Canine Health Education for Adolescent Obesity

(BW Trial)

Overseen By Alexis Deavenport-Saman, DrPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Normal BMI, Do not own dog

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether owning a dog can help families improve health by incorporating a special canine health module into a lifestyle program called BodyWorks. The study focuses on adolescents diagnosed with overweight or obesity, along with their parents, to determine if this approach benefits both the children and their dogs. Participants will be divided into two groups: one will follow the standard BodyWorks program, and the other will include the canine health module. Families with a child aged 9-17 diagnosed as overweight or obese and who own a dog might be a good fit for this trial. As an unphased trial, this study offers families a unique opportunity to explore innovative ways to improve health together.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the BodyWorks program, which includes a dog health education section, helps families with overweight or obese teenagers who have dogs. The program is still under evaluation for its effectiveness and safety, particularly when combining family lifestyle education with dog ownership.

Currently, no specific evidence indicates negative effects from participating in this program. The program teaches families about healthy living and dog care. Since it involves no drugs or medical procedures, it is expected to be safe.

In similar studies, programs with educational lessons and lifestyle changes have generally been safe. Participants often report learning more about health and improving relationships with their pets. However, participants should share any concerns with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique approach to addressing adolescent obesity through family and pet involvement. Unlike standard treatments that focus solely on diet and exercise for the child, this method integrates canine health education, engaging the whole family, including their dogs, in a shared health journey. This holistic approach aims to improve health literacy and create a supportive environment, potentially leading to more sustainable lifestyle changes and better outcomes.

What evidence suggests that this trial's treatments could be effective for adolescent obesity?

Research has shown that the BodyWorks program, used in this trial, is a well-supported family lifestyle plan designed to tackle obesity. Studies indicate it helps families adopt healthier habits. Participants in the intervention group will receive the Canine Health Literacy Module, based on the idea that owning a dog can encourage more physical activity, which is important for managing weight. This new approach focuses on improving the health of both children and their dogs. Early findings suggest that this combination could effectively boost physical activity, making it a promising option for those dealing with obesity. ^{1 2 6 7 8}

Who Is on the Research Team?

Larry Yin, MD, MSPH

Principal Investigator

Children's Hospital Los Angeles

Are You a Good Fit for This Trial?

This trial is for caregivers and their overweight or obese children aged 9-17 who own a dog. It aims to tackle obesity by incorporating dogs into the family's lifestyle changes. Those with a normal BMI or without a dog cannot participate.

Inclusion Criteria

You must have a dog as a pet.

I am between 9 and 17 years old and considered overweight or obese.

I am a caregiver of an overweight child aged 9-17.

Exclusion Criteria

Participants with a normal BMI

You must own a dog to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Orientation

Participants receive an orientation session as part of the BodyWorks program

1 week

1 visit (in-person)

Treatment

Participants engage in the BodyWorks program with the Canine Health Literacy module, using physical activity trackers and ecological momentary assessments

7 weeks

Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in physical activity and affect after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BodyWorks Intervention
• Canine Curriculum
• Ecological Momentary Assessment
• Physical Activity Trackers

Trial Overview The study tests an innovative Canine Health-Literacy module within the BodyWorks program, using tools like physical activity trackers and ecological momentary assessment to improve health behaviors in dog-owning families.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 4 Interventions

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.

Group II: Control Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Tufts Medical Center

Collaborator

Trials

264

Recruited

264,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04516252

Enhancing BodyWorks: a Canine Health Literacy Module Ecological Momentary Assessments (EMA) of physical activity will be conducted using mobile phones for 7 weeks of the BW program, prospectively collecting data ...

2. aucd.org aucd.org/nirs-project?id=56619

Project We utilize BodyWorks, a Comprehensive Behavioral Family Lifestyle Interventions (CBFLI), a national, empirically validated, curriculum-based 7-week program ...

3. aucd.org aucd.org/nirs-project?id=64044

A health literacy module for overweight adolescents and their ... This multi-disciplinary study addresses the challenges of managing overweight and obesity in primary care for a sub-population of adolescents who have at ...

4. withpower.com withpower.com/trial/phase-overweight-1-2021-ecbcc

Canine Health Education for Adolescent Obesity (BW Trial) This trial tests a new approach that adds dog health education to a family lifestyle program for overweight or obese adolescents who own dogs.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11862778/

Participant Compliance With Ecological Momentary ... Research has consistently shown greater PA and less ST being beneficial for several health outcomes for both adolescents and emerging adults including self- ...

6. trialx.com trialx.com/clinical-trials/listings/223979/enhancing-bodyworks-a-canine-health-literacy-module/

Enhancing BodyWorks: A Canine Health Literacy Module This study develops and tests a novel approach to design a Canine Health-Literacy module to enhance a Comprehensive Family Lifestyle ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5539388/

Ecological Momentary Assessment of Physical Activity Participants were aged 43.3 (SD 13.1) years, 51.7% (123/238) were African American, 74.8% (178/238) were overweight or obese, and 63.0% (150/238) ...

8. researchgate.net researchgate.net/publication/230621024_Momentary_Assessment_of_Adults'_Physical_Activity_and_Sedentary_Behavior_Feasibility_and_Validity

(PDF) Momentary Assessment of Adults' Physical Activity ... Methods: Adults (N = 110; 73% female, 30% Hispanic, 62% overweight/obese) completed a 4-day signal-contingent EMA protocol (Saturday–Tuesday) ...