Clinical trial NCT03412175: CREATION Health Lifestyle Intervention
Official title: CREATION Health Lifestyle Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood Pressure
timeFrame: 6 months
measure: Hemoglobin A1C
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
Study officials:
affiliation: Center for CREATION Health Research
name: Patricia Robinson
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Spring B, Ockene JK, Gidding SS, Mozaffarian D, Moore S, Rosal MC, Brown MD, Vafiadis DK, Cohen DL, Burke LE, Lloyd-Jones D; American Heart Association Behavior Change Committee of the Council on Epidemiology and Prevention, Council on Lifestyle and Cardiometabolic Health, Council for High Blood Pressure Research, and Council on Cardiovascular and Stroke Nursing. Better population health through behavior change in adults: a call to action. Circulation. 2013 Nov 5;128(19):2169-76. doi: 10.1161/01.cir.0000435173.25936.e1. Epub 2013 Oct 7. No abstract available.