Enhancing BodyWorks: a Canine Health Literacy Module

NCT04516252 | Active Not Recruiting DMC

• 2 other identifiers: CHLA-CG-19-00001R21HD097761
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Overweight Adolescents

Keywords

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

Outcome Measures

Primary Outcomes (10)

• Physical Activity Variability associated with the BodyWorks + Canine Health Literacy intervention

  Determining the mean difference between groups in the physical activity outcomes for number of steps per day as measured by the physical activity tracker

  Change from baseline physical activity at 7 weeks

• Affect Variability associated with the BodyWorks + Canine Health Literacy intervention

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

  Change from baseline affect at 7 weeks

• Feasibility of Ecological Momentary Assessment

  Feasibility will be determined by data completeness: Ratio of questions answered during a wave to total number of possible questions.

  Weeks 1, 4, 7 of intervention

• Acceptability of Ecological Momentary Assessment

  Acceptability will be measured by EMA prompt response rate out of the total possible responses.

  Week 7 of intervention

• Feasibility of use of physical activity trackers

  Feasibility 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.

  Weeks 1-7 of intervention

• Acceptability of use of physical activity trackers

  Acceptability will be measured by response rate on user satisfaction survey.

  Week 7 of intervention

• Physical activity for adolescents

  Number of steps per day

  daily for 7 weeks

• Physical activity for parents

  Number of steps per day

  daily for 7 weeks

• Physical activity for dogs

  Number of steps per day

  daily for 7 weeks

• Ecological Momentary assessments of adolescents

  Mean adolescent affect ratings measured by ecological momentary assessments administered via text messages

  Weeks 1, 4, 7

Secondary Outcomes (1)

• Body Mass index

  Change from baseline BMI at 7 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: BodyWorks Intervention; Behavioral: Canine Curriculum; Behavioral: Ecological Momentary Assessment; Behavioral: Physical Activity Trackers

Control

ACTIVE COMPARATOR

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.

Behavioral: BodyWorks Intervention; Behavioral: Ecological Momentary Assessment; Behavioral: Physical Activity Trackers

Interventions

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)

Control; Intervention

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.

Intervention

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).

Control; Intervention

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.

Control; Intervention

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Normal BMI
• Do not own dog

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• University of Southern California: collaborator
• Tufts Medical Center: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

AltaMed@CHLA

Los Angeles, California, 90057, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Human-Animal Interaction

Interventions

Ecological Momentary Assessment; Fitness Trackers

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Study Officials

• Larry Yin, MD, MSPH

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 18, 2020
• Study Start: February 27, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)