Attrition in Pediatric Obesity Management: A Randomized Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Perceived acceptability of Family Navigation (Child)
研究概览
简要总结
Our feasibility study will assess the feasibility and acceptability of Family Navigation (FN) to address attrition (dropout) in pediatric obesity management. Results from this study will help our team to plan a large randomized clinical trial to test the effectiveness of FN in reducing attrition.
The investigators will enroll 108 6-to-17-year-olds enrolled in pediatric obesity management clinics in Calgary, AB and Mississauga, ON (Canada). One-half of the children will receive Family Navigation (FN) + Usual Care (UC) for 12 months; the other half will receive Usual Care only for 12 months. Overall, the study will take 2.5 years to complete.
For children receiving FN, trained navigators will work with children and their families to reduce barriers that limit their access to health services and support. Navigators will offer extra services and resources, such as parking passes for clinic appointments and supportive text messages between appointments. FN is designed to complement the obesity management (Usual Care) received by children and their families. A Steering Committee with children, caregivers, clinicians, and researchers will be created to refine and improve our FN intervention throughout the study.
By having better access to care, children and their families working with navigators may be less likely to drop out and more likely to attend more treatment appointments. Ultimately, the participants may be more likely to achieve success in managing obesity.
详细描述
Background: Pediatric obesity is prevalent, persistent, and complex. Annual obesity-linked healthcare costs in Canada exceed $7 billion. For people living with obesity, successful obesity management (i.e., reducing or stabilizing weight gain, improving obesity-related consequences) is challenging. Without intervention, obesity and its consequences usually track into adulthood, a pattern that entrenches with increasing obesity severity, underscoring the high value of accessible and effective interventions. Robust evidence demonstrates that multidisciplinary interventions centered on family lifestyle and behavior can help children to manage obesity. However, success is predicted by adhering to treatment regimens, including regularly attending clinical appointments. Effective lifestyle and behavioral interventions require a moderate to high intervention dose (>25 hours of clinic contact over 6-12 months) to optimize benefits (↓BMI, systolic blood pressure; ↑insulin sensitivity, quality of life). Achieving this dose is difficult for families in pediatric obesity management (POM) because many experience barriers and constraints to accessing care, such as schedule availability, transportation costs, and variable motivation. Even the best obesity management interventions are undermined when families discontinue care prematurely. To meet this mandate, the proposed research tackles a common and vexing issue in POM - Attrition.
Purpose: The purpose of this feasibility study is to prepare the study team for a definitive RCT in which the investigators will test the effectiveness of a novel intervention (Family Navigation [FN]) to reduce attrition in 6-17 years old in pediatric obesity management (POM).
Objectives: The primary objectives of the study are to 1) assess children's and caregivers' perceived acceptability of the FN intervention and 2) evaluate attrition and measures of study rigor and conduct, including participant recruitment and enrolment, randomization procedures, and study protocol integrity, against pre-set success indicators. The study's secondary objective is to collect various outcomes (clinical, health services, economics) with established or possible links to attrition for descriptive purposes and hypothesis generation.
Trial Design: The trial is a 2.5-year, multi-method, multi-center randomized feasibility study that has 2 arms and follows parallel assignment. Children will be assigned to an experimental or control group after they enroll in multidisciplinary POM clinics in Calgary, AB and Mississauga, ON (Canada).
Trial Interventions: The experimental group will receive FN + Usual Care. FN will be co-designed to reduce attrition by managing barriers and eliminating constraints that limit access to care. FN increases access to a moderate to high intervention dose, increasing success in POM. The control group will receive Usual Care only (delivered similarly in the 2 study clinics).
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)
盲法说明
Study investigators will not know which families were randomized to the experimental group or control group. Data analyses, both quantitative and qualitative, will be led by investigators who will have no direct contact with families and will not have access to information regarding group assignment. Interventions will be delivered by Family Navigators and data collection will be completed by research team members, although both groups will be aware of families' group assignments.
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.
结局指标
主要结局
Perceived acceptability of Family Navigation (Child)
时间窗: 3, 6, and 12 months post-baseline
The investigators will complete semi-structured, 1-on-1 interviews with children using appropriate interview guides. Guides are based on multiple domains of intervention acceptability according to the Theoretical Framework of Acceptability, which includes multiple component constructs. Our sampling uses age as a proxy for developmental stage (6-9y; 10-13y; 14-17y). Groupings were based on developmental differences that could influence participants' perceptions and experiences of the Family Navigation intervention. Children from (10-13y) and (14-17y) age groups will be interviewed. For the 6-9y group, no children will be interviewed; however, their caregivers will be interviewed. Interviews will be recorded, undergo voice-to-text conversion, or be transcribed verbatim. Perceived acceptability among children will be measured in a sub-set of the families in the FN + UC group.
Perceived acceptability of Family Navigation (Caregiver)
时间窗: 3, 6, and 12 months post-baseline
The investigators will complete semi-structured, 1-on-1 interviews with caregivers, using interview guides that are appropriate for them. Guides are based on multiple domains of intervention acceptability according to the Theoretical Framework of Acceptability, which includes multiple component constructs. Sampling for caregivers' interviews will be performed considering their children's age group. Our sampling uses the age of the children as a proxy for developmental stage (6-9y; 10-13y; 14-17y). Groupings were based on developmental differences that could influence participants' perceptions and experiences of the Family Navigation intervention. Interviews will be recorded, undergo voice-to-text conversion, or be transcribed verbatim. Perceived acceptability among children will be measured in a sub-set of the families in the FN + UC group.
次要结局
- Sociodemographic data(Baseline)
- Measures of study rigor and conduct(Baseline)
- Child- and caregiver-reported internalized and experienced weight bias(Baseline, 3, 6, and 12 months post-baseline)
- Family treatment expectations for obesity management(Baseline)
- Child and caregiver motivation to change lifestyle habits(Baseline, 3, 6, and 12 months post-baseline)
- PedsQL Healthcare Satisfaction(Baseline, 3, 6, and 12 months post-baseline)
- Attrition(3, 6, and 12 months post-baseline)
- Working Alliance Inventory(Baseline, 3, 6, and 12 months post-baseline)
- PedsQL(Baseline, 3, 6, and 12 months post-baseline)
- Unintended consequences of treatment(Baseline, 3, 6, and 12 months post-baseline)