Parks & Pediatrics Fit Together: Translating Knowledge Into Action for Child Obesity Treatment in Partnership With Parks and Recreation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 209
- 试验地点
- 5
- 主要终点
- Proportion of children with 26 hours or more of intervention contact
研究概览
简要总结
The proposed project will test an implementation strategy (the "TrailGuide") for delivering an existing model of pediatric obesity treatment ("Fit Together") that has demonstrated ability to meet published recommendations for improving health outcomes of children with obesity.
详细描述
Evidence-based treatment for childhood obesity exists, yet a fundamental knowledge-to-action gap has significantly limited the uptake of recommendations into clinical practice, particularly in low-income settings. Persistence of this gap represents a large-scale public health threat, as the earliest generation of children living through the obesity epidemic now enters adulthood, they are the first in US history to have a shorter life expectancy than their parents, mainly due to rising rates of obesity-related cancers and cardiovascular disease. A central challenge in delivering recommended treatment is the intensity; ≥26 hours of face-to-face contact are necessary to achieve health benefits and risk reduction. The objective of the proposed project is to develop and test an implementation strategy that pairs primary care pediatric clinics with the municipal Parks and Recreation (P&R) centers to deliver the current treatment recommendations with high fidelity, while allowing while allowing crucial adaptations for the local and cultural context. Using the Fit Together model, the clinical partner provides standard medical treatment for pediatric obesity, while the community partner (typically parks and recreation) provides space facilitating the activity/nutrition sessions specifically for children referred from the clinic, along with their families. Fit Together will be implemented in two new communities in North Carolina, and investigators will study implementation outcomes as well as 12-month patient outcomes. A local cohort has been added in Durham, North Carolina, where their local Fit Together model has re-started their community activity program, and investigators will look at 6-month patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Winston-Salem & Charlotte Cohorts:
- •Inclusion Criteria:
- •Child receives primary care at one of the participating clinics
- •Child age 5-12 years old at the time of enrollment in the study
- •BMI greater than or equal to 95th percentile for age and sex (or greater than or equal to 85th%ile at the discretion of the provider)
- •English- or Spanish-speaking
排除标准
- •Injuries or disabilities preventing physical activity.
- •Inclusion criteria for caregivers:
- •Age 18 or older
- •English or Spanish-speaking
- •Caregiver has smartphone and is willing to download app(s) used in the study
- •Anticipates bringing the child to the program the majority of the time and spends significant time with the child outside of program hours (necessary in order to accurately answer survey questions about child behavior and child participation in the program, and provide feedback about the program)
- •Does not have plans to move out of the area during the duration of the study (12 months)
- •Durham Cohort:
- •Inclusion Criteria:
- •Child is a Healthy Lifestyles patient and has been referred to Bull City Fit
- •Child is 5-12 years old at the time of enrollment in the study Child BMI is greater than or equal to the 95th %ile (An exception may be made if BMI is now below the 95th%ile, but was > 95th%ile at the time they started attending Healthy Lifestyles/Bull City Fit. An exception may also be made if BMI was below the 95th%ile but > 85th%ile and obesity treatment/program participation is clinically indicated (e.g., provider still referred them to Healthy Lifestyles and their HL provider referred them to BCF))
- •Child and parent are English- or Spanish-speaking
- •Child does not have an injury or disability preventing them for engaging in physical activity -- if a child meets this exclusion criteria at the time of referral but is expected to recover/heal (e.g., sprained ankle), they may enroll once healed and cleared to resume physical activity.
- •Caregiver age 18 or older
- •Caregiver anticipates bringing the child to the program the majority of the time and spends significant time with the child outside of program hours
- •Does not have plans to move out of the area during the next 6 months If multiple siblings from one household are eligible and would like to participate, more than one child may be enrolled.
研究组 & 干预措施
Control
Participants in the control arm will receive standard of care obesity treatment from their provider and a healthy cooking magazine mailed to them at a regular interval throughout the duration of their 12 month participation
干预措施: Educational materials (Behavioral)
Fit Together
Participants in the intervention arm will receive standard of care obesity treatment from their provider and be able to participate in the Fit Together program and attend activity sessions throughout the duration of their 12 month participation.
干预措施: Fit Together (Behavioral)
Fit Together - BCF Cohort
Participants in the Fit Together - BCF Cohort arm will receive standard of care obesity treatment at the Duke Healthy Lifestyles clinic and attend Bull City Fit throughout the duration of their 6 month participation
干预措施: Fit Together (Behavioral)
结局指标
主要结局
Proportion of children with 26 hours or more of intervention contact
时间窗: Up to 12 months
Measured by program attendance
Change in percent of the 95th percentile for BMI Collected from clinic records.
时间窗: Baseline, 6 months, and 12 months
Change in child's BMI, based on percent of the 95th percentile, measured using height and weight collected from clinic/medical records
Change in number of combined minutes per day of moderate and vigorous physical activity, as measured by Garmin vivofit4 fitness tracker
时间窗: Baseline up to 12 months
Change in physical activity measured by Garmin vivofit4 fitness tracker
Change in percent of the 95th percentile for BMI Collected from clinic records.
时间窗: Baseline, 3 months, 6 months, and 12 months
Change in child's BMI, based on percent of the 95th percentile, measured using height and weight collected from clinic/medical records
次要结局
- Change in self-report physical activity(Baseline, 6 months, and 12 months)
- Unintended Consequences as measured by adverse events(Up to 12 months)
- Change in diet quality(Baseline, 6 months, 12 months)
- Healthcare utilization(Up to 12 months)
- Change in quality of life(Baseline, 6 months, and 12 months)
- Patient Satisfaction at 6 months(6 months)
- Patient Satisfaction at 12 months(12 months)
- Cost effects(Throughout program implementation duration (approx. 30 months))
- Patient Satisfaction at 3 months(3 months)
- Physical activity during program sessions measured by accelerometer(6 months)