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Completed

NCT Number: NCT04516252

Enhancing BodyWorks: A Canine Health Literacy Module

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.

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Key information

Conditions

Overweight and Obesity Behavior Body Weight Human-Animal Interaction Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight Adolescents Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AltaMed@CHLA

Los Angeles, California, 90057, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Normal BMI
  • Do not own dog

Treatment and study plan

BodyWorks Intervention

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Change in Mean Physical Activity Associated With the BodyWorks + Canine Health Literacy Intervention for Parents and Adolescents

    Time frame: Baseline to 7 weeks

    Determine the mean of the average of the first 7 days (with valid data >100 steps) and the last 7 days of the intervention for intervention and control groups as measured by the physical activity trackers.

  2. Change From Baseline for Adolescent Affect Variability Associated With the BodyWorks + Canine Health Literacy Intervention.

    Time frame: Baseline to 7 weeks

    Determining the mean difference between the groups in the positive and negative affect ecological momentary assessment outcomes.

  3. Mean Number of Questions Answered for Adolescent Feasibility of Ecological Momentary Assessment

    Time frame: Baseline to week 7

    Feasibility will be determined by data completeness: Percentage of survey questions answered out of 13 possible questions.

  4. Number of Adolescents That Responded to Physical Acceptability of Ecological Momentary Assessment

    Time frame: Week 7 of intervention

    Acceptability will be measured by EMA prompt on physical activity with dog.

  5. Number of Parents and Adolescents Feasibility of Use of Physical Activity Trackers.

    Time frame: Baseline to 7 weeks

    Feasibility will be determined by data completeness: Number of adolescents and parents with meaningful data (greater than 100 steps >=7 days) out of participants with fitbit data.

  6. Mean Score of Parents and Adolescents Acceptability of Use of Physical Activity Trackers Using Likert Scale.

    Time frame: Week 7 of intervention

    Acceptability will be measured by response rate on user satisfaction survey. Likert Scale -2 (strongly disagree) to 2 (strongly agree). Higher values represent higher satisfaction.

  7. Mean Physical Activity for Parent and Adolescent Out of Participants With Fitbit Data.

    Time frame: Baseline to 7 weeks

    Number of steps per day

Secondary outcomes

  1. Change in Body Mass Index From Baseline for Adolescent

    Time frame: Baseline to 7 weeks

    Weight and height will be used to calculate BMI in kg/m^2

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Tufts Medical Center
  • University of Southern California

Registry information

Official study 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

Acronym: BW

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 18, 2020
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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