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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Physical Activity Variability associated with the BodyWorks + Canine Health Literacy intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight/obese youth ages 9-17 years and their caregivers
排除标准
- •Normal BMI
- •Do not own dog
研究组 & 干预措施
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.
干预措施: BodyWorks Intervention (Behavioral)
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.
干预措施: Canine Curriculum (Behavioral)
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.
干预措施: Ecological Momentary Assessment (Behavioral)
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.
干预措施: Physical Activity Trackers (Behavioral)
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.
干预措施: BodyWorks Intervention (Behavioral)
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.
干预措施: Ecological Momentary Assessment (Behavioral)
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.
干预措施: Physical Activity Trackers (Behavioral)
结局指标
主要结局
Physical Activity Variability associated with the BodyWorks + Canine Health Literacy intervention
时间窗: Change from baseline physical activity at 7 weeks
Determining the mean difference between groups in the physical activity outcomes for number of steps per day as measured by the physical activity tracker
Affect Variability associated with the BodyWorks + Canine Health Literacy intervention
时间窗: Change from baseline affect at 7 weeks
Determining the mean difference between the groups in the positive and negative affect ecological momentary assessment outcomes.
Feasibility of Ecological Momentary Assessment
时间窗: Weeks 1, 4, 7 of intervention
Feasibility will be determined by data completeness: Ratio of questions answered during a wave to total number of possible questions.
Acceptability of Ecological Momentary Assessment
时间窗: Week 7 of intervention
Acceptability will be measured by EMA prompt response rate out of the total possible responses.
Feasibility of use of physical activity trackers
时间窗: Weeks 1-7 of intervention
Feasibility will be determined by data completeness: Ratio of days on which there are valid fitbit data out of the total number of days in terms of steps per day and minutes per day.
Acceptability of use of physical activity trackers
时间窗: Week 7 of intervention
Acceptability will be measured by response rate on user satisfaction survey.
Physical activity for adolescents
时间窗: daily for 7 weeks
Number of steps per day
Physical activity for parents
时间窗: daily for 7 weeks
Number of steps per day
Physical activity for dogs
时间窗: daily for 7 weeks
Number of steps per day
Ecological Momentary assessments of adolescents
时间窗: Weeks 1, 4, 7
Mean adolescent affect ratings measured by ecological momentary assessments administered via text messages
Change in Mean Physical Activity Associated With the BodyWorks + Canine Health Literacy Intervention for Parents and Adolescents
时间窗: 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.
时间窗: 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
时间窗: 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
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: Baseline to 7 weeks
Number of steps per day
次要结局
- Body Mass index(Change from baseline BMI at 7 weeks)
- Change in Body Mass Index From Baseline for Adolescent(Baseline to 7 weeks)
研究者
Larry Yin
Associate Professor of Clinical Pediatrics
Children's Hospital Los Angeles