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| ID | Type | Description | Link |
|---|---|---|---|
| R34DK119815 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Since severe obesity in youth has been steadily increasing. Specialized pediatric obesity clinics provide programs to aid in reducing obesity. Since the home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during behavioral weight loss interventions, a family-based treatment approach is best. This strategy has been moderately successful in our existing, evidence-based pediatric weight management program, Brenner Families In Training (Brenner FIT). However, since programs such as Brenner Families in Training rely on face-to-face interactions and delivery, they are sometimes by the time constraints experienced by families. Therefore, the purpose of this study is to develop and pilot a tailored, mobile health component to potentially increase the benefits seen by Brenner FIT standard program components and similar pediatric weight management programs.
For this project, we will randomize 80 youth with obesity (13 - 18yrs) and a caregiver (dyads) to the Brenner Families in Training (FIT) group or the Brenner Families in Training Mobile (mFIT) group. All youth participants will receive a commercially available activity monitor. Caregivers will receive podcasts with a story about a caregiver supporting weight loss in a child by providing healthy foods/activities for his/her family, including healthy eating and physical activity information. Children will receive animated videos that contain healthy eating and physical activity messaging, with an engaging story of a child losing weight. All participants will have access to a website and mobile apps where they will track weight, diet, and physical activity for themselves (youth) or their child (parents). Based on their reports of weight, eating, and physical activity, the messaging received from clinical staff by the families will be individually tailored to promote healthy behaviors and overcome perceived barriers. The proposed research is innovative in that it explicitly incorporates theory into the intervention and evaluation components of the project and builds upon an existing literature on mobile health interventions that use mobile technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brenner FIT (Standard Care) | Active Comparator | 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 plus mobile health components) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brenner mFIT (standard care) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| BMI Percentile | 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. | Baseline |
| BMI Percentile | 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. | 3 months |
| BMI Percentile | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Activity Via Accelerometry (Bouts of Physical Activity) | Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. | Baseline |
| Physical Activity Via Accelerometry (Bouts of Physical Activity) |
Not provided
Inclusion Criteria:
Youth with obesity, 13 - 18yrs, who are enrolled or eligible to enroll in Brenner Families in Training (FIT). Caregivers must live in the home with their youth participants. Obesity is defined a BMI (35.9 +/- 8.6). Participants must also have access to a smartphone or tablet
Exclusion Criteria:
Adolescents under the age of 13 will be excluded. If participants do not have access to a smartphone or tablet, they will not be able to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Justin B Moore, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brenner Children's Hospital | Winston-Salem | North Carolina | 27127 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26318950 | Background | Brown CL, Halvorson EE, Cohen GM, Lazorick S, Skelton JA. Addressing Childhood Obesity: Opportunities for Prevention. Pediatr Clin North Am. 2015 Oct;62(5):1241-61. doi: 10.1016/j.pcl.2015.05.013. Epub 2015 Jul 16. | |
| 20880126 | Background | Skelton JA, Beech BM. Attrition in paediatric weight management: a review of the literature and new directions. Obes Rev. 2011 May;12(5):e273-81. doi: 10.1111/j.1467-789X.2010.00803.x. Epub 2010 Sep 29. |
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Fourteen parent-child dyads provided consent and agreed to participate. In total, 28 participants (14 parents/14 children) were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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-
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The number of participants (N=14 per arm) reflects parents (7) and children (7) in each arm. For BMI/MVPA/caloric intake, the data were collected from children only, representing n=7 (standard care), n=7 (standard care plus) for BMI, n=4 (standard care), n=3 (standard care plus) for MVPA, n=7 (standard care), n=7 (standard care plus) for caloric intake. Data were not collected from the parents enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data are presented separately for parents and children. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | BMI Percentile | 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. | Posted | Mean | Standard Deviation | BMI percentile for age and sex | Baseline |
|
6 months
Adverse events were not monitored in the parents.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Due to the COVID-19 pandemic, participants did not provide three-month anthropometric, physical activity, or dietary data, and participation in six-month follow-up data collection was extremely low.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Justin B. Moore, PhD | Wake Forest Health Sciences | 336-716-3702 | jusmoore@wakehealth.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2021 | May 30, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2022 | Jun 1, 2023 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D015438 | Health Behavior |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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The control group will receive standard Brenner FIT care. The intervention group will receive standard Brenner FIT care in additional to mobile health components in the hopes of maximizing the benefits that are already seen with pediatric weight management programs like Brenner FIT.
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Not provided
|
| Brenner mFIT (standard care plus mobile health components) | Behavioral | 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-
|
|
| 6 months |
Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. |
| 3 months |
| Physical Activity Via Accelerometry (Bouts of Physical Activity) | Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. | 6 months |
| ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool | 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. | Baseline |
| ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool | 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. | 3 months |
| ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool | 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. | 6 months |
| Economic Costs of the Two Intervention Arms | 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. | Through study completion (6 months) |
| 21966612 | Background | Skelton JA, Goff DC Jr, Ip E, Beech BM. Attrition in a Multidisciplinary Pediatric Weight Management Clinic. Child Obes. 2011 Jun 20;7(3):185-193. doi: 10.1089/chi.2011.0010. |
| 24723990 | Background | Irby MB, Kolbash S, Garner-Edwards D, Skelton JA. Pediatric Obesity Treatment in Children With Neurodevelopmental Disabilities: A Case Series and Review of the Literature. Infant Child Adolesc Nutr. 2012 Aug 1;4(4):215-221. doi: 10.1177/1941406412448527. |
| 20939628 | Background | Irby M, Kaplan S, Garner-Edwards D, Kolbash S, Skelton JA. Motivational interviewing in a family-based pediatric obesity program: a case study. Fam Syst Health. 2010 Sep;28(3):236-46. doi: 10.1037/a0020101. |
| 27008068 | Background | Skelton JA, Martin S, Irby MB. Satisfaction and attrition in paediatric weight management. Clin Obes. 2016 Apr;6(2):143-53. doi: 10.1111/cob.12138. Epub 2016 Jan 27. |
| 23455686 | Background | Bishop J, Irby MB, Isom S, Blackwell CS, Vitolins MZ, Skelton JA. Diabetes prevention, weight loss, and social support: program participants' perceived influence on the health behaviors of their social support system. Fam Community Health. 2013 Apr-Jun;36(2):158-71. doi: 10.1097/FCH.0b013e318282b2d3. |
| 26018093 | Background | Giannini C, Irby MB, Skelton JA. Caregiver Expectations of Family-based Pediatric Obesity Treatment. Am J Health Behav. 2015 Jul;39(4):451-60. doi: 10.5993/AJHB.39.4.1. |
| 24723991 | Background | Skelton JA, Irby MB, Guzman MA, Beech BM. Children's Perceptions of Obesity and Health: A Focus Group Study With Hispanic Boys. Infant Child Adolesc Nutr. 2012 Oct 1;4(5):289-296. doi: 10.1177/1941406412446946. |
| 24672556 | Background | Cheng JK, Wen X, Coletti KD, Cox JE, Taveras EM. 2-Year BMI Changes of Children Referred for Multidisciplinary Weight Management. Int J Pediatr. 2014;2014:152586. doi: 10.1155/2014/152586. Epub 2014 Jan 30. |
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| 23429637 | Background | Turner-McGrievy GM, Beets MW, Moore JB, Kaczynski AT, Barr-Anderson DJ, Tate DF. Comparison of traditional versus mobile app self-monitoring of physical activity and dietary intake among overweight adults participating in an mHealth weight loss program. J Am Med Inform Assoc. 2013 May 1;20(3):513-8. doi: 10.1136/amiajnl-2012-001510. Epub 2013 Feb 21. |
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| 25747468 | Background | Brazendale K, Beets MW, Bornstein DB, Moore JB, Pate RR, Weaver RG, Falck RS, Chandler JL, Andersen LB, Anderssen SA, Cardon G, Cooper A, Davey R, Froberg K, Hallal PC, Janz KF, Kordas K, Kriemler S, Puder JJ, Reilly JJ, Salmon J, Sardinha LB, Timperio A, van Sluijs EMF; International Children's Accelerometry Database (ICAD) Collaborators. Equating accelerometer estimates among youth: The Rosetta Stone 2. J Sci Med Sport. 2016 Mar;19(3):242-249. doi: 10.1016/j.jsams.2015.02.006. Epub 2015 Feb 23. |
| Background | Chandler JL, Beets MW, Drenowatz C, et al. The Rosetta Stone for equating hip and wrist- based accelerometer derived estimates of physical activity among elementary aged youth. Under review. |
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| BG001 | 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-
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Data are presented separately for parents and children. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Data are presented separately for parents and children. | Count of Participants | Participants |
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| Race (NIH/OMB) | Data are presented separately for parents and children. | Count of Participants | Participants |
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| Body Mass Index percentile | This number corresponds to the body mass index (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. | Data presented are from children only. | Mean | Standard Deviation | BMI percentile for age and sex |
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| Moderate-to-vigorous physical activity (min/day) | 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. | Mean | Standard Deviation | Minutes/day |
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| Calories consumed per day | Data presented are from children only. | Mean | Standard Deviation | kcal/day |
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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.
| OG001 | 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-
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| Primary | BMI Percentile | 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. | Zero Participants arrived for their 3 Month Visit due to COVID | Posted | 3 months |
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| Primary | BMI Percentile | 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. | Data are presented for the three participants who provided data at the six-month follow-up. | Posted | Mean | Standard Deviation | BMI percentile for age and sex | 6 months |
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| Secondary | Physical Activity Via Accelerometry (Bouts of Physical Activity) | Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. | 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. | Posted | Mean | Standard Deviation | minutes per day | Baseline |
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| Secondary | Physical Activity Via Accelerometry (Bouts of Physical Activity) | Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. | Zero Participants arrived for their 3 Month Visit due to COVID | Posted | 3 months |
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| Secondary | Physical Activity Via Accelerometry (Bouts of Physical Activity) | Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping. | 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. | Posted | Mean | Standard Deviation | Minutes per day | 6 months |
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| Secondary | ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool | 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. | Posted | Mean | Standard Deviation | Number of Calories (kcal/day) | Baseline |
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| Secondary | ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool | 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. | Zero Participants arrived for their 3 Month Visit due to COVID | Posted | 3 months |
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| Secondary | ASA24 Automated Self Administered 24 Hour Dietary Assessment Tool | 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. | 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. | Posted | Mean | Standard Deviation | Number of Calories (kcal/day) | 6 months |
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| Secondary | Economic Costs of the Two Intervention Arms | 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. | Clinical costs of the mHealth intervention will be compiled over the duration of the program. | Posted | Number | US Dollars | Through study completion (6 months) |
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| Secondary | Economic Costs of the Two Intervention Arms | 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. | Clinical costs of the mHealth intervention will be compiled over the duration of the program | Posted | Number | US Dollars | Through study completion (6 months) |
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| Secondary | Economic Costs of the Two Intervention Arms | 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. | Clinical costs of the mHealth intervention will be compiled over the duration of the program | Posted | Number | US Dollars | Through study completion (6 months) |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | 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-
| 0 | 7 | 0 | 7 | 0 | 7 |
Not provided
Not provided
| D009765 |
| Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| Male |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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