Precision Nutrition Impact on Health-Related Behavior Change

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: Professional nutrition counseling
* Other: No professional nutrition counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects were enrolled, submitted fasting blood sample, and returned for initial measurements when lab results were available. At this visit, randomization based on a random number generator and concealed allocation with sequentially numbered opaque envelopes took place. This allowed the first treatment/professional counseling session to be held the same day depending on group assignment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group or counseling group<br>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<br>* 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.<br>* Other names: Gene-based dietary counseling;|
| Active Comparator: Control group or comparison group<br>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<br>* 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.<br>* Other names: Pamphlets;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nutrition, military, nutrigenomics