Cardiovascular Risk Clinical Trial
Official title:
CREATION Health Lifestyle Intervention
The CREATION Health Lifestyle Intervention (CHLI) will study the effect of a lifestyle intervention program on the cardiovascular risk profile (blood pressure, BMI, and Hemoglobin A1C) of participants diagnosed with hypertension and/or type 2 diabetes.
The CREATION Health Lifestyle intervention is targeted at improving the cardiovascular risk
profiles (blood pressure, BMI, and Hemoglobin A1C) of participants diagnosed with
hypertension and/or type 2 diabetes. The intervention is designed to address the whole person
and is based on the CREATION Health framework. Participants in the lifestyle intervention arm
will receive 6 individual visits with a CREATION Health Specialist over a 3 month period, and
one follow up visit at 6 months. The visits include one 2 hour-long initial assessment, four
60-minute motivational interview sessions, and two 60-minute reassessments. Visits will focus
on tailoring the intervention care plan to each individual, goal-setting, action plans,
self-monitoring, identification of personal and social barriers to change, self-regulatory
techniques, and provision of psychosocial support using motivational interviewing techniques.
Using the CREATION Health framework, the CREATION Health Specialist will educate the
participant and make recommendations for lifestyle modifications that lead to reduction in
cardiovascular disease risk by focusing on: reduced energy intake, primarily via lowering fat
intake to <30% of caloric intake; increased physical activity to 150 minutes per week;
smoking cessation; limited sodium intake; and limited alcohol intake.
Intervention fidelity will be determined by tracking the content of visits on encounter
forms. There will also be a quality assurance assessment by audio-taping a select number of
CHS-patient visits. The audiotapes will be reviewed by the study team and CHS for adherence
to study intervention protocols.
Participants in the intervention group will also receive a health journal to document
progress and a CREATION Health workbook that introduces the CREATION Health framework in more
detail. The workbook explains each concept of the CREATION Health framework: Choice; Rest;
Environment; Activity; Trust in God; Interpersonal relationships; Outlook; and Nutrition.
Participants in the intervention group will receive a CREATION Health One-sentence Journal.
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