An interventional study of Group 1 (Intervention) and Group 2 (Delayed intervention) in Heart Disease, Cardiovascular Disease and Sedentary Lifestyle, sponsored by Cornell University. Completed at 13 sites in United States. Open to female participants aged 40 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-01-05.
Sponsored by Cornell University · Not applicable, Interventional, and Prevention
Strong Hearts for New York is a research study which aims to reduce cardiovascular disease (CVD), improve quality of life, and reduce CVD related health care costs in rural communities. Our aim is to better understand how changes in lifestyle can affect the health of rural women and others in their communities.
There are notable cardiovascular disease (CVD) disparities among people living in rural settings, particularly medically underserved rural areas. Complex factors such as socioeconomic disadvantage, social and cultural dynamics, geographic distances/barriers, and limited access to healthcare, healthy foods, and/or physical activity opportunities contribute to the issue. The objective of Strong Hearts, Healthy Communities (SHHC) is to reduce rural CVD disparities through civic engagement and implementation of a community-based intervention in 11 underserved New York communities. SHHC builds upon a long-standing collaboration with National Institute of Food and Agriculture cooperative extension educators, who will implement the project. There is limited knowledge about how programs and services can move beyond commonly used individual-level approaches-which have limitations in terms of cost, impact, reach, and sustainability-to effectively reduce rural CVD health disparities using an integrated, multi-level, community-engaged approach. The objective of Strong Hearts, Healthy Communities (SHHC) is to address this gap in knowledge and practice by working with residents, practitioners, health educators, local leadership, and other stakeholders in 11 medically underserved rural communities in New York to test a comprehensive program designed to: a) improve diet and physical activity behaviors, b) promote local built environment resources, and c) shift social norms about active living and healthy eating through civic engagement, capacity building, and community based programming.
RANDOMIZED INTERVENTION AND DELAYED INTERVENTION: In the current phase of the project, the efficacy of the SHHC program curriculum will be evaluated in a 24-week delayed intervention trial. The investigators will compare changes in CVD-related anthropometric, physiologic, behavioral, and psychosocial parameters between subjects in 5 intervention and 6 delayed communities in New York State. In addition, changes in behavior, attitudes, and knowledge among SHHC intervention subjects' "social network" will be evaluated.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 182 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Cornell University is the lead sponsor of 96 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Full Intervention participants will meet twice per week for one hour each time, for approximately 6 months. Participants will learn and practice good nutrition and physical activity for improved individual, family and community health.
Behavioral: Group 1 (Intervention)
Delayed intervention participants will participate in the same activities as Group 1 but 6 months after Group 1.
Behavioral: Group 2 (Delayed intervention)
The investigators will evaluate the efficacy of the SHHC curriculum in a 24-week community-based randomized delayed intervention trial. They will compare changes in CVD-related anthropometric, physiologic, behavioral, and psychosocial parameters between subjects in 5 intervention and 6 delayed intervention communities. In addition, the investigators will evaluate changes in behavior, attitudes, and knowledge among SHHC intervention subjects' "social network".
The investigators will evaluate the efficacy of the SHHC curriculum in a 24-week community-based randomized delayed intervention trial. They will compare changes in CVD-related anthropometric, physiologic, behavioral, and psychosocial parameters between subjects in 5 intervention and 6 delayed intervention communities. In addition, the investigators will evaluate changes in behavior, attitudes, and knowledge among SHHC intervention subjects' "social network".
Change in body weight
Time frame: Baseline to 24 weeks
Changes in body weight
Time frame: Baseline to 48 weeks
Changes in blood pressure
Time frame: Baseline to 24 weeks, 48 weeks
Changes in blood lipids
Time frame: Baseline to 24 weeks, 48 weeks
Changes in c-reactive protein
Time frame: Baseline to 24 weeks, 48 weeks
Changes in hemoglobin A1C
Time frame: Baseline to 24 weeks, 48 weeks
Changes in waist circumference
Time frame: Baseline to 24 weeks, 48 weeks
Changes in hip circumference
Time frame: Baseline to 24 weeks, 48 weeks
Changes in 7 day accelerometry
Time frame: Baseline to 24 weeks, 48 weeks
Changes in 7 day dietary recall
Time frame: Baseline to 24 weeks, 48 weeks
Changes in healthy eating self-efficacy assessed by questionnaire
Time frame: Baseline to 24 weeks, 48 weeks
Changes in exercise self-efficacy assessed by questionnaire
Time frame: Baseline to 24 weeks, 48 weeks
Changes in healthy eating attitudes of social network of participants assessed by questionnaire
Time frame: Baseline to 24 weeks, 48 weeks
Changes in exercise attitudes of social network of participants assessed by questionnaire
Time frame: Baseline to 24 weeks, 48 weeks
Changes in healthy eating self-efficacy of social network of participants assessed by questionnaire
Time frame: Baseline to 24 weeks, 48 weeks
Changes in exercise self-efficacy of social network of participants assessed by questionnaire
Time frame: Baseline to 24 weeks, 48 weeks
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Cornell University