CREATION Health Lifestyle Intervention (CHLI)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Florida
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Orlando, Florida, Forente stater, 32804
- Florida Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
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.
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Ingen inngripen: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Blood Pressure
Tidsramme: 6 months
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A 6 mm Hg reduction in systolic blood pressure/diastolic blood pressure as measured in clinic in participants diagnosed with Hypertension
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6 months
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Hemoglobin A1C
Tidsramme: 6 months
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A reduction of Hemoglobin A1C in participants diagnosed with Type II Diabetes Mellitus to less than 6% as measured by fasting blood work
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6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Patricia Robinson, Center for CREATION Health Research
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A, Lloyd-Jones DM, Nelson SA, Nichol G, Orenstein D, Wilson PW, Woo YJ; American Heart Association Advocacy Coordinating Committee; Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Arteriosclerosis; Thrombosis and Vascular Biology; Council on Cardiopulmonary; Critical Care; Perioperative and Resuscitation; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease; Council on Cardiovascular Surgery and Anesthesia, and Interdisciplinary Council on Quality of Care and Outcomes Research. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011 Mar 1;123(8):933-44. doi: 10.1161/CIR.0b013e31820a55f5. Epub 2011 Jan 24.
- Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive Summary: Heart Disease and Stroke Statistics--2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):447-54. doi: 10.1161/CIR.0000000000000366. No abstract available.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 878401
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