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Enhancing BodyWorks: A Canine Health Literacy Module (BW)

Primary Purpose

Overweight and Obesity, Overweight Adolescents

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BodyWorks Intervention
Canine Curriculum
Ecological Momentary Assessment
Physical Activity Trackers
Sponsored by
Children's Hospital Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight and Obesity focused on measuring Overweight, Obesity, children, adolescents, comprehensive family lifestyle intervention program, telehealth, BodyWorks, Human Animal Interaction

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Normal BMI
  • Do not own dog

Sites / Locations

  • AltaMed@CHLARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
Physical activity for adolescents
Number of steps per day
Physical activity for parents
Number of steps per day
Physical activity for dogs
Number of steps per day
Ecological Momentary assessments of adolescents
Each adolescent's affect ratings measured by ecological momentary assessments, administered by mobile phone prompts.

Secondary Outcome Measures

Body Mass index
Weight and height will be combined to report BMI in kg/m^2
Child weight
weight in kg or lbs
Child height
height in meters or feet

Full Information

First Posted
July 31, 2020
Last Updated
April 3, 2023
Sponsor
Children's Hospital Los Angeles
Collaborators
University of Southern California, Tufts Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04516252
Brief Title
Enhancing BodyWorks: A Canine Health Literacy Module
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2021 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Los Angeles
Collaborators
University of Southern California, Tufts Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Overweight Adolescents
Keywords
Overweight, Obesity, children, adolescents, comprehensive family lifestyle intervention program, telehealth, BodyWorks, Human Animal Interaction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BodyWorks Intervention
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Canine Curriculum
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Ecological Momentary Assessment
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Trackers
Intervention Description
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 Outcome Measure Information:
Title
Variability associated with the BodyWorks + Canine Health Literacy intervention
Description
Determining the mean difference between the groups' variability in the physical activity and ecological momentary assessment outcomes.
Time Frame
Change from baseline weight at 8 weeks
Title
Feasibility of Ecological Momentary Assessment
Description
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.
Time Frame
Weeks 1, 4, 7 of intervention
Title
Acceptability of Ecological Momentary Assessment
Description
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.
Time Frame
Week 8 of intervention
Title
Feasibility of use of physical activity trackers
Description
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.
Time Frame
Weeks 1-8 of intervention
Title
Acceptability of use of physical activity trackers
Description
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.
Time Frame
Week 8 of intervention
Title
Physical activity for adolescents
Description
Number of steps per day
Time Frame
daily for 8 weeks
Title
Physical activity for parents
Description
Number of steps per day
Time Frame
daily for 8 weeks
Title
Physical activity for dogs
Description
Number of steps per day
Time Frame
daily for 8 weeks
Title
Ecological Momentary assessments of adolescents
Description
Each adolescent's affect ratings measured by ecological momentary assessments, administered by mobile phone prompts.
Time Frame
Week 1, 4, 7
Secondary Outcome Measure Information:
Title
Body Mass index
Description
Weight and height will be combined to report BMI in kg/m^2
Time Frame
Change from baseline weight at 8 weeks
Title
Child weight
Description
weight in kg or lbs
Time Frame
Change from baseline weight at 8 weeks
Title
Child height
Description
height in meters or feet
Time Frame
Change from baseline weight at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Overweight/obese youth ages 9-17 years and their caregivers Own dog Exclusion Criteria: Normal BMI Do not own dog
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olga Solomon, PhD
Phone
323-361-4112
Email
osolomon@chla.usc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis Deavenport-Saman, DrPH
Phone
323-361-2994
Email
adeavenport@chla.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Yin, MD, MSPH
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
AltaMed@CHLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Castro, MPH
Phone
323-229-2736
Email
vcastro@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Larry Yin, MD, MSPH
First Name & Middle Initial & Last Name & Degree
Olga Solomon, PhD
First Name & Middle Initial & Last Name & Degree
Alexis Deavenport-Saman, DrPH
First Name & Middle Initial & Last Name & Degree
Juan Espinoza, MD
First Name & Middle Initial & Last Name & Degree
Tyler Mason, PhD
First Name & Middle Initial & Last Name & Degree
Melissa Wilson, PhD
First Name & Middle Initial & Last Name & Degree
Deborah Linder, DVM

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhancing BodyWorks: A Canine Health Literacy Module

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