NCT03412175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

2.3 years

First QC Date

January 19, 2018

Last Update Submit

August 28, 2018

Conditions

Cardiovascular Risk

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Behavioral Intervention

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Behavioral InterventionBEHAVIORAL

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.

Behavioral Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Hospital

Orlando, Florida, 32804, United States

Location

Related Publications (3)

  • 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.

    PMID: 21262990BACKGROUND

  • 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.

    PMID: 26811276BACKGROUND

  • 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.

    PMID: 24100544BACKGROUND

Related Links

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Patricia Robinson

    Center for CREATION Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

January 26, 2018

Study Start

May 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations

US(1)