Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT06358417
The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced community health worker (CHW) intervention for primary care patients with nutrition insecurity and poorly controlled hypertension. The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension (Basic CHW) program that provides hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months.
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Notify Me21 year–99 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced CHW intervention in primary care patients with nutrition insecurity and poorly controlled hypertension. The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension (Basic CHW) that provides basic hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months. The CHW nutrition intervention curriculum is tailored to the needs and preferences of a food-insecure population with limited resources. Nutrition education materials will be provided to participants, including a booklet of nutrition information and a summarized version of key points on a brochure that they can use as a quick reference when grocery shopping. Nutrition education will focus on reducing sodium, saturated fats, and added sugars and increasing fruits, vegetables, and whole grains. Much of the educational material is based on a traffic-light system. These topics are organized into four modules: nutrition label reading, grocery shopping, meal-planning, and healthy cooking.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CHW provides nutrition education and skills training in addition to the usual care (Basic CHW) hypertension management.
CHW provide usual care for hypertension management.
Time frame: Baseline
Proportion of eligible participants enrolled in study
Time frame: 4 months
At least 70% participants complete at least 3 of 4 CHW nutrition education modules
Time frame: 4 months
Average of participants' ratings of intervention components on a 10-point scale.
Time frame: 4 months
Change in Healthy Eating Index-20 score
Time frame: 4 months
Change in systolic and diastolic blood presure
Time frame: 4 months
At least 70% participants complete 3 of 6 nutrition worksheets
Time frame: 4 months
At least 70% participants have a CHW assessment of their home cooking environment
Massachusetts General Hospital
Other
CHW Intervention to Improve Nutrition Security of Primary Care Patients With Hypertension
Acronym: HeartWell
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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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