CREATION Health Lifestyle Intervention

Study Overview
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Brief Summary
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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
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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.

Official Title
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CREATION Health Lifestyle Intervention

Conditions
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Cardiovascular Risk

Intervention / Treatment
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* Behavioral: Behavioral Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Type 2 Diabetes, fasting glucose >125, or Hg A1C >6.5% and/or Diagnosis of Hypertension Age 18 or older Agree to participate in all aspects of study intervention and assessments Able to give informed consent Access to home phone or mobile phone Exclusion Criteria: Current use of oral corticosteroids Current use of psychotropics for psychosis or bipolar disorder Use of weight-loss medication in the past 3 months Psychiatric hospitalization in the past 3 years Cancer diagnosis or treatment in the past 3 years History of MI, CABG, stroke, PTCA, balloon pump, etc in past 2 years Hemoglobin A1C 12% or more on two occasion in the past 6 months Pregnancy Severe debilitating medical condition that would interfere with completion of intervention Unable to speak, read, and understand English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Intervention<br>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. | Behavioral: Behavioral Intervention<br>* 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.<br>|
| No Intervention: Control Group<br>Participants in the control group will receive usual care as provided by their primary care physician. Participants in the control group will complete biometrics, surveys, and assessments at Visits 0, 5 and 6. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | A 6 mm Hg reduction in systolic blood pressure/diastolic blood pressure as measured in clinic in participants diagnosed with Hypertension | 6 months | 
| Hemoglobin A1C | A reduction of Hemoglobin A1C in participants diagnosed with Type II Diabetes Mellitus to less than 6% as measured by fasting blood work | 6 months |