CREATION Health Lifestyle Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-08-31

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.

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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.

Conditions

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Cardiovascular Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Behavioral Intervention

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.

Group Type EXPERIMENTAL

Behavioral Intervention

Intervention Type BEHAVIORAL

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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of Type 2 Diabetes, fasting glucose \>125, or Hg A1C \>6.5% and/or
2. Diagnosis of Hypertension
3. Age 18 or older
4. Agree to participate in all aspects of study intervention and assessments
5. Able to give informed consent
6. Access to home phone or mobile phone

Exclusion Criteria

1. Current use of oral corticosteroids
2. Current use of psychotropics for psychosis or bipolar disorder
3. Use of weight-loss medication in the past 3 months
4. Psychiatric hospitalization in the past 3 years
5. Cancer diagnosis or treatment in the past 3 years
6. History of MI, CABG, stroke, PTCA, balloon pump, etc in past 2 years
7. Hemoglobin A1C 12% or more on two occasion in the past 6 months
8. Pregnancy
9. Severe debilitating medical condition that would interfere with completion of intervention
10. Unable to speak, read, and understand English

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No