PREDICT: Nutrigenetic Profile of Patients With Weight Loss Success

NCT02910869 | Unknown DMC

• 1 other identifier: H150148
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Genetic SNP results

  Checking to see if our case control have different genotypes

  3 months after start of MOVE! or TeleMOVE!

Study Arms (2)

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

Interventions

Pathway Genomics FIT test GENETIC

Successful weight loss; Unsuccessful weight loss

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Diego Veterans Healthcare System: lead
• Pathway Genomics Corp: collaborator

Related Publications (6)

• Ford ES, Giles WH, Dietz WH. Prevalence of the metabolic syndrome among US adults: findings from the third National Health and Nutrition Examination Survey. JAMA. 2002 Jan 16;287(3):356-9. doi: 10.1001/jama.287.3.356.

  PMID: 11790215 BACKGROUND

• Ford ES, Li C, Sattar N. Metabolic syndrome and incident diabetes: current state of the evidence. Diabetes Care. 2008 Sep;31(9):1898-904. doi: 10.2337/dc08-0423. Epub 2008 Jun 30.

  PMID: 18591398 BACKGROUND

• Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.

  PMID: 24570244 BACKGROUND

• Koepsell TD, Littman AJ, Forsberg CW. Obesity, overweight, and their life course trajectories in veterans and non-veterans. Obesity (Silver Spring). 2012 Feb;20(2):434-9. doi: 10.1038/oby.2011.2. Epub 2011 Feb 3.

  PMID: 21293452 BACKGROUND

• Kinsinger LS, Jones KR, Kahwati L, Harvey R, Burdick M, Zele V, Yevich SJ. Design and dissemination of the MOVE! Weight-Management Program for Veterans. Prev Chronic Dis. 2009 Jul;6(3):A98. Epub 2009 Jun 15.

  PMID: 19527600 BACKGROUND

• Kahwati LC, Lance TX, Jones KR, Kinsinger LS. RE-AIM evaluation of the Veterans Health Administration's MOVE! Weight Management Program. Transl Behav Med. 2011 Dec;1(4):551-60. doi: 10.1007/s13142-011-0077-4.

  PMID: 24073079 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva Blood

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 16, 2016
• First Posted: September 22, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Last Updated: September 22, 2016

Record last verified: 2016-09