Overweight and ObesityBWNCT04516252
Enhancing BodyWorks: A Canine Health Literacy Module
A study testing BodyWorks Intervention, Canine Curriculum and Ecological Momentary Assessment in people with Overweight and Obesity and Overweight Adolescents, run by Children's Hospital Los Angeles at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Overweight and Obesity, Overweight Adolescents
- What is being tested?
- BodyWorks Intervention, Canine Curriculum and Ecological Momentary Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2021to 13 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Overweight/obese youth ages 9-17 years and their caregivers
- Own dog
Who cannot join
- Normal BMI
- Do not own dog
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Overweight and Obesity, Overweight Adolescents
- Being tested
- BodyWorks Intervention, Canine Curriculum, Ecological Momentary Assessment, Physical Activity Trackers
- Keywords
- Overweight, Obesity, children, adolescents, comprehensive family lifestyle intervention program, telehealth, BodyWorks, Human Animal Interaction
- Medical subject headings
- Overweight, Obesity, Human-Animal Interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BodyWorks InterventionBehavioural
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 CurriculumBehavioural
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 AssessmentBehavioural
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 TrackersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: BodyWorks Intervention; Behavioral: Ecological Momentary Assessment; Behavioral: Physical Activity Trackers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Physical Activity Associated With the BodyWorks + Canine Health Literacy Intervention for Parents and Adolescents
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.
Measured: Baseline to 7 weeks
Change From Baseline for Adolescent 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.
Measured: Baseline to 7 weeks
Mean Number of Questions Answered for Adolescent Feasibility of Ecological Momentary Assessment
Feasibility will be determined by data completeness: Percentage of survey questions answered out of 13 possible questions.
Measured: Baseline to week 7
Number of Adolescents That Responded to Physical Acceptability of Ecological Momentary Assessment
Acceptability will be measured by EMA prompt on physical activity with dog.
Measured: Week 7 of intervention
Number of Parents and Adolescents Feasibility of Use of Physical Activity Trackers.
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.
Measured: Baseline to 7 weeks
Mean Score of Parents and Adolescents Acceptability of Use of Physical Activity Trackers Using Likert Scale.
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.
Measured: Week 7 of intervention
Mean Physical Activity for Parent and Adolescent Out of Participants With Fitbit Data.
Number of steps per day
Measured: Baseline to 7 weeks
Secondary outcomes (1)
Change in Body Mass Index From Baseline for Adolescent
Weight and height will be used to calculate BMI in kg/m^2
Measured: Baseline to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start27 Feb 2021
- Primary completion13 Jan 2025
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Tufts Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Larry Yin, Children's Hospital Los Angeles
- Investigators
- Larry Yin, MD, MSPH, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516252
- Sponsor's protocol ID
- CHLA-CG-19-00001
- Other IDs
- R21HD097761
- Acronym
- BW
- Status last verified
- Jun 2026
- First submitted
- 31 Jul 2020
- Last updated
- 1 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04516252
- Acronym / sponsor ID
- BW / CHLA-CG-19-00001
- Conditions
- Overweight and Obesity, Overweight Adolescents
- Keywords
- Overweight, Obesity, children, adolescents, comprehensive family lifestyle intervention program, telehealth, BodyWorks, Human Animal Interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- University of Southern California, Tufts Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 27 Feb 2021 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Posted 1 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: BodyWorks Intervention, Behavioral: Canine Curriculum, Behavioral: Ecological Momentary Assessment, Behavioral: Physical Activity TrackersHalf 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. |
| Control | Active comparator | Behavioral: BodyWorks Intervention, Behavioral: Ecological Momentary Assessment, Behavioral: Physical Activity TrackersHalf 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. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Overweight/obese youth ages 9-17 years and their caregivers
- Own dog
Key exclusion criteria (2 listed)
- Normal BMI
- Do not own dog
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BodyWorks InterventionBodyWorks (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) | Behavioural | Control, Intervention |
| Canine CurriculumUsing 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. | Behavioural | Intervention |
| Ecological Momentary AssessmentEcological 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). | Behavioural | Control, Intervention |
| Physical Activity TrackersThree 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. | Behavioural | Control, Intervention |
Primary outcome
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.
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.
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.
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.
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.
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.
Mean Physical Activity for Parent and Adolescent Out of Participants With Fitbit Data.
Time frame: Baseline to 7 weeks
Number of steps per day
1 secondary outcome
Change in Body Mass Index From Baseline for Adolescent
Time frame: Baseline to 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry Yin, MD, MSPH principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BodyWorks Intervention, Canine Curriculum and Ecological Momentary Assessment in people with Overweight and Obesity and Overweight Adolescents, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Physical Activity Associated With the BodyWorks + Canine Health Literacy Intervention for Parents and Adolescents (time frame: Baseline to 7 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.