Overweight Adolescents, Overweight and Obesity
Conditions
Keywords
Overweight, Obesity, children, adolescents, comprehensive family lifestyle intervention program, telehealth, BodyWorks, Human Animal Interaction
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.
Interventions
BEHAVIORALBodyWorks Intervention
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)
BEHAVIORALCanine Curriculum
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.
BEHAVIORALEcological Momentary Assessment
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).
BEHAVIORALPhysical Activity Trackers
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.
Sponsors
Children's Hospital Los Angeles
University of Southern California
Tufts Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Overweight/obese youth ages 9-17 years and their caregivers * Own dog
Exclusion criteria
* Normal BMI * Do not own dog
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Parents and Adolescents Feasibility of Use of Physical Activity Trackers. | 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 Physical Activity for Parent and Adolescent Out of Participants With Fitbit Data. | Baseline to 7 weeks | Number of steps per day |
| Mean Score of Parents and Adolescents Acceptability of Use of Physical Activity Trackers Using Likert Scale. | 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. |
| Change in Mean Physical Activity Associated With the BodyWorks + Canine Health Literacy Intervention for Parents and Adolescents | 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. | 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 | 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 | Week 7 of intervention | Acceptability will be measured by EMA prompt on physical activity with dog. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index From Baseline for Adolescent | Baseline to 7 weeks | Weight and height will be used to calculate BMI in kg/m\^2 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLarry Yin, MD, MSPH
Children's Hospital Los Angeles
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical Adolescents <=18 years | 106 Participants |
| Age, Categorical Adolescents >=65 years | 0 Participants |
| Age, Categorical Adolescents Between 18 and 65 years | 0 Participants |
| Age, Categorical Parents <=18 years | 0 Participants |
| Age, Categorical Parents >=65 years | 0 Participants |
| Age, Categorical Parents Between 18 and 65 years | 50 Participants |
| Age, Continuous Adolescent | 12.4 years STANDARD_DEVIATION 2.5 |
| Age, Continuous Parent | 43.3 years STANDARD_DEVIATION 6.6 |
| Ethnicity (NIH/OMB) Adolescent Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Adolescent Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Adolescent Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Parent Hispanic or Latino | 79 Participants |
| Ethnicity (NIH/OMB) Parent Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Parent Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Adolescent American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Adolescent Asian | 2 Participants |
| Race (NIH/OMB) Adolescent Black or African American | 4 Participants |
| Race (NIH/OMB) Adolescent More than one race | 4 Participants |
| Race (NIH/OMB) Adolescent Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Adolescent Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Adolescent White | 89 Participants |
| Race (NIH/OMB) Parent American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Parent Asian | 3 Participants |
| Race (NIH/OMB) Parent Black or African American | 2 Participants |
| Race (NIH/OMB) Parent More than one race | 4 Participants |
| Race (NIH/OMB) Parent Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Parent Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Parent White | 46 Participants |
| Region of Enrollment United States | 97 participants |
| Sex: Female, Male Adolescent Female | 26 Participants |
| Sex: Female, Male Adolescent Male | 24 Participants |
| Sex: Female, Male Parent Female | 49 Participants |
| Sex: Female, Male Parent Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 50 | 0 / 51 | 0 / 55 |
| other Total, other adverse events | 0 / 46 | 0 / 50 | 0 / 51 | 0 / 55 |
| serious Total, serious adverse events | 0 / 46 | 0 / 50 | 0 / 51 | 0 / 55 |
Outcome results
None listed