Increased Monitoring of Physical Activity and Calories With Technology

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Increased Monitoring of Physical Activity and Calories With Technology

Conditions
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Weight Change, Body, Behavior, Health, Obesity, Childhood, Parent-Child Relations

Intervention / Treatment
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* Behavioral: Brenner mFIT (standard care)
* Behavioral: Brenner mFIT (standard care plus mobile health components)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brenner FIT (Standard Care)<br>Adolescents will participate in Brenner Families in Training along with their caregiver. They will receive all components of standard Brenner FIT treatments. | Behavioral: Brenner mFIT (standard care)<br>* 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.<br>|
| Experimental: Brenner mFIT (standard care plus mobile health components)<br>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 | Behavioral: Brenner mFIT (standard care plus mobile health components)<br>* 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- a mobile-enabled website, diet and physical activity tracking apps and physical activity tracker tailored self-monitoring feedback caregiver podcasts animated videos for adolescent patients social support via social media.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI z-score | Weight status of caregivers and youth will be quantified through calculation of BMI derived from 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 Tanita(registered trademark) digital scale and a Seca(registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts. | Baseline | 
| BMI z-score | Weight status of caregivers and youth will be quantified through calculation of BMI derived from 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 Tanita(registered trademark) digital scale and a Seca(registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts. | 3 months | 
| BMI z-score | Weight status of caregivers and youth will be quantified through calculation of BMI derived from 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 Tanita(registered trademark) digital scale and a Seca(registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 mHealth intervention costs | Clinical costs of the mHealth intervention will be compiled over the duration of the program. | Baseline | 
| Economic costs of the mHealth intervention costs | Clinical costs of the mHealth intervention will be compiled over the duration of the program. | 3 months | 
| Economic costs of the mHealth intervention costs | Clinical costs of the mHealth intervention will be compiled over the duration of the program. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight management, pediatric weight management, mHealth, mobile technology, parent/child relations, dyad