Mindfulness-based Personalized Health Planning for Reducing Risk of Heart Disease and Diabetes

NCT01430221 | Completed DMC

• 2 other identifiers: Pro00016540R01HL067459
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness of educational and lifestyle intervention programs aimed at reducing fasting blood sugar and emotional distress in adults with prediabetes.

Conditions

Prediabetes; Depressive Symptoms Mild to Moderate in Severity

Keywords

prediabetes; severity of depressive symptoms; mindfulness; personalized health planning; cardiometabolic diseases prevention

Outcome Measures

Primary Outcomes (2)

• Fasting glucose

  Changes from entry levels of fasting glucose up to 45-days post-intervention, and long-term follow-up (\>6-months) levels.

  screening, up to 45-days after completion of intervention, long term follow-up (>6 months)

• Severity of depressive symptoms

  Changes from entry levels of severity of depressive symptoms as assessed via the Hamilton Depression (HAM-D) interview to 45-days after completion of intervention and long-term follow-up (\> 6-months)

  baseline, up to 45-days after completion of intervention, long-term follow-up (>6 months)

Secondary Outcomes (2)

• Reduction in resting blood pressure

  Baseline, up to 45-days after completion of intervention, long-term follow-up (>6 months)

• Changes in inflammation

  baseline, 45-days following completion of intervention and long-term follow-up(>6-months)

Study Arms (2)

MB-PHP Group

EXPERIMENTAL

Mindfulness-based Personalized Health Planning (MB-PHP)with health coaching. MB-PHP includes weekly small group meetings for 22-weeks and 10 bi-weekly telephonic health coaching.

Behavioral: Mindfulness-based Personalized Health Planning

SAGE Group

ACTIVE COMPARATOR

Structure \& Guided Education (SAGE) includes small group-education sessions once per week for 22 weeks. Subjects also participate in 10 bi-weekly telephone calls with education partners who use supportive listening techniques..

Other: Structured & Guided Education

Interventions

Mindfulness-based Personalized Health Planning BEHAVIORAL

Also known as: MB-PHP

MB-PHP Group

Structured & Guided Education OTHER

Also known as: SAGE

SAGE Group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Between 30 and 70 years old 2. Nonsmoker 3. Generally in good health 4. Able to speak and read English 5. Willing to provide informed consent 6. Patient Health Questionnaire-9 (PHQ-9) score greater than 5 (minimal depression) but less than 25 (severe depression) 7. Hemoglobin A1c values between 5.6%-6.4% (inclusive) 9. Able to attend 2 study visits at Duke University Medical Center 10. Able to attend 22 small group education sessions 11. Able to participate in 10 telephonic support sessions

You may not qualify if:

• Younger than 30 years old/Older than 70
• PHQ-9 score of 25 or greater (severe depression) and lower than 5 (no depression)
• \. Hemoglobin A1c below 5.6% or above 6.4% 5. BMI less than 19.1 kg/m2 6. History of cardiovascular diseases (e.g., coronary artery disease, congestive heart failure, prior myocardial infarction or stroke, or more than 4 episodes of chest pain requiring nitroglycerin in the last month) 7. Current smokers or former smokers who quit within the last 6 months 8. Participation in formal group exercise, nutrition, weight loss or stress management program during the study period 9. Severe disease that may make cardiovascular prevention of secondary importance and/or result in severely compromised immune system (e.g., HIV positive, end-stage renal disease requiring dialysis, Hepatitis C) 10. Terminal illness defined as requiring oxygen or diagnosis of malignancy 11. Unstable medical conditions underlying weight or eating problems (e.g., Cushing's Syndrome, thyroid disorder) 12. Use of medications that impact immune, cardiovascular, or metabolic indices (e.g., anti-inflammatory, anti-hypertensives, lipid-lowering medications, oral agents for diabetes, stimulants) 13. Women on exogenous hormone replacement or oral contraceptives 14. Women reporting irregular menstrual cycle over previous 6 months 15. Severe psychiatric conditions or behaviors (e.g., drug or alcohol abuse, psychosis, severe social anxiety, bipolar disorder, Axis II diagnosis) 16. Unwillingness to accept randomization 17. Pregnancy

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Edward Suarez, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 8, 2011
• Study Start: May 1, 2011
• Primary Completion: February 15, 2017
• Study Completion: February 15, 2017
• Last Updated: February 24, 2017

Record last verified: 2017-02

Locations

US (1)