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临床试验/NCT02573142
NCT02573142已完成不适用

A Novel Healthcare-Community Partnership for Childhood Obesity Treatment: A Randomized Pilot Study

Duke University2 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
2
主要终点
Change in Body Mass Index

研究概览

简要总结

The primary aim of this study is to reduce body mass index (BMI) among children ages 5-11 who are obese by integrating behavioral treatment strategies in both clinic (Healthy Lifestyles) and community (Bull City Fit) settings. A two-group randomized, controlled, non-blinded pilot design will be utilized. The intended target population is the adult caregiver and a child with obesity (BMI ≥ 95th percentile) aged 5-11. The intervention condition will be standard care with Healthy Lifestyles programming plus Bull City Fit; upcoming activities will be texted to the parents mobile device using GoogleVoice. The control condition will be standard clinical care with Healthy Lifestyles programming. Primary outcome is BMI at 6 months. Secondary outcomes include anthropometric, psychosocial, and reported health behaviors.

详细描述

Prevention strategies have made important strides to stabilize obesity prevalence, however US childhood obesity prevalence remains high (17%) and effective treatment has been elusive. Furthermore, children with severe obesity continues to increase, especially among Hispanics and African Americans. These children have increased cardio-metabolic risks and comorbidities, and healthcare costs are concentrated among them. It is critical to identify effective interventions that can be made widely available for low-income, diverse populations in order to mitigate economic and societal costs.

High-intensity behavioral treatment interventions in specialized clinical research settings have been shown to be modestly effective.Effects tend to be small, short-term, and difficult to replicate in "real-world" clinical settings. Community-based settings (e.g., recreation centers) offer an attractive setting to deliver treatment. Community centers are locally accessible, can offer activities during evenings and on weekends, and provide relaxed environments that support social interaction. However, community-based interventions cannot provide the patient-centered medical care and individual nutrition counseling currently recommended for obesity treatment. New recommendations encourage linking clinical treatment with community resources, yet evidence demonstrating the feasibility and efficacy of such interventions is limited.

Locally, the investigators have developed both a specialized clinical obesity treatment program as well as a community based treatment program, and have linked the two via a shared use agreement. The innovative model provides multidisciplinary, individualized behavioral modification counseling and support through the clinic-based Healthy Lifestyles program, and higher intensity social and environmental support to reinforce behavior change through Bull City Fit programming.

The clinical program, Duke Children's Healthy Lifestyles (HL), is a comprehensive (AAP Stage 2-4) childhood obesity treatment program that has served primarily low-income African American and Hispanic families since 2006. In short, children aged 22 years and under with BMI ≥ 95th percentile (i.e., obese) are referred by their primary physician to the multidisciplinary Healthy Lifestyles clinic for treatment of obesity and related co-morbidities. The intervention involves monthly visits for one year to meet with medical, dietary, exercise and behavior specialists all certified in Motivational Interviewing. Similar to other interventions delivered through primary care settings, the Healthy Lifestyles model alone leads to measurable but not clinically significant decreases in body mass index.

The community-based program, Bull City Fit (BCF), was developed in 2012 by HL staff to increase intensity of the clinical intervention. The community center is a Durham Parks and Recreation (PR) facility. The investigators chose this municipal partner due to potential scalability of the intervention; over 5,000 PR facilities exist nationwide and every American lives within a 20 mile radius of a PR facility (DPR.gov). Bull City Fit provides free access to Edison Johnson Community Center, including 2 hours of staffed programming six days a week designed specifically for Healthy Lifestyles patients aged 2-18 and their families. This includes sports, games, cooking classes, gardening, parent support groups, teen support groups, and developmentally appropriate activities for all ages. With guidance from Healthy Lifestyles clinic providers, Bull City Fit programming is run by trained volunteers who are primarily Duke University students, pediatric residents, and community members invested in the wellness of families in their city.

研究设计

研究类型
Interventional
分配方式
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 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Adult aged 18 or older and is the child's primary caregiver ("parent")
  • Child aged 5-11 years
  • Child with age- and gender-specific BMI ≥ 95th percentile

排除标准

  • Inability to read and write in English
  • Family currently has paid membership to a gym or fitness center
  • Parent with severe medical or mental health condition limiting ability to attend appointments
  • Child with severe medical or mental health condition limiting ability to attend appointments or participate in behavioral therapies
  • Parent and child live greater than 30 miles from the Duke Healthy Lifestyles clinic
  • Plan to move out of state in next 6 months
  • Child with medical condition as cause of obesity (e.g., hypothyroidism, Cushing's Syndrome, Prader-Willi syndrome (PWS), drug-induced obesity)

结局指标

主要结局

Change in Body Mass Index

时间窗: 3 and 6 months

Body mass index will be measured at 3- and 6-months post-enrollment.

次要结局

  • Change in Cardiovascular fitness(3- and 6-months)
  • Change in Health habits(3- and 6-month)
  • Change in Adherence to clinic appointments(3- and 6- months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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