CREATION Health Lifestyle Intervention (CHLI)

Objective

To study the effect of a lifestyle intervention program on the blood pressure, body mass index (BMI), and Hemoglobin A1C of participants diagnosed with hypertension and/or type 2 diabetes.

Key Study Personnel:

Patricia S. Robinson, PhD, ARNP – Principal Investigator
Jo Wheeler, RN – CREATION Health Specialist
Pamela J. Jennelle, MS – Coordinator

Number of Participants:

184
(enrollment complete)

Study Population

Participants who met the following criteria were recruited from Longwood Family Health

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
  5. and assessments
  6. Able to give informed consent
  7. Access to home phone or mobile phone

Exclusion Criteria:

  1. Maintenance therapy or continued use of oral corticosteroids
  2. Current use of psychotropics for psychosis or bipolar disorder
  3. Use of weight-loss medications 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 myocardial infarction, coronary artery bypass graft, stroke, PTCA, balloon pump, etc. in the past 2 years
  7. Hemoglobin A1C ≥12% on more than 2 occasions in the past 6 months
  8. Pregnancy
  9. Severe debilitating condition that would interfere with completion of the intervention
  10. Unable to speak, read, and understand English

Intervention:

The intervention consisted of delivery of health coaching using motivational interviewing techniques to provide psychosocial support for behavior change. Using the CREATION Health framework, the participant and coach worked on goal-setting, action plans, self-monitoring, identification of personal and social barriers to change, and self-regulatory techniques. At each visit, goals were continually reviewed and revised based on the participant’s input.

Measurements/Instruments

  • Height – measured with portable stadiometer
  • Weight – measured with portable digital scale
  • Waist Circumference – measured with tape measure
  • Blood Pressure – measured with aneroid blood pressure cuff
  • Hemoglobin A1C – measured with fasting blood work
  • Cholesterol – measured with fasting blood work
  • BMI – computed by OpenClinica (a clinical trial management system) based on height and weight
  • Count of Comorbidities – Charlson Comorbidity Index

Current Status:

Follow-up visits in progress

Targeted Completion Date:

August, 2018

Additional Information:

Questions about Study:
Contact:
Dr. Patricia Robinson
Email: Patricia.S.Robinson@ahss.org