跳至主要内容
临床试验/NCT00682188
NCT00682188已完成1 期

A School Nurse-Delivered Intervention for Overweight and At Risk Adolescents

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2008年9月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
84
试验地点
2
主要终点
BMI

研究概览

简要总结

Overweight in adolescents has nearly tripled in the past two decades and has serious physical and psychosocial consequences, both during adolescence and into adulthood. School nurses have tremendous potential to prevent and treat overweight in this population, as over 95% of adolescents have contact with the school health system each year and school nurses have the credibility and skills to provide guidance regarding weight, diet and physical activity. The goals of the proposed exploratory study are to adapt an innovative, theory-based school nurse-delivered counseling intervention model used effectively for smoking cessation for the treatment of adolescent overweight, and test its feasibility and potential efficacy in reducing BMI, improving diet, increasing physical activity and decreasing sedentary behavior. If the results of this exploratory study prove promising, the efficacy of the intervention will be evaluated in a large scale randomized controlled trial.

详细描述

Overweight in adolescents has nearly tripled in the past two decades and has serious physical and psychosocial consequences, both during adolescence and into adulthood. School nurses have tremendous potential to identify, prevent, and treat overweight in this population, as over 95% of children and adolescents have contact with the school health system each year and school nurses have the credibility and skills to provide guidance regarding weight, diet and physical activity. However, to our knowledge there have been no randomized controlled school-based trials that have utilized the school nurse to deliver weight-related intervention to adolescents. In a RCT conducted by the investigators, we found a school nurse-delivered smoking cessation intervention was successful in assisting adolescent smokers to quit, being both feasible to deliver in the school health setting and very well received by adolescents.

This two-year exploratory study will adapt this innovative, theory-based school nurse-delivered intervention model for the treatment of adolescent overweight, and test its feasibility and potential efficacy in reducing BMI, improving diet, increasing physical activity and decreasing sedentary behavior. The content of the intervention will be based on current clinical guidelines for the treatment of overweight in adolescents and Social Cognitive Theory (SCT), employing cognitive-behavioral techniques to facilitate changes in a set of very focused self-management behaviors: diet (at least 5 fruits vegetables a day; avoid soda and sugar sweetened drinks), physical activity (at least 1 hour on most days), and sedentary behavior (less than 2 hours of TV, video, and computer time a day). Four high schools in Massachusetts will be pair matched on demographics, school size, and percent low income and randomly assigned to one of two conditions: (1) Counseling Intervention (CI) consisting of six 30-minute individual student-centered counseling sessions delivered by school nurses over 2 months (weekly in month 1, biweekly in month 2); or (2) Information Intervention (II) attention-control comparison condition consisting of six individual sessions with the school nurse over 2 months (weekly in month 1, biweekly in month 2) to check status regarding weight and behavior changes and deliver a series of standardized pamphlets on weight and weight management. Adolescents (n=84) enrolled in grades 9 through 12 at-risk for overweight (body mass index (BMI) between the 85th and 94th percentile for age and gender) or overweight (BMI at or greater than the 95th percentile) will be recruited from the four schools. Assessments will be conducted at baseline and at 3-and 6-month follow-up. Should the results of this exploratory study prove promising the efficacy of the intervention will be evaluated in a large scale RCT. If found to be effective, such a school nurse-delivered intervention for adolescent overweight would have tremendous potential for wide-scale dissemination.

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
Single (Participant)

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • enrolled in grades 9 through 12
  • BMI equal or greater than 85th percentile
  • able to understand and participate in study protocol
  • able to provide informed assent (adolescent) and consent (parent)
  • student and at least one parent English speaking

排除标准

  • unable/unwilling to provide informed assent (adolescent)and consent (parent)
  • planning to move out of the area within the next 6 months
  • medical condition that precludes adherence to study dietary recommendations
  • diagnosis of a serious psychiatric illness within the past 5 years
  • genetic or endocrine causes of obesity
  • developmental delay that would prevent participation in intervention or measurements
  • prescribed medications associated with weight gain
  • morbidly obese, defined as 300 pounds oe greater

结局指标

主要结局

BMI

时间窗: 3- and 6-month post baseline

次要结局

  • Adherence to self-management behaviors (diet, physical activity, and sedentary behavior)(3- and 6-month post baseline)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lori Pbert

Professor of Medicine

University of Massachusetts, Worcester

研究点 (2)

Loading locations...

相似试验

进行中(未招募)
不适用
Estudio en fase II multicéntrico en adultos con leucemia mielógena aguda (LMA) en primera remisión completa (RC1) usando BuCy2 IV en un régimen con Bu una vez al día dirigido a reducir la ventana terapéutica previo al transplante de células madre hematopoyéticas.
EUCTR2009-016601-42-ESPIERRE FABRE MEDICAMENT28
招募中
2 期
A phase II trial for T-cell AT-cell acute lymphoblastic leukemiaPrecursor T-Cell Lymphoblastic Leukemia-Lymphoma
JPRN-jRCTs041210054Sato Atsushi259
进行中(未招募)
1 期
ong-term extension study of ligelizumab in food allergyMedDRA version: 20.0Level: PTClassification code: 10016946Term: Food allergy Class: 100000004870MedDRA version: 20.0Level: LLTClassification code: 10077084Term: Allergic reaction to food Class: 10021428Food allergy
CTIS2022-502366-25-00ovartis Pharma AG550
进行中(未招募)
不适用
A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid ArthritisMedDRA version: 7.1Level: LLTClassification code 10039073Rheumatoid Arthritis
EUCTR2005-000158-61-EEGlaxoSmithKline Research & Development Limited2,210
进行中(未招募)
不适用
A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid ArthritisMedDRA version: 7.1Level: LLTClassification code 10039073Rheumatoid Arthritis
EUCTR2005-000158-61-HUGlaxoSmithKline Research & Development Limited2,210