NCT01859403

Brief Summary

This study aims to determine if providing genomic information to veterans can help them lose weight compared to usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
7 years until next milestone

Results Posted

Study results publicly available

March 1, 2021

Completed
Last Updated

April 13, 2021

Status Verified

March 1, 2021

Enrollment Period

1.1 years

First QC Date

May 17, 2013

Results QC Date

February 8, 2021

Last Update Submit

March 19, 2021

Conditions

Obesity

Keywords

veteranobesitypersonalized genomics

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Weight Loss of 5% or More at 8 Weeks

    Our primary hypotheses are that more obese veterans in the MOVE! program will lose greater or equal to 5% of their weight if they receive personalized genomic information and a genomically-derived diet built around packaged meals when compared to veterans in the same program that receive usual care during MOVE! and packaged meals after 8 weeks.

    8 weeks

Secondary Outcomes (1)

  • Number of Participants With Weight Loss of 5% or More at 24 Weeks

    24 weeks

Study Arms (2)

Usual Care

PLACEBO COMPARATOR

Usual care for veterans as part of the MOVE! program

Genetic: Usual Care

Personalized Genomics

ACTIVE COMPARATOR

Personalized genomics information from the FIT Test, Pathway Genomics

Genetic: Personalized Genomics

Interventions

Personalized GenomicsGENETIC

A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise

Also known as: FIT test from Pathway Genomics, Inc.
Personalized Genomics
Usual CareGENETIC

Patients receive the same dietary recommendation regardless of their genetic information

Also known as: Standard dietary recommendations
Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans able to receive care at the VASDHS and planning to start the MOVE! program.
  • Veterans able to understand and consent to the study.
  • BMI equal to or greater than 30 kg/m2.

You may not qualify if:

  • Veterans unable to receive care at the VASDHS.
  • Veterans unable to understand the consent process at the discretion of the PI.
  • Active substance abuse or substance dependence disorder
  • Cognitive disorder, psychiatric hospitalization in past 6-months, or presence of suicidal ideation identified on self-report instruments
  • Bradycardia, rapid heart rate or other arrhythmia or active ischemia by EKG.
  • Uncontrolled thyroid disease as measured by a TSH above or below the normal range.
  • Body mass index \< 30 kg/m2.
  • Chronic kidney disease stage III or higher by National Kidney Foundation criteria (GFR = 30-59 ml/min).
  • New York Heart Association's functional classification of congestive heart failure above Class I (not limited with normal physical activity by symptoms; Class II occurs when ordinary physical activity results in fatigue, dyspnea, or other symptoms).
  • Sodium or potassium outside the normal range.
  • Edema requiring the use of daily diuresis with furosemide, bumex or other diuretic (does not include hydrochlorthiazide).
  • The use of high dose oral corticosteroids (above replacement doses).
  • Veterans deficient in 25-OH vitamin D (\<20 units/dl).
  • Veterans with fasting LDL \> 190 mg/dl.
  • Veterans with fasting triglyceride levels \> 1000 mg/dl.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Related Publications (1)

  • Frankwich KA, Egnatios J, Kenyon ML, Rutledge TR, Liao PS, Gupta S, Herbst KL, Zarrinpar A. Differences in Weight Loss Between Persons on Standard Balanced vs Nutrigenetic Diets in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2015 Sep;13(9):1625-1632.e1. doi: 10.1016/j.cgh.2015.02.044. Epub 2015 Mar 10.

    PMID: 25769412DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Amir Zarrinpar, MD, PhD, Assistant Professor of Gastroenterology
Organization
VA San Diego Health Sciences
azarrinpar@health.ucsd.edu
858-246-1665

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 17, 2013

First Posted

May 21, 2013

Study Start

November 1, 2012

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

April 13, 2021

Results First Posted

March 1, 2021

Record last verified: 2021-03

Locations

US(1)