PREDICT: Nutrigenetic Profile of Patients With Weight Loss Success (PREDICT)

September 20, 2016 updated by: Amir Zarrinpar, San Diego Veterans Healthcare System

PREDICT: Nutrigenetic Profile of Patients With Weight Loss Success in MOVE! and TeleMOVE! Programs

This observational study will investigate the potential clinical utility of the Pathway Fit® test by investigating whether patients who successfully lose weight (defined as losing at least 5% of body weight 8 weeks after initiation) in the MOVE! or TeleMOVE! Weight Management programs have a distinct nutrigenetic profile over those that were unable to lose a significant amount of weight. We will use electronic records to identify all individuals who have successfully completed the MOVE! program (i.e. attended the full 8 week course) or TeleMOVE! program. In addition we will find age- and gender- matched individuals who attended and completed the MOVE! or TeleMOVE! programs but did not lose weight. After completion of the MOVE! or TeleMOVE! programs Veterans will submit a saliva sample for the Pathway Fit® test. Also, blood will be collected for storage for further studies on metabolomics. The start and end weight of all participants will be recorded. The nutrigenic profiles of those with successful weight loss will be compared to those less successful to determine if this cohort has a particular genetic profile.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The overall prevalence of metabolic syndrome in the general US population is estimated to be 22-34.5% with greater prevalence in certain populations (e.g. Mexican and African Americans, women). These numbers have been consistent with the rise of prevalence of obesity in the US population to 34.9%, which has remained stable over the last 10 years. Veterans are particularly predisposed to metabolic syndrome since the prevalence of obesity is much higher among their ranks. Since the annual medical cost of those who are obese or have metabolic syndrome is $1429 higher than those at a healthy weight, the impact on the cost of healthcare for Veterans can be potentially tremendous. This is mainly since obesity is strongly associated with many chronic diseases, including type 2 diabetes, cardiovascular disease, some types of cancer (endometrial, postmenopausal breast, kidney, and colon), musculoskeletal disorders, sleep apnea, and gallbladder disease.

In order to combat the obesity epidemic in Veterans, the U.S. Department of Veterans Affairs created the MOVE! Weight Management Program (MOVE!) in 2006. MOVE! is an evidence-based weight-management program designed for patients followed in primary care clinics and who have a BMI of ≥30kg/m2 or with a BMI of ≥25kg/m2 with 1 or more obesity-related conditions (e.g. diabetes, hypertension, dyslipidemia). The efficacy of the program is measured by the % of patients who losing at least 5% of body weight at 8 weeks and 6 months after first session. In addition, TeleMOVE! is a program recently initiated within the VA system to help individuals who cannot make it to the VA MOVE! program due to their work schedule or distance from VA clinic.

This observational study will investigate the potential clinical utility of the Pathway Fit® test by investigating whether patients who successfully lose weight (defined as losing at least 5% of body weight 8 weeks after initiation) in the MOVE! or TeleMOVE! programs have a distinct nutrigenetic profile over those that were unable to lose a significant amount of weight. We will use electronic records to identify all individuals who have successfully completed the MOVE! program (i.e. attended the full 8 week course) or TeleMOVE! program. In addition we will find age- and gender- matched individuals who attended and completed the MOVE! Or TeleMOVE! programs but did not lose weight. After completion of the MOVE! Or TeleMOVE! programs Veterans will submit a saliva sample for the Pathway Fit® test. The start and end weight of all participants will be recorded. The nutrigenic profiles of those with successful weight loss will be compared to those less successful to determine if this cohort has a particular genetic profile. Also, blood will be collected for storage for further studies on metabolomics.

To encourage participation, participants will be reimbursed for their participation in the study and the Pathway Fit® test results will be provided to all. Comparisons on all pertinent measures will be made between those achieving at least 5% weight loss and those that did not.

Upon completion of the study, the clinical utility of the Pathway Fit® test can be further investigated to determine if the successful nutrigenic profile can predict clinical outcomes of the participants in the MOVE! program or other lifestyle management programs.

Study Type

Observational

Enrollment (Anticipated)

200

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

US Veterans who have completed the MOVE! or TeleMOVE! program between 2011-2016

Description

Inclusion Criteria:

  • Completion of the MOVE! Program between 2006-2015 with attendance in at least 75% of classes for group A cohort.
  • Completion of the MOVE! Program from 2012-2015 with participation in >75% of activities for group B cohort.
  • The patient understands and has signed the study informed consent form.
  • Veteran enrolled in the VA Healthcare System and followed by a VA primary care provider.

Exclusion Criteria:

  • History of, or current diagnosed DSM-IV-TR eating disorder (i.e., anorexia nervosa or bulimia nervosa) or any current compensatory behaviors (e.g., vomiting, laxative use, excessive exercise).
  • Individuals with prescription medication usage, or other medical/psychological conditions that could interfere with the physician's ability to assess the effect of the test results on weight loss.
  • History of bipolar disorder, or organic brain syndromes; report hospitalization for any psychiatric disorder within the last 12 months.
  • Are currently participating in a weight loss program and/or taking weight loss medication.
  • Lost > 5% of body weight during the past 6 months or history of bariatric surgery.
  • Failure to complete screening appointments.
  • Health problems which may influence the ability to walk for physical activity or be associated with unintentional weight change, including cancer treatment within the past 5 years or tuberculosis.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Successful weight loss
Patients who have lost =>5% of their weight after completing MOVE! or TeleMOVE!
Genetic: Pathway Genomics FIT test
Unsuccessful weight loss
Patients who have lost <5% of their weight after completing MOVE! or TeleMOVE!
Genetic: Pathway Genomics FIT test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic SNP results
Time Frame: 3 months after start of MOVE! or TeleMOVE!
Checking to see if our case control have different genotypes
3 months after start of MOVE! or TeleMOVE!

Collaborators and Investigators

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

Sponsor

San Diego Veterans Healthcare System

Collaborators

Pathway Genomics Corp

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

September 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 22, 2016

Study Record Updates

Last Update Posted (Estimate)

September 22, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H150148

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.

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