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DiabetesEarly Phase 1LINKING GAINSNCT07833384

The Effect of Providing Genetic Risk Information on Lifestyle Behaviors in African Americans

A Early Phase 1 study testing Color Genomics Genetic Testing Panels in people with Diabetes and Hypercholesterolaemia, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cardiovascular disease (CVD) is a major and persistent health disparity for African Americans. Linking GAINS is a randomized pilot and feasibility study designed to evaluate whether receiving genetic risk information early in a community-based CVD risk reduction intervention improves engagement and health behavior… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes, Hypercholesterolaemia, Hypertension
What is being tested?
Color Genomics Genetic Testing Panels
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
22 Sep 2025to 26 Mar 2026
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older.
  • Self-identification as African American.
  • Willing to complete genetic testing using a saliva DNA collection kit.
  • Willing to participate in a CVD risk reduction behavioral intervention lasting approximately 16 weeks.
  • Able and willing to provide informed consent.

Who cannot join

  • Cannot safely engage in physical activity.
  • Has current knowledge of genetic contributions to CVD that would compromise the study comparison.
  • Pregnant at the time of eligibility assessment, because the study observes body weight and physiologic outcomes without pregnancy as a confounder.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Cardiovascular disease (CVD) is a major and persistent health disparity for African Americans. Linking GAINS is a randomized pilot and feasibility study designed to evaluate whether receiving genetic risk information early in a community-based CVD risk reduction intervention improves engagement and health behavior change. Sixty African American adults from the Baton Rouge metropolitan area will be recruited and randomized to a Genetically Unblinded (GU) group or a Genetically Blinded (GB) group. All participants will complete a 14-session behavioral intervention delivered over approximately 16 weeks, including culturally responsive education, nutrition and cooking sessions, physical activity training, group support, and community-based health resources. The GU group will receive genetic results and genetic counseling early in the intervention, while the GB group will receive genetic results and counseling after the behavioral intervention and end-of-study assessment. The primary endpoint is intervention engagement measured by attendance. Secondary outcomes include physical activity, dietary intake, body mass index, blood pressure, genomic orientation/knowledge, and perceived racism. Exploratory/moderator analyses will examine whether social determinants of health, including income, food insecurity, health literacy, occupational prestige, and experiences of racism, influence intervention engagement and behavior change.

Being tested
Color Genomics Genetic Testing Panels
Medical subject headings
Diabetes Mellitus, Hypercholesterolemia, Hypertension, Obesity, Overweight, Heart Failure, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Color Genomics Genetic Testing PanelsGenetic

    Participants gave a saliva sample to Color Genomics for an Ancestry, Hereditary Cancer, CVD, and Pharmacogenomics testing panel. Participants were able to get visuals of their results using their website and also discuss findings via zoom or phone call.

Study groups in NCT07833384
Study groupRoleWhat they receive
Genetically UnblindedActive comparatorGenetically unblinded participants received their genetic test results from Color Genomics: Cancer, CVD, and Pharmacogenomics panels before starting the health behavior intervention. In addition, they received a 1:1 genetic counseling session prior to the health behavior intervention completion.
Receives: Genetic: Color Genomics Genetic Testing Panels
Genetically BlindedExperimentalGenetically blinded participants received their genetic test results from Color Genomics: Cancer, CVD, and Pharmacogenomics panels. In addition, they received a 1:1 genetic counseling session after the health behavior intervention was completed.
Receives: Genetic: Color Genomics Genetic Testing Panels

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total number of participants that completed health behavior interventions.

    Measured by total health behavior sessions attended between groups.

    Measured: 14-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2026
  2. Study start22 Sep 2025
  3. Primary completion26 Mar 2026
  4. Study completion26 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07833384
Sponsor's protocol ID
PBRC 2024-043
Other IDs
P50MD017338
Acronym
LINKING GAINS
Status last verified
Sep 2026
First submitted
16 Sep 2026
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) underlying the primary and secondary analyses reported in publications arising from the Linking GAINS study will be made available. Shared data may include participant demographic characteristics, intervention assignment, attendance and retention measures, genomic knowledge assessments, behavioral outcomes, clinical measures (e.g., blood pressure, body mass index), and de-identified genomic result classifications (e.g., positive/negative clinical findings). Personally identifiable information, dates, direct identifiers, genetic sequence data, and other information that could reasonably identify participants will not be shared.

Publications

  • Marteau TM, Lerman C. Genetic risk and behavioural change. BMJ. 2001 Apr 28;322(7293):1056-9. doi: 10.1136/bmj.322.7293.1056. No abstract available.

    PubMed 11325776

  • Horne J, Madill J, Gilliland J. Incorporating the 'Theory of Planned Behavior' into personalized healthcare behavior change research: a call to action. Per Med. 2017 Nov;14(6):521-529. doi: 10.2217/pme-2017-0038. Epub 2017 Nov 24.

    PubMed 29749859

  • Horrow C, Pacyna JE, Lee MK, Sharp RR. Measuring Attitudes About Genomic Medicine: Validation of the Genomic Orientation Scale (GO Scale). Value Health. 2021 Jul;24(7):1030-1037. doi: 10.1016/j.jval.2021.02.001. Epub 2021 Apr 2.

    PubMed 34243827

  • McNeilly MD, Anderson NB, Armstead CA, Clark R, Corbett M, Robinson EL, Pieper CF, Lepisto EM. The perceived racism scale: a multidimensional assessment of the experience of white racism among African Americans. Ethn Dis. 1996 Winter-Spring;6(1-2):154-66.

    PubMed 8882844

  • Caldwell J, Jackson FLC. Evolutionary perspectives on African North American genetic diversity: Origins and prospects for future investigations. Evol Anthropol. 2021 Jul;30(4):242-252. doi: 10.1002/evan.21910. Epub 2021 Aug 13.

    PubMed 34388300

  • Sheppard VB, Sutton AL, Hurtado-De-Mendoza A, Tariq F, Perera RA, Quillin J, Jeudy M, Gomez-Trillos S, Schwartz MD. Addressing disparities in the uptake of genetic counseling and testing in African American women; rationale, design and methods. Contemp Clin Trials. 2023 Jul;130:107210. doi: 10.1016/j.cct.2023.107210. Epub 2023 May 2.

    PubMed 37142159

  • Lima SM, Nazareth M, Schmitt KM, Reyes A, Fleck E, Schwartz GK, Terry MB, Hillyer GC. Interest in genetic testing and risk-reducing behavioral changes: results from a community health assessment in New York City. J Community Genet. 2022 Dec;13(6):605-617. doi: 10.1007/s12687-022-00610-2. Epub 2022 Oct 13.

    PubMed 36227532

  • Chirinos DA, Vargas E, Kamsickas L, Carnethon M. The role of behavioral science in addressing cardiovascular health disparities: A narrative review of efforts, challenges, and future directions. Health Psychol. 2022 Oct;41(10):740-754. doi: 10.1037/hea0001191. Epub 2022 Jul 18.

    PubMed 35849358

  • Wyatt SB, Williams DR, Calvin R, Henderson FC, Walker ER, Winters K. Racism and cardiovascular disease in African Americans. Am J Med Sci. 2003 Jun;325(6):315-31. doi: 10.1097/00000441-200306000-00003.

    PubMed 12811228

  • Keaton JM, Cooke Bailey JN, Palmer ND, Freedman BI, Langefeld CD, Ng MC, Bowden DW. A comparison of type 2 diabetes risk allele load between African Americans and European Americans. Hum Genet. 2014 Dec;133(12):1487-95. doi: 10.1007/s00439-014-1486-5. Epub 2014 Oct 2.

    PubMed 25273842

  • Thornton RL, Glover CM, Cene CW, Glik DC, Henderson JA, Williams DR. Evaluating Strategies For Reducing Health Disparities By Addressing The Social Determinants Of Health. Health Aff (Millwood). 2016 Aug 1;35(8):1416-23. doi: 10.1377/hlthaff.2015.1357.

    PubMed 27503966

  • Turner-McGrievy GM, Wilcox S, Frongillo EA, Murphy EA, Hutto B, Wilson M, Davey M, Bernhart JA, Okpara N, Bailey S, Hu E. Effect of a Plant-Based vs Omnivorous Soul Food Diet on Weight and Lipid Levels Among African American Adults: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2250626. doi: 10.1001/jamanetworkopen.2022.50626.

    PubMed 36633848

  • Newton RL Jr, Carter LA, Johnson W, Zhang D, Larrivee S, Kennedy BM, Harris M, Hsia DS. A Church-Based Weight Loss Intervention in African American Adults using Text Messages (LEAN Study): Cluster Randomized Controlled Trial. J Med Internet Res. 2018 Aug 24;20(8):e256. doi: 10.2196/jmir.9816.

    PubMed 30143478

  • Albert MA, Carnethon MR, Watson KE. Disparities in Cardiovascular Medicine. Circulation. 2021 Jun 15;143(24):2319-2320. doi: 10.1161/CIRCULATIONAHA.121.055565. Epub 2021 Jun 14. No abstract available.

    PubMed 34125568

  • Zilbermint M, Hannah-Shmouni F, Stratakis CA. Genetics of Hypertension in African Americans and Others of African Descent. Int J Mol Sci. 2019 Mar 2;20(5):1081. doi: 10.3390/ijms20051081.

    PubMed 30832344

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Color Genomics Genetic Testing Panels in people with Diabetes and Hypercholesterolaemia, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total number of participants that completed health behavior interventions. (time frame: 14-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07833384, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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