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临床试验/NCT01358448
NCT01358448已完成不适用

A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity

The University of Tennessee, Knoxville2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2011年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
Weight Status

研究概览

简要总结

In 2007 the Expert Committee published recommendations on the prevention and treatment of childhood obesity. These recommendations outlined four interventions intended for advancement based on the child's age, body mass index (BMI), and response to treatment. The initial stage, Prevention Plus, is to be implemented in the primary care setting and focuses on primary care providers monitoring growth monthly and delivering intervention messages that target dietary and leisure-time behaviors that most contribute to energy imbalance in children. Little research has evaluated the efficacy of these recommendations. Thus the primary goal of the proposed pilot study is to test the feasibility of the Prevention Plus stage for treating childhood overweight and obesity in a primary care setting. As the cost of interventions is a large barrier to the translation of evidence-based research into primary care settings, a second goal of the project is to evaluate program cost-effectiveness.

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
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •between 4 to 8 years of age at the start of the intervention
  • •overweight or obese (≥85th BMI-for-age percentile)
  • •have no medical conditions that effect growth, intake or physical activity (e.g., Prader Willi Syndrome, type 2 diabetes, etc.)
  • •not currently participating in a weight loss program and/or taking weight loss medication
  • •have a primary caretaker willing to participate in the research study, receive monthly newsletters and be randomized to one of the three conditions
  • •caretaker must be able to read, speak and understand English and the child speak English
  • •have transportation to their child's primary care provider office
  • •family does not plan to move out of the area before March 2012

排除标准

  • 未提供

研究组 & 干预措施

Newsletter

No Intervention

Growth Monitoring

Experimental

干预措施: growth monitoring (Behavioral)

Growth Monitoring plus Family-based Behavioral Counseling

Experimental

干预措施: Growth Monitoring plus Family-based Behavioral Counseling (Behavioral)

结局指标

主要结局

Weight Status

时间窗: Baseline and 6-month

BMI z-score

Dietary Intake

时间窗: baseline and 6-months

dietary intake (sweetened beverages, fruits and vegetables, energy, and percent energy from fat)

Leisure-time Behaviors

时间窗: Baseline and 6-months

leisure-time behaviors (moderate-intense physical activity and television viewing)

Caretaker Feeding Behaviors

时间窗: Baseline and 6-months

Caretaker feeding behaviors (authoritative, authoritarian, permissive, restrictive) assessed by questionnaires

次要结局

  • Cost Effectiveness(6-months)

研究者

发起方
The University of Tennessee, Knoxville
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hollie Raynor

Professor

The University of Tennessee, Knoxville

研究点 (2)

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