Trial Outcomes & Findings for Enhancing BodyWorks: A Canine Health Literacy Module (NCT NCT04516252)
NCT ID: NCT04516252
Last Updated: 2026-07-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
202 participants
Primary outcome timeframe
Baseline to 7 weeks
Results posted on
2026-07-01
Participant Flow
Participant milestones
| Measure |
Intervention
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.
|
Control
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.
BodyWorks 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)
Ecological 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).
Physical 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.
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
105
|
|
Overall Study
Parents
|
46
|
50
|
|
Overall Study
Adolescents
|
51
|
55
|
|
Overall Study
COMPLETED
|
52
|
41
|
|
Overall Study
NOT COMPLETED
|
45
|
64
|
Reasons for withdrawal
| Measure |
Intervention
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.
|
Control
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.
BodyWorks 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)
Ecological 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).
Physical 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
10
|
8
|
|
Overall Study
Did not complete 3 or more intervention sessions
|
35
|
54
|
Baseline Characteristics
Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
Baseline characteristics by cohort
| Measure |
Intervention
n=97 Participants
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.
BodyWorks 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)
Canine 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.
Ecological 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) Physical 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 and FitBark®, wireless, global positioning systems (GPS)-based personal activity trackers for dogs.
|
Control
n=105 Participants
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.
BodyWorks 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)
Ecological 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).
Physical 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.
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Parents · <=18 years
|
0 Participants
n=46 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
0 Participants
n=50 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
0 Participants
n=96 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
|
Age, Categorical
Parents · Between 18 and 65 years
|
46 Participants
n=46 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
50 Participants
n=50 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
96 Participants
n=96 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
|
Age, Categorical
Parents · >=65 years
|
0 Participants
n=46 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
0 Participants
n=50 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
0 Participants
n=96 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
|
Age, Categorical
Adolescents · <=18 years
|
51 Participants
n=51 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
55 Participants
n=55 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
106 Participants
n=106 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
|
Age, Categorical
Adolescents · Between 18 and 65 years
|
0 Participants
n=51 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
0 Participants
n=55 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
0 Participants
n=106 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
|
Age, Categorical
Adolescents · >=65 years
|
0 Participants
n=51 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
0 Participants
n=55 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
0 Participants
n=106 Participants • Total number of participants in involved. Parents (n=96; 46 intervention, 50 control) and adolescents (n=106; 51 intervention, 55 control) were reported separately.
|
|
Age, Continuous
Parent
|
43.3 years
STANDARD_DEVIATION 6.6 • n=46 Participants • Total parents, adolescents. I group: (46 parents, 51 adolescents); C group: (n= 50 parents, 55 adolescents)
|
39 years
STANDARD_DEVIATION 8.2 • n=50 Participants • Total parents, adolescents. I group: (46 parents, 51 adolescents); C group: (n= 50 parents, 55 adolescents)
|
41.2 years
STANDARD_DEVIATION 7.7 • n=96 Participants • Total parents, adolescents. I group: (46 parents, 51 adolescents); C group: (n= 50 parents, 55 adolescents)
|
|
Age, Continuous
Adolescent
|
12.4 years
STANDARD_DEVIATION 2.3 • n=51 Participants • Total parents, adolescents. I group: (46 parents, 51 adolescents); C group: (n= 50 parents, 55 adolescents)
|
12.4 years
STANDARD_DEVIATION 2.5 • n=55 Participants • Total parents, adolescents. I group: (46 parents, 51 adolescents); C group: (n= 50 parents, 55 adolescents)
|
12.4 years
STANDARD_DEVIATION 2.4 • n=106 Participants • Total parents, adolescents. I group: (46 parents, 51 adolescents); C group: (n= 50 parents, 55 adolescents)
|
|
Sex: Female, Male
Parent · Female
|
41 Participants
n=46 Participants • Baseline characteristics are broken down by parent and adolescent.
|
49 Participants
n=50 Participants • Baseline characteristics are broken down by parent and adolescent.
|
90 Participants
n=96 Participants • Baseline characteristics are broken down by parent and adolescent.
|
|
Sex: Female, Male
Parent · Male
|
5 Participants
n=46 Participants • Baseline characteristics are broken down by parent and adolescent.
|
1 Participants
n=50 Participants • Baseline characteristics are broken down by parent and adolescent.
|
6 Participants
n=96 Participants • Baseline characteristics are broken down by parent and adolescent.
|
|
Sex: Female, Male
Adolescent · Female
|
27 Participants
n=51 Participants • Baseline characteristics are broken down by parent and adolescent.
|
26 Participants
n=55 Participants • Baseline characteristics are broken down by parent and adolescent.
|
53 Participants
n=106 Participants • Baseline characteristics are broken down by parent and adolescent.
|
|
Sex: Female, Male
Adolescent · Male
|
24 Participants
n=51 Participants • Baseline characteristics are broken down by parent and adolescent.
|
29 Participants
n=55 Participants • Baseline characteristics are broken down by parent and adolescent.
|
53 Participants
n=106 Participants • Baseline characteristics are broken down by parent and adolescent.
|
|
Ethnicity (NIH/OMB)
Parent · Hispanic or Latino
|
36 Participants
n=46 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
43 Participants
n=50 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
79 Participants
n=96 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Ethnicity (NIH/OMB)
Parent · Not Hispanic or Latino
|
10 Participants
n=46 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
7 Participants
n=50 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
17 Participants
n=96 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Ethnicity (NIH/OMB)
Parent · Unknown or Not Reported
|
0 Participants
n=46 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
0 Participants
n=50 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
0 Participants
n=96 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Ethnicity (NIH/OMB)
Adolescent · Hispanic or Latino
|
42 Participants
n=51 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
48 Participants
n=55 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
90 Participants
n=106 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Ethnicity (NIH/OMB)
Adolescent · Not Hispanic or Latino
|
9 Participants
n=51 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
7 Participants
n=55 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
16 Participants
n=106 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Ethnicity (NIH/OMB)
Adolescent · Unknown or Not Reported
|
0 Participants
n=51 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
0 Participants
n=55 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
0 Participants
n=106 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Race (NIH/OMB)
Parent · American Indian or Alaska Native
|
0 Participants
n=46 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
1 Participants
n=50 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
1 Participants
n=96 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Race (NIH/OMB)
Parent · Asian
|
3 Participants
n=46 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
0 Participants
n=50 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
3 Participants
n=96 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Race (NIH/OMB)
Parent · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=46 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
0 Participants
n=50 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
0 Participants
n=96 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Race (NIH/OMB)
Parent · Black or African American
|
1 Participants
n=46 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
2 Participants
n=50 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
3 Participants
n=96 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Race (NIH/OMB)
Parent · White
|
39 Participants
n=46 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
46 Participants
n=50 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
85 Participants
n=96 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Race (NIH/OMB)
Parent · More than one race
|
3 Participants
n=46 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
1 Participants
n=50 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
4 Participants
n=96 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Race (NIH/OMB)
Parent · Unknown or Not Reported
|
0 Participants
n=46 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
0 Participants
n=50 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
0 Participants
n=96 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Race (NIH/OMB)
Adolescent · American Indian or Alaska Native
|
0 Participants
n=51 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
0 Participants
n=55 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
0 Participants
n=106 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Race (NIH/OMB)
Adolescent · Asian
|
2 Participants
n=51 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
2 Participants
n=55 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
4 Participants
n=106 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Race (NIH/OMB)
Adolescent · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
0 Participants
n=55 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
0 Participants
n=106 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Race (NIH/OMB)
Adolescent · Black or African American
|
4 Participants
n=51 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
1 Participants
n=55 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
5 Participants
n=106 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Race (NIH/OMB)
Adolescent · White
|
41 Participants
n=51 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
48 Participants
n=55 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
89 Participants
n=106 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Race (NIH/OMB)
Adolescent · More than one race
|
4 Participants
n=51 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
4 Participants
n=55 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
8 Participants
n=106 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Race (NIH/OMB)
Adolescent · Unknown or Not Reported
|
0 Participants
n=51 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
0 Participants
n=55 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
0 Participants
n=106 Participants • Parents and adolescents are broken down. In the baseline, Parents and adolescents are combined.
|
|
Region of Enrollment
United States
|
97 participants
n=97 Participants
|
105 participants
n=105 Participants
|
202 participants
n=202 Participants
|
PRIMARY outcome
Timeframe: Baseline to 7 weeksPopulation: Total parents, adolescents. I group: (12 parents, 16 adolescents); C group: (n= 11 parents, 16 adolescents). Below, the groups are parents and adolescents showed separately. These are participants with \>= 7 days of valid data (\>100 steps per day).
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.
Outcome measures
| Measure |
Intervention
n=28 Participants
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.
BodyWorks 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)
Canine 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.
Ecological 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) Physical 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 and FitBark®, wireless, global positioning systems (GPS)-based personal activity trackers for dogs.
|
Control
n=27 Participants
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.
BodyWorks 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)
Ecological 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).
Physical 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.
|
|---|---|---|
|
Change in Mean Physical Activity Associated With the BodyWorks + Canine Health Literacy Intervention for Parents and Adolescents
Parent
|
-326 Steps per day
Standard Deviation 1,601
|
-388 Steps per day
Standard Deviation 2,828
|
|
Change in Mean Physical Activity Associated With the BodyWorks + Canine Health Literacy Intervention for Parents and Adolescents
Adolescent
|
-170 Steps per day
Standard Deviation 1,444
|
-1,017 Steps per day
Standard Deviation 1,737
|
PRIMARY outcome
Timeframe: Baseline to 7 weeksPopulation: Intervention group: (51 adolescents); Control group: (n= 55 adolescents). Higher values mean higher positive or negative affect.
Determining the mean difference between the groups in the positive and negative affect ecological momentary assessment outcomes.
Outcome measures
| Measure |
Intervention
n=51 Participants
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.
BodyWorks 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)
Canine 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.
Ecological 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) Physical 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 and FitBark®, wireless, global positioning systems (GPS)-based personal activity trackers for dogs.
|
Control
n=55 Participants
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.
BodyWorks 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)
Ecological 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).
Physical 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.
|
|---|---|---|
|
Change From Baseline for Adolescent Affect Variability Associated With the BodyWorks + Canine Health Literacy Intervention.
Positive Affect Scale Total: joyful, cheerful, happy, lively, proud. Range: 1=none to 5=extremely).
|
2.43 units on a scale
Standard Deviation 1.05
|
3.41 units on a scale
Standard Deviation 1.15
|
|
Change From Baseline for Adolescent Affect Variability Associated With the BodyWorks + Canine Health Literacy Intervention.
Negative Affect Scale Total: miserable, mad, afraid, scared, sad. Range: 1=none to 5=extremely).
|
1.25 units on a scale
Standard Deviation .42
|
1.49 units on a scale
Standard Deviation .66
|
PRIMARY outcome
Timeframe: Baseline to week 7Population: Adolescent
Feasibility will be determined by data completeness: Percentage of survey questions answered out of 13 possible questions.
Outcome measures
| Measure |
Intervention
n=51 Participants
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.
BodyWorks 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)
Canine 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.
Ecological 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) Physical 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 and FitBark®, wireless, global positioning systems (GPS)-based personal activity trackers for dogs.
|
Control
n=55 Participants
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.
BodyWorks 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)
Ecological 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).
Physical 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.
|
|---|---|---|
|
Mean Number of Questions Answered for Adolescent Feasibility of Ecological Momentary Assessment
|
27.03 percentage of survey questions
Standard Deviation 31.62
|
34.75 percentage of survey questions
Standard Deviation 32.14
|
PRIMARY outcome
Timeframe: Week 7 of interventionAcceptability will be measured by EMA prompt on physical activity with dog.
Outcome measures
| Measure |
Intervention
n=51 Participants
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.
BodyWorks 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)
Canine 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.
Ecological 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) Physical 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 and FitBark®, wireless, global positioning systems (GPS)-based personal activity trackers for dogs.
|
Control
n=55 Participants
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.
BodyWorks 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)
Ecological 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).
Physical 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.
|
|---|---|---|
|
Number of Adolescents That Responded to Physical Acceptability of Ecological Momentary Assessment
|
51 Participants
|
55 Participants
|
PRIMARY outcome
Timeframe: Baseline to 7 weeksPopulation: Number of adolescents and parents with any fitbit data.
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.
Outcome measures
| Measure |
Intervention
n=38 Participants
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.
BodyWorks 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)
Canine 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.
Ecological 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) Physical 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 and FitBark®, wireless, global positioning systems (GPS)-based personal activity trackers for dogs.
|
Control
n=46 Participants
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.
BodyWorks 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)
Ecological 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).
Physical 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.
|
|---|---|---|
|
Number of Parents and Adolescents Feasibility of Use of Physical Activity Trackers.
Adolescents with fitbit data
|
16 number of participants
|
16 number of participants
|
|
Number of Parents and Adolescents Feasibility of Use of Physical Activity Trackers.
Parents with fitbit data
|
12 number of participants
|
11 number of participants
|
PRIMARY outcome
Timeframe: Week 7 of interventionPopulation: Total parents, adolescents. I group: (46 parents, 51 adolescents); C group: (n= 50 parents, 55 adolescents)
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.
Outcome measures
| Measure |
Intervention
n=97 Participants
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.
BodyWorks 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)
Canine 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.
Ecological 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) Physical 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 and FitBark®, wireless, global positioning systems (GPS)-based personal activity trackers for dogs.
|
Control
n=105 Participants
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.
BodyWorks 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)
Ecological 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).
Physical 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.
|
|---|---|---|
|
Mean Score of Parents and Adolescents Acceptability of Use of Physical Activity Trackers Using Likert Scale.
Parent: Likert -2 (strongly disagree) to 2 (strongly agree)
|
1.21 score on scale -2 to 2
Standard Deviation .8
|
1.28 score on scale -2 to 2
Standard Deviation .59
|
|
Mean Score of Parents and Adolescents Acceptability of Use of Physical Activity Trackers Using Likert Scale.
Adolescent: Likert Scale -2 (strongly disagree) to 2 (strongly agree)
|
1.08 score on scale -2 to 2
Standard Deviation .73
|
1.14 score on scale -2 to 2
Standard Deviation .62
|
PRIMARY outcome
Timeframe: Baseline to 7 weeksPopulation: Total parents, adolescents. I group: (12 parents, 16 adolescents); C group: (n= 11 parents, 16 adolescents). Below, the groups are parents and adolescents showed separately. These are participants with \>= 7 days of valid data (\>100 steps per day).
Number of steps per day
Outcome measures
| Measure |
Intervention
n=28 Participants
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.
BodyWorks 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)
Canine 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.
Ecological 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) Physical 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 and FitBark®, wireless, global positioning systems (GPS)-based personal activity trackers for dogs.
|
Control
n=27 Participants
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.
BodyWorks 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)
Ecological 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).
Physical 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.
|
|---|---|---|
|
Mean Physical Activity for Parent and Adolescent Out of Participants With Fitbit Data.
Parent
|
9487 Steps per day
Standard Deviation 2282
|
7806 Steps per day
Standard Deviation 2788
|
|
Mean Physical Activity for Parent and Adolescent Out of Participants With Fitbit Data.
Adolescent
|
7784 Steps per day
Standard Deviation 2368
|
8153 Steps per day
Standard Deviation 3076
|
SECONDARY outcome
Timeframe: Baseline to 7 weeksWeight and height will be used to calculate BMI in kg/m\^2
Outcome measures
| Measure |
Intervention
n=51 Participants
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.
BodyWorks 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)
Canine 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.
Ecological 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) Physical 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 and FitBark®, wireless, global positioning systems (GPS)-based personal activity trackers for dogs.
|
Control
n=55 Participants
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.
BodyWorks 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)
Ecological 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).
Physical 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.
|
|---|---|---|
|
Change in Body Mass Index From Baseline for Adolescent
|
-.67 kg/m^2
Standard Deviation 3.64
|
.24 kg/m^2
Standard Deviation 2.97
|
Adverse Events
Parent Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parent Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adolescent Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adolescent Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Larry Yin
Children's Hospital Los Angeles; USC Keck School of Medicine
Phone: 3236692110
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place