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临床试验/NCT01989065
NCT01989065已完成不适用

Healthy Lifestyles Program for You (HLP4U): Augmenting Childhood Obesity Treatment Through Provider-to-parent Text Messaging.

Duke University2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2014年9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
101
试验地点
2
主要终点
Food and Activity Frequency Survey Score

研究概览

简要总结

Outpatient childhood obesity treatment has limited efficacy. This study aims to improve the health habits of parents of obese 5-12 year old children enrolled in the Duke Healthy Lifestyles Program by delivering educational and supportive text messages to the parent's mobile device.

详细描述

Protocol Title Healthy Lifestyles Program for You (HLP4U): Augmenting childhood obesity treatment through provider-to-parent text messaging.

Significance One in three children in the US are overweight or obese, a condition known to increase the risk of adult obesity and chronic disease. Behavioral treatment of pediatric and adolescent obesity is strongly recommended, and in research settings treatment has shown efficacy in reduction of child body mass index (BMI) and improved long-term health outcomes. However, clinical treatment models must operate within the constraints of the outpatient practice, and are limited in their ability to deliver the same intensity of intervention or outreach. Not surprisingly, clinic-based treatment of child obesity is less effective than in research settings.

"Motivational Interviewing" (MI) has emerged as a promising clinical method for improving health outcomes in childhood obesity treatment. "Motivation" is defined as an individual's expressed intention to change, and is divided into three measurable elements: importance, confidence, and readiness. The theoretical framework of MI focuses on the interpersonal aspects of behavioral change between patient and provider. MI emphasizes provider empathy, support for patient autonomy, exploring ambivalence and reinforcing change talk. Several studies have demonstrated that childhood obesity treatments that use MI effectively are more likely to achieve improved child outcomes than those who do not. These outcomes include decreased BMI,6 increased physical activity, and improvements in parental confidence.

The Healthy Lifestyles (HL) program is an AAP Stage 2-4 childhood obesity program3 located in Durham, NC. Children with BMI above the 95th percentile are referred to HL by their primary provider. The Healthy Lifestyles clinical protocol has been described elsewhere. In short, children aged 22 years and under with BMI ≥ 95th percentile are referred by their primary physician to the multidisciplinary HL 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. Despite the comprehensive model, and despite consistent delivery of behavior change counseling using motivational interviewing, the Healthy Lifestyles model does not lead to significant decreases in body mass index. Less than 25% of patients who initially enroll complete treatment. These outcomes are similar to other comprehensive child obesity programs nationally. There is a clear need for effective treatment options.

A rapidly evolving field of study is investigating the use of healthcare provider-to-text messages to augment patient behavior change. Text messaging is attractive, in part, because text penetrance to mixed ethnic, racial, and socioeconomic populations is high, and 80-81% of sent messages are read with a mean response time of 6 minutes. Text messages as simple reminders can lead to improvements in patient compliance with medications and immunizations. Text messages targeting behaviors can decrease TV viewing time among young children when texts are delivered to the parent. Text messages can also improve self-efficacy when they offer encouragement, recognize the difficulty of change, and congratulate the patient on change. To date, no studies have investigated the use of provider-to-parent text messages utilizing MI theory to increase the effectiveness of childhood obesity treatment.

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 12 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 5-12 years
  • Child with age- and gender-specific BMI ≥ 95th percentile
  • Parent has mobile phone with texting plan

排除标准

  • Inability to read and write in English
  • Parent with severe medical or mental health condition limiting ability to attend appointments
  • Plan to move out of state in next 3 months

结局指标

主要结局

Food and Activity Frequency Survey Score

时间窗: 3 month post-enrollment

Validated lifestyle behavior survey, addresses common behaviors such as beverages, fast food, television time. 20 questions on 4-point Likert.

次要结局

  • General Self-Efficacy Survey Score(3 month post-enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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