Enhancing BodyWorks: A Canine Health Literacy Module

Overweight and Obesity Clinical Trial

— BW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04516252
• Other study ID #: CHLA-CG-19-00001
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2021
• Est. completion date: February 29, 2024

Study information

• Verified date: April 2023
• Source: Children's Hospital Los Angeles
• Contact: Olga Solomon, PhD
• Phone: 323-361-4112
• Email: osolomon[@]chla.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

Inclusion Criteria:

• Overweight/obese youth ages 9-17 years and their caregivers

• Own dog

Exclusion Criteria:

• Normal BMI

• Do not own dog

Related Conditions & MeSH terms

• Overweight
• Overweight Adolescents
• Overweight and Obesity

Intervention

Behavioral:
• BodyWorks 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)
• Canine 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 Assessment
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).
• Physical 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.

Locations

Country	Name	City	State
United States	AltaMed@CHLA	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	Tufts Medical Center, University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Physical activity for adolescents	Number of steps per day	daily for 8 weeks
Primary	Physical activity for parents	Number of steps per day	daily for 8 weeks
Primary	Physical activity for dogs	Number of steps per day	daily for 8 weeks
Primary	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	Body Mass index	Weight and height will be combined to report BMI in kg/m^2	Change from baseline weight at 8 weeks
Secondary	Child weight	weight in kg or lbs	Change from baseline weight at 8 weeks
Secondary	Child height	height in meters or feet	Change from baseline weight at 8 weeks