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临床试验/NCT02679937
NCT02679937已完成不适用

Prevention of Obesity in Military Communities - Fit4Duty: Phase 2

Henry M. Jackson Foundation for the Advancement of Military Medicine4 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2014年6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
119
试验地点
4
主要终点
Participant weight (lbs)

研究概览

简要总结

This randomized controlled trial assesses the efficacy of a 6-week, dissonance-based, weight-gain prevention program (Fit4Duty) designed to reduce unhealthy weight gain among military service members at-risk for obesity. The Fit4Duty program is an adaptation for the military of an existing civilian obesity prevention program, Project Health, which reduced obesity onset by 50% in healthy civilian young adults. Fit4Duty is compared to a nutrition education control condition and is hypothesized to reduce excess weight gain beyond the control comparison program during the 2 year period following study participation.

详细描述

Obesity is prevalent in military personnel and raises concerns related to health, readiness, and national defense. Adverse health consequences of obesity place military personnel at risk for serious medical problems while in the service and upon discharge/retirement. Additionally, failure to "make weight" may negatively impact one's military career and can lead to discharge from the service. Early identification of personnel at risk and implementation of prevention strategies are critical to addressing the problem of overweight in the military and are essential to maintaining a fit fighting force. The goal of this study is to test the effectiveness of a dissonance-based, weight-gain prevention program (Fit4Duty) to prevent excess weight gain among service members at risk for obesity due to a personal and/or family history of overweight. The Fit4Duty program is an adaptation for the military of an existing civilian obesity prevention program, Project Health. The program utilizes dissonance based, participant-driven group counseling to address the excess consumption of unhealthy foods and sedentary behavior. Active duty service members will be randomized to the Fit4Duty weight gain prevention program or a Nutrition Education comparison condition. Participants will complete height, weight, and body composition measurements, and self-report instruments at baseline, immediately following the prevention program (6-weeks), and one and two year follow-ups. It is hypothesized that Project Fit4Duty will result in significantly greater reduction in risk for increases in BMI percentile and percent fat mass, and risk for onset of overweight and obesity during the 2-year follow-up relative to a nutrition education control program. If successful, Project Fit4Duty would offer an economical approach for widespread obesity prevention in the U.S. Military.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Active Duty Service Member
  • 18.5 kg/m2 < BMI ≤ 32kg/m2
  • At risk for excess weight gain due to personal and/or family history of overweight
  • English speaking
  • Ability to complete study procedures

排除标准

  • Presence of a major, chronic medical illness
  • Illness and/or treatment likely to affect appetite or body weight
  • Planned deployment/ training during the intervention period (upcoming 2 months)
  • Documented or self-reported current pregnancy, current breast-feeding, or recently pregnant women (within 1 year of delivery). Because pregnancy is a state in which weight gain is expected and appropriate, pregnant individuals would not be suitable for this study
  • Evidence or signs of suicidal ideation as determined by the research team

研究组 & 干预措施

Fit4Duty

Experimental

6-week weight gain prevention group

干预措施: Fit4Duty (Behavioral)

Nutrition Education

Active Comparator

Two, 50 minute educational videos.

干预措施: Nutrition Education (Other)

结局指标

主要结局

Participant weight (lbs)

时间窗: Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years

Participants will be weighed using professional grade equipment and trained personnel

次要结局

  • Body Composition: body fat %(Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years)
  • Abdominal waist and hip circumference(Baseline, Change from basline at post-treatment (6 weeks), 1 year and 2 years)

研究者

发起方
Henry M. Jackson Foundation for the Advancement of Military Medicine
申办方类型
Other
责任方
Sponsor

研究点 (4)

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