Precision Nutrition Impact on Health-Related Behavior Change

February 7, 2025 updated by: Mary S McCarthy, Madigan Army Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Currently diagnosed with an eating disorder
  • Pregnant
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group or counseling group
The treatment group will receive a counseling intervention addressing metabolic syndrome (comprised of abdominal adiposity, high blood pressure, high cholesterol, elevated fasting glucose, and elevated triglyceride level) and low vitamin D. This group will undergo baseline body composition measurements, phlebotomy, and an introduction to the digital app for recording diet and activity.
Other: Professional nutrition counseling
Published multi-cohort genome-wide association studies provided genes and genetic variants that are credibly associated with aspects of metabolic syndrome (MetS), CVD, overweight/obesity, and vitamin D metabolism. Registered dietitian (RD) counseling will review potentially harmful and protective variants for risk of MetS with subjects and make evidence-based recommendations to improve diet quality and achieve weight loss goals. Each of the 6 weekly sessions covered a specific component of MetS. Counseling will take place once a week either in-person or via phone/virtual platform based on preference and availability of the subject. Counselors will review digital app data entries for food intake prior to this interaction for the first 2 weeks.
Other Names:
  • Gene-based dietary counseling
Active Comparator: Control group or comparison group
Subjects randomized to the control group will undergo baseline body composition measurements, phlebotomy, and an introduction to the app for recording diet and activity. They will receive a packet of evidence-based pamphlets addressing Service-specific approaches to healthy eating and physical activity (e.g. Performance Triad). There will be no formal recurring interaction with an RD for those randomized to this control group.
Other: No professional nutrition counseling
Participants receive pamphlets with evidence-based general health, healthy nutrition, exercise and sleep content. They receive information on genetic variants related to MetS at end of study period.
Other Names:
  • Pamphlets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 12-14 weeks
Pounds lost between measurements
12-14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body fat
Time Frame: 12-14 weeks
Percent change in body fat over time
12-14 weeks
Waist circumference
Time Frame: 12-14 weeks
Change in waist circumference measured in inches to reduce risk for MetS over time
12-14 weeks
Serum Cholesterol
Time Frame: 12-14 weeks
Blood level of serum cholesterol to reduce risk for MetS over time
12-14 weeks
Systolic blood pressure
Time Frame: 12-14 weeks
Change in systolic blood pressure to reduce risk for MetS over time
12-14 weeks
Diastolic blood pressure
Time Frame: 12-14 weeks
Change in diastolic blood pressure to reduce risk for MetS over time
12-14 weeks
Serum glucose
Time Frame: 12-14 weeks
Change in blood glucose level to reduce risk for MetS over time
12-14 weeks
Serum triglyceride
Time Frame: 12 -14 weeks
Change in blood triglyceride level to reduce risk for MetS over time
12 -14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Madigan Army Medical Center

Collaborators

TriService Nursing Research Program

Investigators

  • Principal Investigator: Mary S McCarthy, PhD, Madigan AMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2019

Primary Completion (Actual)

July 9, 2021

Study Completion (Actual)

July 9, 2021

Study Registration Dates

First Submitted

July 1, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 13, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 219081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe