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临床试验/NCT04959318
NCT04959318已完成不适用

Precision Nutrition Impact on Health-Related Behavior Change in Active Duty Service Members

Madigan Army Medical Center2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2019年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
138
试验地点
2
主要终点
Weight loss

研究概览

简要总结

A prospective, randomized, controlled trial enrolling up to 150 service members (SMs) from two sites; Joint Base Lewis McChord (JBLM) in the Northwest and Joint Base San Antonio (JBSA)-Lackland in the Southwest. A baseline genomic profile (70 genes/80 single nucleotide polymorphisms [SNPs]) augmented by common serum biomarkers specific to diet-related chronic disease (metabolic syndrome, cardiovascular disease [CVD], vitamin D deficiency) risk will be created. Subjects will be randomized to either personalized nutrition counseling or standard nutrition education for 6 weeks. This interval matches Service-run healthy weight initiatives such as the Army's current Fit for Performance Program. To promote self-care and engagement, a digital app will be utilized for 2 weeks for real-time health data capture with continuous feedback and will be validated with in-person RD interviews. Physical activity and injury data, sun exposure, and family history will help elucidate unique individual responses. Participant follow-up at 12 weeks will evaluate changes in anthropometrics and metabolic, cardiovascular, and vitamin D biomarkers.

详细描述

Precision nutrition leverages the specificity of molecular and phenotypic differences in personalizing diet and lifestyle interventions. Specific Aims: 1) Examine the effectiveness of gene-based nutrition counseling on health-related behavior change in service members as measured by body weight, body mass index (BMI), blood glucose, lipids, 25-hydroxyvitamin (OH) D, %body fat (BF), waist circumference, and blood pressure; 2) Evaluate the feasibility of a digital application to accurately capture diet, activity, and sleep behaviors; and 3) Describe military-unique characteristics in demographics, diet, and lifestyle for northwest Army and southwest Air Force cohorts.

A baseline genomic profile will be created from 70 diet-responsive genes and 80 variants following amplicon sequencing on an Illumina MiSeq platform and will be informed by serum biomarkers specific to diet-related chronic disease risk (i.e. metabolic syndrome, vitamin D deficiency) for each subject. Risk variants were selected if minor allele frequency > 5% and at least two published papers verified the link to the phenotype of interest. Treatment group receives gene-based nutrition counseling for six weekly sessions; Controls receive evidence-based nutrition pamphlets, all content directed at preventing metabolic syndrome. A digital app provides real-time health data capture with continuous feedback and is verified by in-person dietitian interviews. Both groups will also use study resources independently for six weeks, returning for final body composition and serum biomarkers after the twelve-week intervention. The control group receives the genomic profile with dietary recommendations upon study completion. Data analysis will examine between-group and by-cohort differences on primary anthropometric and biomarker outcomes.

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
Single (Outcomes Assessor)

盲法说明

The statistician is external to the research team and has not been involved throughout the trial period. She will receive data upon completion of the trial and perform the outcomes assessment.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Active duty Army or Air Force
  • Age 18-45
  • Able to read and comprehend English
  • Assigned to JBLM or JBSA-Lackland,
  • Remaining on station for 5 months
  • Consider self generally healthy
  • History of or currently out of compliance with military fitness standards
  • Willing to submit 2 blood samples including one for gene testing
  • Willing to undergo 1 DEXA scan (JBLM only)
  • Willing to participate in 6 weekly nutrition counseling sessions if assigned to treatment group

排除标准

  • Currently diagnosed with an eating disorder
  • Current physical training profile (ie limitation)
  • Pending deployment in next 5 months
  • Pending retirement in next 5 months
  • Pending permanent change of duty station in the next 5 months
  • Currently has a pacemaker (contraindicated for bioelectrical impedance analysis)

结局指标

主要结局

Weight loss

时间窗: 12-14 weeks

Pounds lost between measurements

次要结局

  • Diastolic blood pressure(12-14 weeks)
  • Waist circumference(12-14 weeks)
  • Serum Cholesterol(12-14 weeks)
  • Systolic blood pressure(12-14 weeks)
  • Serum glucose(12-14 weeks)
  • Serum triglyceride(12 -14 weeks)
  • Body fat(12-14 weeks)

研究者

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

Mary S McCarthy

Nurse Scientist

Madigan Army Medical Center

研究点 (2)

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