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Enhancing BodyWorks: a Canine Health Literacy Module

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04516252
Acronym
BW
Enrollment
208
Registered
2020-08-18
Start date
2021-02-27
Completion date
2024-12-31
Last updated
2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity, Overweight Adolescents

Keywords

Overweight, Obesity, children, adolescents, comprehensive family lifestyle intervention program, telehealth, BodyWorks, Human Animal Interaction

Brief summary

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

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.

Interventions

BEHAVIORALBodyWorks Intervention

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)

BEHAVIORALCanine Curriculum

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.

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).

BEHAVIORALPhysical Activity Trackers

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.

Sponsors

University of Southern California
CollaboratorOTHER
Tufts Medical Center
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Children's Hospital Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Overweight/obese youth ages 9-17 years and their caregivers * Own dog

Exclusion criteria

* Normal BMI * Do not own dog

Design outcomes

Primary

MeasureTime frameDescription
Ecological Momentary assessments of adolescentsWeeks 1, 4, 7Mean adolescent affect ratings measured by ecological momentary assessments administered via text messages
Physical Activity Variability associated with the BodyWorks + Canine Health Literacy interventionChange from baseline physical activity at 7 weeksDetermining the mean difference between groups in the physical activity outcomes for number of steps per day as measured by the physical activity tracker
Affect Variability associated with the BodyWorks + Canine Health Literacy interventionChange from baseline affect at 7 weeksDetermining the mean difference between the groups in the positive and negative affect ecological momentary assessment outcomes.
Feasibility of Ecological Momentary AssessmentWeeks 1, 4, 7 of interventionFeasibility will be determined by data completeness: Ratio of questions answered during a wave to total number of possible questions.
Acceptability of Ecological Momentary AssessmentWeek 7 of interventionAcceptability will be measured by EMA prompt response rate out of the total possible responses.
Feasibility of use of physical activity trackersWeeks 1-7 of interventionFeasibility will be determined by data completeness: Ratio of days on which there are valid fitbit data out of the total number of days in terms of steps per day and minutes per day.
Acceptability of use of physical activity trackersWeek 7 of interventionAcceptability will be measured by response rate on user satisfaction survey.
Physical activity for adolescentsdaily for 7 weeksNumber of steps per day
Physical activity for parentsdaily for 7 weeksNumber of steps per day
Physical activity for dogsdaily for 7 weeksNumber of steps per day

Secondary

MeasureTime frameDescription
Body Mass indexChange from baseline BMI at 7 weeksWeight and height will be used to calculate BMI in kg/m\^2

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026