The Effect of Providing Genetic Risk Information on Lifestyle Behaviors in African Americans (LINKING GAINS)
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.
Обзор исследования
Статус
Условия
- Сердечная недостаточность
- Гипертония
- Диабет
- Генетика
- Гиперхолестеринемия
- Сердечные аритмии
- Фармакогеномика
- Генетика рака
- Ожирение и избыточный вес
- Генетика Гипертония
- ИБС - ишемическая болезнь сердца
- Риск инсульта
- Фармакогеномное тестирование для управления лекарствами
- Ожирение Сахарный диабет 2 типа
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Ранняя фаза 1
Контакты и местонахождение
Места учебы
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Louisiana
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Baton Rouge, Louisiana, Соединенные Штаты, 70808
- Pennington Biomedical Research Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Genetically Unblinded
Genetically 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. |
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. |
|
Экспериментальный: Genetically Blinded
Genetically 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. |
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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Total number of participants that completed health behavior interventions.
Временное ограничение: 14-weeks
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Measured by total health behavior sessions attended between groups. |
14-weeks
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Соавторы и исследователи
Следователи
- Главный следователь: Jennifer L. Caldwell, PhD, MPH, MS, Pennington Biomedical Research Center
Публикации и полезные ссылки
Общие публикации
- 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.
- Carnethon MR, Pu J, Howard G, Albert MA, Anderson CAM, Bertoni AG, Mujahid MS, Palaniappan L, Taylor HA Jr, Willis M, Yancy CW; American Heart Association Council on Epidemiology and Prevention; Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Functional Genomics and Translational Biology; and Stroke Council. Cardiovascular Health in African Americans: A Scientific Statement From the American Heart Association. Circulation. 2017 Nov 21;136(21):e393-e423. doi: 10.1161/CIR.0000000000000534. Epub 2017 Oct 23.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания эндокринной системы
- Сосудистые заболевания
- Сердечно-сосудистые заболевания
- Расстройства питания
- Сердечные заболевания
- Метаболические заболевания
- Переедание
- Масса тела
- Нарушения метаболизма глюкозы
- Гиперлипидемии
- Дислипидемии
- Нарушения липидного обмена
- Артериосклероз
- Артериальные окклюзионные заболевания
- Коронарная болезнь
- Ишемия миокарда
- Патологические состояния, признаки и симптомы
- Пищевые и метаболические заболевания
- Признаки и симптомы
- Сердечная недостаточность
- Избыточный вес
- Ожирение
- Гипертония
- Сахарный диабет
- Гиперхолестеринемия
- Ишемическая болезнь сердца
Другие идентификационные номера исследования
- PBRC 2024-043
- P50MD017338 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
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.
Сроки обмена IPD
De-identified individual participant data and supporting documentation will become available following publication of the primary study results or within 12 months after study completion, whichever occurs first. Data will remain available for at least five years following publication.
Критерии совместного доступа к IPD
Access to de-identified data will be available to qualified researchers whose proposed use is consistent with the informed consent provided by study participants and applicable institutional policies. Investigators must submit a research proposal, statistical analysis plan, and data use agreement for review and approval by the Pennington Biomedical Research Center study team. Only de-identified data necessary to address the approved research question will be shared. Data will be provided through a secure institutional data-sharing process in accordance with institutional and NIH data-sharing policies.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- АНАЛИТИЧЕСКИЙ_КОД
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .