Applying Navigation and Care to Help Ongoing Retention (ANCHOR): The ANCHOR Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Attrition
研究概览
简要总结
Canada's health care system has established numerous clinics over the past 20 years to treat childhood obesity. However, up to 80% of children at these clinics drop out before they finish treatment. This is one of the most difficult challenges in managing childhood obesity, since even the most effective treatments cannot help children who drop out. However, children who stay in treatment longer are more likely to manage obesity successfully. This randomized controlled trial will test whether Family Navigation (FN) helps reduce drop out from obesity treatment. Overall, this study will last 5 years. The investigators will enroll 252 children aged 6 to 17 with obesity. These children will receive treatment at obesity management clinics in Calgary, Mississauga, or Ottawa. For the 24-month intervention period, one group of children (half of those enrolled) will receive FN + Usual Care; the other group will receive only Usual Care. Navigators trained in motivational interviewing and bias/stigma reduction will work with children receiving FN and their families to overcome barriers that limit their access to health services and support. Navigators will offer additional services and resources, such as parking passes for clinic visits and supportive text messages between appointments. FN is designed to support the obesity management care received by children and their families. Better access to care may help children and their families working with navigators to stay engaged and attend more treatment appointments. Ultimately, they may be more likely to succeed in managing obesity.
详细描述
Background: Pediatric obesity is common and complex. Pediatric obesity management (POM) can be successful, but most children need to receive a moderate to high intervention dose to improve obesity and health outcomes. Up to 80% of children in POM experience attrition (permanently), reducing treatment impact. Barriers are the most common reason for attrition, limiting family access to POM. Family Navigation (FN) is a strategy that supports families and improves health care access, satisfaction, and outcomes in other areas but is untested in POM.
Objectives: The primary objective is to examine the effectiveness of FN to reduce attrition in POM. The secondary objectives are to determine intervention effects on clinical and health services outcomes, compare the cost-effectiveness of experimental vs control groups, and complete a process evaluation to explore factors that impact FN implementation.
Trial Design: This trial is a multicenter, multimethod, hybrid type 1 effectiveness-implementation RCT, to concurrently test the effectiveness of a clinical intervention and identify enablers and barriers in real-world use. This 5-year trial has 2 arms - experimental (FN + Usual Care) and control (Usual Care only) with parallel assignment (1:1). Data analysts and POM clinicians will be blinded to group assignment. Children will be assigned to the experimental or control group after enrolling in multidisciplinary POM clinics in Calgary, Mississauga, or Ottawa.
Trial Interventions. The experimental group will receive FN + Usual Care. The control group will receive Usual Care only.
Developing FN: The FN intervention was co-designed as part of the investigators' feasibility RCT drawing on Experience-Based Co-Design to understand health service experiences, identify potential improvements, and make changes collaboratively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be 6-17 years old,
- •have a BMI ≥97th percentile,
- •have a primary caregiver (parent/guardian) agree to participate
排除标准
- •participants will be excluded if caregivers cannot communicate in English since the Family Navigation intervention will be available in English only.
研究组 & 干预措施
Family Navigation + Usual Care
Participants assigned to this arm will receive the Family Navigation (FN) intervention in addition to standard pediatric obesity management (Usual Care).
干预措施: Family Navigation (Behavioral)
Family Navigation + Usual Care
Participants assigned to this arm will receive the Family Navigation (FN) intervention in addition to standard pediatric obesity management (Usual Care).
干预措施: Usual Care (Behavioral)
Usual Care
Participants assigned to this arm will standard pediatric obesity management only.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Attrition
时间窗: 24 months post-baseline
Complementing the investigators' conceptual definition of attrition (permanent discontinuation of care), the operational definition includes "yes" and "no" categories. Attrition will be recorded identically for experimental (FN + Usual Care) and control (Usual Care only) groups at all 3 sites. A child will be classified as "yes" if they discontinue POM within 24 months post-baseline or miss/cancel an appointment without rescheduling, and the clinic has no follow-up with the family after 4 communication attempts over 4 weeks and no upcoming appointments scheduled. A child in POM at 24-months post-baseline will be classified as "no." Attrition will be marked as the exact date of a child's last recorded interaction with a POM clinician or navigator, confirmed using primary (medical records, scheduling system) and secondary (families, POM clinicians, navigators \[experimental group only\]) sources.
次要结局
- Sociodemographic Data(Baseline)
- Anthropometrics(At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline)
- Health-related Quality of Life (PedsQL 4.0)(At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline)
- Health-related Quality of Life (HUI-3)(At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline)
- Internalized and Experienced Weight Bias(At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline)
- Strength of Therapy Relationship Between Caregivers and Navigators/Clinicians(At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline)
- Pediatric Obesity Management Influence on Children's Perceived Health(At 0- (baseline), 6-, 12-, 18-, and 24-months post-baseline)
- Quality of Care Received(At 6-, 12-, 18-, and 24-months post-baseline)
- Unintended Consequences(At 6-, 12-, 18-, and 24-months post-baseline)
- Health Services Usage(At 6-, 12-, 18-, and 24-months post-baseline)
- Incremental cost per quality adjusted life years (QALYs) gained(At 6-, 12-, 18-, and 24-months post-baseline)
- Intervention Implementation(12- and 24-months post-baseline)