Clinical trial NCT04516252: Enhancing BodyWorks: a Canine Health Literacy Module
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Overweight Adolescents
Keywords: Overweight
Obesity
children
adolescents
comprehensive family lifestyle intervention program
telehealth
BodyWorks
Human Animal Interaction
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Tufts Medical Center
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-08-18
Enrollment: 208
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Normal BMI
* Do not own dog

Primary outcomes:
measure: Physical Activity Variability associated with the BodyWorks + Canine Health Literacy intervention
timeFrame: Change from baseline physical activity at 7 weeks
measure: Affect Variability associated with the BodyWorks + Canine Health Literacy intervention
timeFrame: Change from baseline affect at 7 weeks
measure: Feasibility of Ecological Momentary Assessment
timeFrame: Weeks 1, 4, 7 of intervention
measure: Acceptability of Ecological Momentary Assessment
timeFrame: Week 7 of intervention
measure: Feasibility of use of physical activity trackers
timeFrame: Weeks 1-7 of intervention
measure: Acceptability of use of physical activity trackers
timeFrame: Week 7 of intervention
measure: Physical activity for adolescents
timeFrame: daily for 7 weeks
measure: Physical activity for parents
timeFrame: daily for 7 weeks
measure: Physical activity for dogs
timeFrame: daily for 7 weeks
measure: Ecological Momentary assessments of adolescents
timeFrame: Weeks 1, 4, 7
Secondary outcomes:
measure: Body Mass index
timeFrame: Change from baseline BMI at 7 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AltaMed@CHLA
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Larry Yin, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: