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临床试验/NCT02905422
NCT02905422已完成不适用

Healthy Eating, Activity, & Lifestyle Training Headquarters: II (H.E.A.L.T.H -II) Pilot Project

Pennington Biomedical Research Center2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年1月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Change from Baseline Weight at 6 Months and 12 Months
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The proposed study aims to combine evidenced based tools and guidance (H.E.A.L.T.H.: Healthy Eating Activity Lifestyle Training Headquarters) previously tested that has been developed specifically for use by Army Soldiers and a remote clinical intervention model that includes mobile tracking technology/devices for physical activity, weight and nutrition. This program is called the H.E.A.L.T.H. Intensive.

详细描述

The purpose of this investigation is to test the efficacy of a remote intervention to assist Soldiers in meeting standards for body fat and fitness. The intervention will include:

  1. An Internet/Smartphone program for weight management and weight gain prevention developed during previous DoD research.
  2. Integrated remote monitoring technology/devices, e.g. smart scales, activity tracking devices.
  3. Individualized weight management and exercise recommendations based on data collected from web/mobile app/devices to be delivered via web/mobile app/Smartphone; participants will not travel to a clinical facility for the intervention.

The objectives are:

  1. to further develop the H.E.A.L.T.H. intervention by merging components of the H.E.A.L.T.H. program, remote monitoring technology components, e.g. activity tracking devices, smart scales, and direct/individualized weight management and exercise feedback into a single and comprehensive intervention that targets weight and fat loss, improved fitness, improved sleep, and personal well-being for Soldiers and their family members.
  2. Compare body weight, body fat, and activity changes associated with participation in the H.E.A.L.T.H Intensive intervention for six months and a six-month website only phase/follow-up phase, in comparison to participation in a wait-list control group; and
  3. Evaluate blood biomarkers associated with changes in body weight. Evaluate changes in gut bacteria associated with body weight.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

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

入选标准

  • •Male and Female Soldiers who are members of the Louisiana National Guard
  • •Direct family member of the LANG member who is enrolled in the study and will participate with the Soldier
  • •≥18 years old
  • •For Soldiers: BMI ≥ 25, AND who exceeds Screening Table Weight AND maximum allowed body fat as outlined by AR600-9 Army regulations For Family Member: BMI ≥ 25
  • •Has no known deployments (to the best of their knowledge) for one year upon beginning the study

排除标准

  • •Soldiers and family members younger than 18 years of age
  • •Soldiers and family members who are pregnant
  • •Soldiers and family members who cannot read
  • •Soldiers and family members who do not have daily access to wifi
  • •Soldiers and family members who do not have access to a smartphone

结局指标

主要结局

Change from Baseline Weight at 6 Months and 12 Months

时间窗: Baseline, 6 Months, 12 Months

Standard Weight Scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tiffany Stewart

Associate Professor, Director, Behavior Technology Laboratory

Pennington Biomedical Research Center

研究点 (2)

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