Foundations of Fitness: A Clinic-Community Partnership to Address Pediatric Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Program Feasibility based on program attendance and completion of assessments to determine if children are willing and interested in to attending a fitness program.
研究概览
简要总结
Approximately 17% of US children have obesity resulting in significant childhood co-morbidities and increased lifetime risk of adult obesity, diabetes, cardiovascular disease and cancer. Guidelines recommend intensive lifestyle programs as first-line treatment, yet few pediatric practices are equipped to provide this. Clinical-community partnerships are well-positioned to address this care gap. This proposal aims to assess whether a community-delivered lifestyle program offered in adjunct to primary care obesity management is feasible, acceptable, effective, and easily implemented in a rural care setting. In this study, approximately 40 children aged 7-13 years old and their caregiver pairs will be recruited from a primary care pediatric clinic. Child-adult dyads will participate in a 24-week program that includes 2 phases, a 12-week usual care phase and a 12-week intervention phase. The intervention phase will include bi-weekly meetings of a community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change. A mixed-methods approach using qualitative interviews and study questionnaires, combined with objective measures of adiposity and fitness will assess study 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
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 7-13 years;
- •BMI% ≥85th%;
- •Regional pediatric medical home patient;
- •English speaking child and parent/caregiver;
排除标准
- •Physical or developmental limitation to participation as determined by referring provider
研究组 & 干预措施
7-10 years old
Children-caregiver pairs will participate in a 24-week pilot that includes 2 phases, 12 weeks of usual care, followed by 12 weeks of Foundations of Fitness Program.
干预措施: Foundations of Fitness Program (Other)
11-13 years old
Children-caregiver pairs will participate in a 24-week pilot that includes 2 phases, 12 weeks of usual care, followed by 12 weeks of Foundations of Fitness Program.
干预措施: Foundations of Fitness Program (Other)
结局指标
主要结局
Program Feasibility based on program attendance and completion of assessments to determine if children are willing and interested in to attending a fitness program.
时间窗: 24 weeks
Programmatic feasibility will be defined as delivery of 100% of the sessions with 80% of children attending ≥75% of sessions and 80% completing pre- and post-assessments.
Program Acceptability based on interviews evaluating the appropriateness of the pilot and assessing strengths/weaknesses.
时间窗: 24 weeks
Program acceptability will be assessed through semi-structured participant interviews ensuring the appropriateness of the pilot and assessing strengths/weaknesses.
Program Eligibility rate
时间窗: 24 weeks
Calculated using the following formula: \[# screen positive / # screened for inclusion\].
Program Enrollment rate
时间窗: 24 weeks
Calculated using the following formula: \[# enrolled / (# screen positive \& eligible)\]. We will assess reasons for dropout/non-adherence.
Program Completion rate
时间窗: 24 weeks
Calculated using the following formula: (# completing all sessions / # enrolled).
Assessment Completion rate
时间窗: 24 weeks
Calculated using the following formula: (# completing all assessments / # enrolled).
Participant Satisfaction Survey
时间窗: 24 weeks
A 12 item survey at program conclusion will assess patient satisfaction with program elements (overall, class sessions, staff, assessments) using Likert scales (1-5 point scale - very dissatisfied=1 to very satisfied=5).
次要结局
- Body Mass Index Percentile(48 weeks)
- Health Habits Survey(24 weeks)
- Strength Assessment(24 weeks)
- Subjective Health and Quality of Life Score(24 weeks)
- Heart Rate(24 weeks)
- Waist Circumference(24 weeks)
- Perceived Athletic Competence Score(24 weeks)
- Cardio-capacity(24 weeks)
- Sense of Belonging in Fitness Program Score(24 weeks)
- Self Esteem Score(24 weeks)
- Physical Activity Score(24 weeks)
- Blood Pressure(24 weeks)
研究者
Auden McClure
Staff Physician
Dartmouth-Hitchcock Medical Center