1 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. Brenner mFIT (Families in Training + mobile health) includes all components of the standard Brenner FIT Brenner mFIT (standard care plus mobile health components): Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components. The six mHealth components that will be used in addition to standard Brenner Families in Training program include- 1. a mobile-enabled website, 2. diet and physical activity tracking apps and physical activity tracker 3. tailored self-monitoring feedback 4. caregiver podcasts 5. animated videos for adolescent patients 6. social support via social media.
BMI Percentile	99 BMI percentile for age and sex Standard Deviation 1.27	99.9 BMI percentile for age and sex Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline

Population: Measure Analysis Population Description: Three participants in the standard care group and four participants in the standard care plus group did not provide valid data for analysis.

Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping.

Outcome measures

Outcome measures
Measure	Brenner FIT (Standard Care) n=4 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments. Brenner mFIT (standard care): Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.	Brenner mFIT (Standard Care Plus Mobile Health Components) n=3 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. Brenner mFIT (Families in Training + mobile health) includes all components of the standard Brenner FIT Brenner mFIT (standard care plus mobile health components): Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components. The six mHealth components that will be used in addition to standard Brenner Families in Training program include- 1. a mobile-enabled website, 2. diet and physical activity tracking apps and physical activity tracker 3. tailored self-monitoring feedback 4. caregiver podcasts 5. animated videos for adolescent patients 6. social support via social media.
Physical Activity Via Accelerometry (Bouts of Physical Activity)	60.75 minutes per day Standard Deviation 54.63	73.33 minutes per day Standard Deviation 49.14

SECONDARY outcome

Timeframe: 3 months

Population: Zero Participants arrived for their 3 Month Visit due to COVID

Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Two participants in the Standard Care group and one participant in the Standard Care Plus group were provided with accelerometers for the study at six-months follow-up. The participant in the Brenner mFIT did not provide the a minimum of valid days of data (3 or more), so data should be interpreted with caution.

Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping.

Outcome measures

Outcome measures
Measure	Brenner FIT (Standard Care) n=2 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments. Brenner mFIT (standard care): Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.	Brenner mFIT (Standard Care Plus Mobile Health Components) n=1 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. Brenner mFIT (Families in Training + mobile health) includes all components of the standard Brenner FIT Brenner mFIT (standard care plus mobile health components): Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components. The six mHealth components that will be used in addition to standard Brenner Families in Training program include- 1. a mobile-enabled website, 2. diet and physical activity tracking apps and physical activity tracker 3. tailored self-monitoring feedback 4. caregiver podcasts 5. animated videos for adolescent patients 6. social support via social media.
Physical Activity Via Accelerometry (Bouts of Physical Activity)	13.5 Minutes per day Standard Deviation 5.0	21.0 Minutes per day Standard Deviation 0.0

SECONDARY outcome

Timeframe: Baseline

To assess diet in participating youth, we will use NCI's automated, self-administered 24-hour dietary recall, the Automated Self-Administered 24-hour (ASA24 (registered trademark) dietary assessment tool (version: ASA24-2016) on three, non-consecutive days (including one weekend day). Caloric intake will be expressed in kilocalories in order to compare dietary behavior following the delivery of some program components. There are no specific ranges.

Outcome measures

Outcome measures
Measure	Brenner FIT (Standard Care) n=7 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments. Brenner mFIT (standard care): Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.	Brenner mFIT (Standard Care Plus Mobile Health Components) n=7 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. Brenner mFIT (Families in Training + mobile health) includes all components of the standard Brenner FIT Brenner mFIT (standard care plus mobile health components): Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components. The six mHealth components that will be used in addition to standard Brenner Families in Training program include- 1. a mobile-enabled website, 2. diet and physical activity tracking apps and physical activity tracker 3. tailored self-monitoring feedback 4. caregiver podcasts 5. animated videos for adolescent patients 6. social support via social media.
ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool	2135.27 Number of Calories (kcal/day) Standard Deviation 806.66	2078.03 Number of Calories (kcal/day) Standard Deviation 889.06

SECONDARY outcome

Timeframe: 3 months

Population: Zero Participants arrived for their 3 Month Visit due to COVID

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Three participants in the Standard Care group and no participants in the Standard Care Plus group provided data. Since one group had no participants, no analysis could be performed.

Outcome measures

Outcome measures
Measure	Brenner FIT (Standard Care) n=3 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments. Brenner mFIT (standard care): Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.	Brenner mFIT (Standard Care Plus Mobile Health Components) Adolescents will participate in Brenner Families in Training along with their caregiver. Brenner mFIT (Families in Training + mobile health) includes all components of the standard Brenner FIT Brenner mFIT (standard care plus mobile health components): Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components. The six mHealth components that will be used in addition to standard Brenner Families in Training program include- 1. a mobile-enabled website, 2. diet and physical activity tracking apps and physical activity tracker 3. tailored self-monitoring feedback 4. caregiver podcasts 5. animated videos for adolescent patients 6. social support via social media.
ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool	1650.6 Number of Calories (kcal/day) Standard Deviation 679.6	—

SECONDARY outcome

Timeframe: Through study completion (6 months)

Population: Clinical costs of the mHealth intervention will be compiled over the duration of the program.

Clinical costs of the mHealth intervention will be compiled over the duration of the program. The number of participants reflects the number who remained in the program. Since the data refer to the costs of the participants' care and were not collected directly from the participants, the number of participants analyzed is not consistent with the other outcome measures. The intervention cost was calculated at the group level and not per participant.

Outcome measures

Outcome measures
Measure	Brenner FIT (Standard Care) n=7 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments. Brenner mFIT (standard care): Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.	Brenner mFIT (Standard Care Plus Mobile Health Components) n=7 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. Brenner mFIT (Families in Training + mobile health) includes all components of the standard Brenner FIT Brenner mFIT (standard care plus mobile health components): Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components. The six mHealth components that will be used in addition to standard Brenner Families in Training program include- 1. a mobile-enabled website, 2. diet and physical activity tracking apps and physical activity tracker 3. tailored self-monitoring feedback 4. caregiver podcasts 5. animated videos for adolescent patients 6. social support via social media.
Economic Costs of the Two Intervention Arms	2,616 US Dollars	3,482 US Dollars

SECONDARY outcome

Timeframe: Through study completion (6 months)

Population: Clinical costs of the mHealth intervention will be compiled over the duration of the program

Outcome measures

Outcome measures
Measure	Brenner FIT (Standard Care) n=7 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments. Brenner mFIT (standard care): Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.	Brenner mFIT (Standard Care Plus Mobile Health Components) n=7 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. Brenner mFIT (Families in Training + mobile health) includes all components of the standard Brenner FIT Brenner mFIT (standard care plus mobile health components): Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components. The six mHealth components that will be used in addition to standard Brenner Families in Training program include- 1. a mobile-enabled website, 2. diet and physical activity tracking apps and physical activity tracker 3. tailored self-monitoring feedback 4. caregiver podcasts 5. animated videos for adolescent patients 6. social support via social media.
Economic Costs of the Two Intervention Arms	2616 US Dollars	3482 US Dollars

SECONDARY outcome

Timeframe: Through study completion (6 months)

Population: Clinical costs of the mHealth intervention will be compiled over the duration of the program

Outcome measures

Outcome measures
Measure	Brenner FIT (Standard Care) n=7 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments. Brenner mFIT (standard care): Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.	Brenner mFIT (Standard Care Plus Mobile Health Components) n=7 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. Brenner mFIT (Families in Training + mobile health) includes all components of the standard Brenner FIT Brenner mFIT (standard care plus mobile health components): Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components. The six mHealth components that will be used in addition to standard Brenner Families in Training program include- 1. a mobile-enabled website, 2. diet and physical activity tracking apps and physical activity tracker 3. tailored self-monitoring feedback 4. caregiver podcasts 5. animated videos for adolescent patients 6. social support via social media.
Economic Costs of the Two Intervention Arms	2616 US Dollars	3482 US Dollars

Adverse Events

Brenner FIT (Standard Care)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brenner mFIT (Standard Care Plus Mobile Health Components)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Justin B. Moore, PhD

Wake Forest Health Sciences

Phone: 336-716-3702

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Brenner FIT (Standard Care) n=14 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments. Brenner mFIT (standard care): Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.	Brenner mFIT (Standard Care Plus Mobile Health Components) n=14 Participants Adolescents will participate in Brenner Families in Training along with their caregiver. Brenner mFIT (Families in Training + mobile health) includes all components of the standard Brenner FIT Brenner mFIT (standard care plus mobile health components): Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components. The six mHealth components that will be used in addition to standard Brenner Families in Training program include- 1. a mobile-enabled website, 2. diet and physical activity tracking apps and physical activity tracker 3. tailored self-monitoring feedback 4. caregiver podcasts 5. animated videos for adolescent patients 6. social support via social media.	Total n=28 Participants Total of all reporting groups
Age, Continuous Children	16.1 years STANDARD_DEVIATION 1.2 • n=7 Participants • Data are presented separately for parents and children.	15.0 years STANDARD_DEVIATION 2.0 • n=7 Participants • Data are presented separately for parents and children.	15.6 years STANDARD_DEVIATION 1.7 • n=14 Participants • Data are presented separately for parents and children.
Age, Continuous Parents	44.7 years STANDARD_DEVIATION 5.2 • n=7 Participants • Data are presented separately for parents and children.	36.6 years STANDARD_DEVIATION 4.0 • n=7 Participants • Data are presented separately for parents and children.	40.6 years STANDARD_DEVIATION 6.1 • n=14 Participants • Data are presented separately for parents and children.
Sex: Female, Male Children · Female	2 Participants n=7 Participants • Data are presented separately for parents and children.	2 Participants n=7 Participants • Data are presented separately for parents and children.	4 Participants n=14 Participants • Data are presented separately for parents and children.
Sex: Female, Male Children · Male	5 Participants n=7 Participants • Data are presented separately for parents and children.	5 Participants n=7 Participants • Data are presented separately for parents and children.	10 Participants n=14 Participants • Data are presented separately for parents and children.
Sex: Female, Male Parents · Female	7 Participants n=7 Participants • Data are presented separately for parents and children.	7 Participants n=7 Participants • Data are presented separately for parents and children.	14 Participants n=14 Participants • Data are presented separately for parents and children.
Sex: Female, Male Parents · Male	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=14 Participants • Data are presented separately for parents and children.
Ethnicity (NIH/OMB) Children · Hispanic or Latino	1 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=7 Participants • Data are presented separately for parents and children.	1 Participants n=14 Participants • Data are presented separately for parents and children.
Ethnicity (NIH/OMB) Children · Not Hispanic or Latino	6 Participants n=7 Participants • Data are presented separately for parents and children.	7 Participants n=7 Participants • Data are presented separately for parents and children.	13 Participants n=14 Participants • Data are presented separately for parents and children.
Ethnicity (NIH/OMB) Children · Unknown or Not Reported	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=14 Participants • Data are presented separately for parents and children.
Ethnicity (NIH/OMB) Parents · Hispanic or Latino	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=14 Participants • Data are presented separately for parents and children.
Ethnicity (NIH/OMB) Parents · Not Hispanic or Latino	7 Participants n=7 Participants • Data are presented separately for parents and children.	7 Participants n=7 Participants • Data are presented separately for parents and children.	14 Participants n=14 Participants • Data are presented separately for parents and children.
Ethnicity (NIH/OMB) Parents · Unknown or Not Reported	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=14 Participants • Data are presented separately for parents and children.
Race (NIH/OMB) Children · American Indian or Alaska Native	0 Participants n=7 Participants • Data are presented separately for parents and children.	1 Participants n=7 Participants • Data are presented separately for parents and children.	1 Participants n=14 Participants • Data are presented separately for parents and children.
Race (NIH/OMB) Children · Asian	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=14 Participants • Data are presented separately for parents and children.
Race (NIH/OMB) Children · Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=14 Participants • Data are presented separately for parents and children.
Race (NIH/OMB) Children · Black or African American	3 Participants n=7 Participants • Data are presented separately for parents and children.	5 Participants n=7 Participants • Data are presented separately for parents and children.	8 Participants n=14 Participants • Data are presented separately for parents and children.
Race (NIH/OMB) Children · White	4 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=7 Participants • Data are presented separately for parents and children.	4 Participants n=14 Participants • Data are presented separately for parents and children.
Race (NIH/OMB) Children · More than one race	0 Participants n=7 Participants • Data are presented separately for parents and children.	1 Participants n=7 Participants • Data are presented separately for parents and children.	1 Participants n=14 Participants • Data are presented separately for parents and children.
Race (NIH/OMB) Children · Unknown or Not Reported	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=14 Participants • Data are presented separately for parents and children.
Race (NIH/OMB) Parents · American Indian or Alaska Native	0 Participants n=7 Participants • Data are presented separately for parents and children.	1 Participants n=7 Participants • Data are presented separately for parents and children.	1 Participants n=14 Participants • Data are presented separately for parents and children.
Race (NIH/OMB) Parents · Asian	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=14 Participants • Data are presented separately for parents and children.
Race (NIH/OMB) Parents · Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=14 Participants • Data are presented separately for parents and children.
Race (NIH/OMB) Parents · Black or African American	3 Participants n=7 Participants • Data are presented separately for parents and children.	5 Participants n=7 Participants • Data are presented separately for parents and children.	8 Participants n=14 Participants • Data are presented separately for parents and children.
Race (NIH/OMB) Parents · White	4 Participants n=7 Participants • Data are presented separately for parents and children.	1 Participants n=7 Participants • Data are presented separately for parents and children.	5 Participants n=14 Participants • Data are presented separately for parents and children.
Race (NIH/OMB) Parents · More than one race	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=14 Participants • Data are presented separately for parents and children.
Race (NIH/OMB) Parents · Unknown or Not Reported	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=7 Participants • Data are presented separately for parents and children.	0 Participants n=14 Participants • Data are presented separately for parents and children.
Body Mass Index percentile	98.46 BMI percentile for age and sex STANDARD_DEVIATION 2.39 • n=7 Participants • Data presented are from children only.	99.37 BMI percentile for age and sex STANDARD_DEVIATION .53 • n=7 Participants • Data presented are from children only.	98.91 BMI percentile for age and sex STANDARD_DEVIATION 1.73 • n=14 Participants • Data presented are from children only.
Moderate-to-vigorous physical activity (min/day)	60.75 Minutes/day STANDARD_DEVIATION 54.63 • n=4 Participants • Data presented are from children only. Four participants in the standard care group and 3 participants in the standard care plus group did not provide valid data for analysis.	73.33 Minutes/day STANDARD_DEVIATION 49.14 • n=3 Participants • Data presented are from children only. Four participants in the standard care group and 3 participants in the standard care plus group did not provide valid data for analysis.	66.14 Minutes/day STANDARD_DEVIATION 48.40 • n=7 Participants • Data presented are from children only. Four participants in the standard care group and 3 participants in the standard care plus group did not provide valid data for analysis.
Calories consumed per day	2135.27 kcal/day STANDARD_DEVIATION 806.66 • n=7 Participants • Data presented are from children only.	2078.03 kcal/day STANDARD_DEVIATION 889.06 • n=7 Participants • Data presented are from children only.	2106.65 kcal/day STANDARD_DEVIATION 816.10 • n=14 Participants • Data presented are from children only.