NCT03412175

CREATION Health Lifestyle Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: AdventHealth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cardiovascular Risk

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Intervention	The CREATION Health Specialist (CHS) will review with the participant his/her biometrics, assessments, and surveys. The CHS will identify the participant's strengths and weaknesses thereby tailoring the intervention care plan to the participant. Together the participant and CHS will work on goal-setting, action plans, self-monitoring, identification of personal and social barriers to change, and self-regulatory techniques.

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2018-01-26
• Last updated: 2018-08-29

Locations

1 site across 1 country: United States