Enhancing BodyWorks: A Canine Health Literacy Module

Study Overview
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Brief Summary
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Dog ownership can serve as a vehicle for large-scale multi-level public health interventions, especially for pediatric overweight and obesity, due to dogs' unique place in children and adolescents' social networks.This study develops and tests a novel approach to design a Canine Health-Literacy module to enhance a Comprehensive Family Lifestyle Intervention BodyWorks, for dog-owning adolescents who have been diagnosed with overweight or obesity, and their parents. The results are anticipated to make an important step towards addressing the overweight and obesity epidemic among both people and companion dogs in the U.S.

Detailed Description
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This project is a feasibility, acceptability, and pilot study that leverages the psychosocial benefits of informed and attached dog ownership among treatment-naïve overweight or obese adolescents. It is based upon a socioecological model of health behavior that pursues multiple levels of influence, including those extending across species lines such as physical activity. BodyWorks, a Comprehensive Behavioral Family Lifestyle Interventions (CBFLI), a national, empirically validated, curriculum-based 8-week program (orientation and 7 weeks of curriculum) will be offered at Children's Hospital Los Angeles AltaMed Division of General Pediatrics, a Federally Qualified Healthcare Center. The aims of the study are: Specific Aim 1: Using current empirical evidence in veterinary medicine, to develop a Canine Health Literacy module (CHL) to be delivered as part of the existing, empirically tested BW curriculum to increase adolescents' health literacy about their dogs' physical activity needs, weight status, and nutrition. Specific Aim 2: Test the feasibility and acceptability of a concurrent approach using physical activity trackers and Ecological Momentary Assessment. 2(a): Test the feasibility and acceptability of objective measurement of physical activity using wireless fitness trackers for adolescents (FitBit Inspire), their parents (FitBit Inspire), and their dogs (FitBark); 2(b): Test the feasibility and acceptability of using mobile phones for Ecological Momentary Assessment of types and contexts of adolescent's physical activity with dogs. Specific Aim 3: To establish the size of the effect, and the variability associated with the 8 week-long BW + CHL module, as compared with the control group who received the standard BW program in 3(a) adolescents' positive affect during or after physical activity with the dog, as measured by the Ecological Momentary Assessment using prompts on mobile phones; and 3(b) levels of overall physical activity for the adolescents, their parents, and the dogs as measured by the FitBit Ace (adolescents), FitBit Flex2 (parents), and FitBark (dogs). The project will establish feasibility, acceptability, attrition, and protocol compliance, and will collect pilot data needed for power calculations in preparation for an R01 Randomized Controlled Trial as a next step to test the effectiveness of our enhanced BW+CHL program. This project represents a significant methodological and theoretical advancement in the field of Human-Animal Interaction (HAI) and in research on overweight and obesity.

Official Title
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A Health-literacy Module for Overweight Adolescents and Their Parents on Canine Physical Activity, Nutrition and Behavior: Enhancing Department of Health and Human Services' (DHHS) BodyWorks Program at a Federally Qualified Health Center

Conditions
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Overweight and Obesity, Overweight Adolescents

Intervention / Treatment
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* Behavioral: BodyWorks Intervention
* Behavioral: Canine Curriculum
* Behavioral: Ecological Momentary Assessment
* Behavioral: Physical Activity Trackers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight/obese youth ages 9-17 years and their caregivers Own dog Exclusion Criteria: Normal BMI Do not own dog

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Half of the BodyWorks families will be randomized to the intervention group, and will receive a PAT for the children, the parents, and the dogs at the beginning of the cycle; the children will respond to EMA surveys using a cell phone; the children and the parents will receive the Canine health literacy module in addition to the BW curriculum. | Behavioral: BodyWorks Intervention<br>* BodyWorks (BW), a Comprehensive Behavioral Family Lifestyle Interventions (CBFLI), a national, empirically validated, curriculum-based 7-week program will be implemented (Borden et al., 2012; DHHS, 2013)<br>Behavioral: Canine Curriculum<br>* Using our team's expertise in veterinary medicine, human-animal interaction, and animal behavior modification, develop an empirically-based, 7-week module on canine health and behavior.<br>Behavioral: Ecological Momentary Assessment<br>* Ecological Momentary Assessments (EMA) of physical activity will be conducted using mobile phones for 7 weeks of the BW program, prospectively collecting data on 4 days per week (Saturday to Tuesday) (Dunton et al., 2011; Liao et al., 2016).<br>Behavioral: Physical Activity Trackers<br>* Three types of consumer-grade wireless personal activity trackers (PATs): FitBit Inspire® designed for children 8 years of age and older; FitBit Inspire® for adults (Diaz et al., 2015; Espinoza et al., 2017); and FitBark®, wireless, global positioning systems (GPS)-based personal activity trackers for dogs (Patel et al., 2017). This approach will allow us to evaluate quantity (number of steps) and intensity of physical activity in the adolescents, their parents, and their dogs, as well as to synchronize Fitbit Ace and FitBark to establish the amount of shared physical activity of adolescents and their dogs.<br>|
| Active Comparator: Control<br>Half of the BodyWorks participants will be randomized to the control group and will receive a PAT at the beginning of the cycle for the children, the parents, and the dogs, and the children will respond to EMA surveys using cell phones. | Behavioral: BodyWorks Intervention<br>* BodyWorks (BW), a Comprehensive Behavioral Family Lifestyle Interventions (CBFLI), a national, empirically validated, curriculum-based 7-week program will be implemented (Borden et al., 2012; DHHS, 2013)<br>Behavioral: Ecological Momentary Assessment<br>* Ecological Momentary Assessments (EMA) of physical activity will be conducted using mobile phones for 7 weeks of the BW program, prospectively collecting data on 4 days per week (Saturday to Tuesday) (Dunton et al., 2011; Liao et al., 2016).<br>Behavioral: Physical Activity Trackers<br>* Three types of consumer-grade wireless personal activity trackers (PATs): FitBit Inspire® designed for children 8 years of age and older; FitBit Inspire® for adults (Diaz et al., 2015; Espinoza et al., 2017); and FitBark®, wireless, global positioning systems (GPS)-based personal activity trackers for dogs (Patel et al., 2017). This approach will allow us to evaluate quantity (number of steps) and intensity of physical activity in the adolescents, their parents, and their dogs, as well as to synchronize Fitbit Ace and FitBark to establish the amount of shared physical activity of adolescents and their dogs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variability associated with the BodyWorks + Canine Health Literacy intervention | Determining the mean difference between the groups' variability in the physical activity and ecological momentary assessment outcomes. | Change from baseline weight at 8 weeks | 
| Feasibility of Ecological Momentary Assessment | Feasibility will be determined by data completeness, i.e. the proportion of questions answered and the time it took to answer the items during a prompt. This will include the number of days and hours of data that can be obtained through the objective physical activity trackers. | Weeks 1, 4, 7 of intervention | 
| Acceptability of Ecological Momentary Assessment | Acceptability will be measured by qualitative, open-ended pen and paper surveys distributed to the adolescents in the study to calculate prevalence of responses. Descriptive data if these responses will be computed to get estimates of central tendency and variability within and between participants, and across time for planning of a future trial. | Week 8 of intervention | 
| Feasibility of use of physical activity trackers | Feasibility will be determined by data completeness and include the number of days and hours of data that can be obtained through the objective activity trackers. | Weeks 1-8 of intervention | 
| Acceptability of use of physical activity trackers | Acceptability will be measured by qualitative, open-ended pen and paper surveys distributed to participants. Descriptive data for acceptability will be prevalence of responses to be computed to get estimates of central tendency and variability for planning of a future trial. | Week 8 of intervention | 
| Physical activity for adolescents | Number of steps per day | daily for 8 weeks | 
| Physical activity for parents | Number of steps per day | daily for 8 weeks | 
| Physical activity for dogs | Number of steps per day | daily for 8 weeks | 
| Ecological Momentary assessments of adolescents | Each adolescent's affect ratings measured by ecological momentary assessments, administered by mobile phone prompts. | Week 1, 4, 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass index | Weight and height will be combined to report BMI in kg/m^2 | Change from baseline weight at 8 weeks | 
| Child weight | weight in kg or lbs | Change from baseline weight at 8 weeks | 
| Child height | height in meters or feet | Change from baseline weight at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight, Obesity, children, adolescents, comprehensive family lifestyle intervention program, telehealth, BodyWorks, Human Animal Interaction