Johns Hopkins University
Baltimore, Maryland, 21205, United States
NCT Number: NCT06257550
THRIVE intervention is a 2-arm randomized pilot trial testing the feasibility and preliminary efficacy of producing prescriptions, tailored dietitian counseling with adaptive messages, and linkages to social resources among 80 Black adults with hypertension.
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Notify Me18 year–79 year
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21205, United States
Nearly 55% of Black adults have hypertension and uncontrolled blood pressure. Dietary Approaches to Stop Hypertension (DASH) promotes a dietary pattern rich in fruits and vegetables (fruits and vegetables), low-fat dairy, lean meats with reduced saturated fat, and sweets, which is effective in lowering blood pressure. The proposed THRIVE intervention will enroll 80 Black adults with hypertension living in Healthy Food Priority Areas (HFPAs) in a 2-arm randomized pilot study. One group will receive Produce prescriptions, personalized dietitian coaching, and adaptive bi-directional messaging; the other group will receive standard produce bags. Both groups will be linked to needed social services.
The investigators will assess changes in overall DASH adherence, acceptability, and feasibility at 3- and 6-months post-randomization. The investigators will: 1) Develop and beta test THRIVE among Black adults with hypertension living in HFPAs; 2) Test feasibility and preliminary efficacy of THRIVE at 6 & 12 weeks; 3) Determine short-term sustainability of THRIVE at 6 months.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
THRIVE Intervention includes:
The Active Comparator arm will receive standard produce bags through our food is medicine partner, and will receive the linkages to needed social and health resources intervention components.
Time frame: 0, 12 weeks and 24 weeks
Adherence will be assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24). The scores range from 0 to 100, with higher scores reflecting greater adherence.
Time frame: 0, 12 weeks, 24 weeks
Recruitment yield per time
Time frame: 0, 12 weeks, 24 weeks
Intervention cost/person will be estimated based on the cost of the intervention
Time frame: 0, 12 weeks and 24 weeks
Referrals, participation rates, and recruitment yields.
Time frame: 0, 12 weeks and 24 weeks
Social needs as assessed by the number of participants connected to health services and services for social needs.
Time frame: 0, 12 and 24 weeks
Blood pressure measured in millimeters of mercury (mmHg)
Time frame: 0, 12 and 24 weeks
Blood pressure measured in millimeters of mercury (mmHg)
Time frame: 0, 12 and 24 weeks
Hemoglobin A1c (percent)
Time frame: 0, 12 and 24 weeks
Height will be measured
Time frame: 0, 12 weeks and 24 weeks
Weight will be measured
Johns Hopkins University
Other
THRIVE: AdapTive Personalized Dietitian coacHing, Messaging and pRoduce prescrIption to improVE Healthy Dietary Behaviors
Acronym: THRIVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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