Effects of Health Promoting Programs on Cardiovascular Disease Risk

NCT02019953 | Completed DMC

• 1 other identifier: 2010-0057
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief Summary

The overall approach to the study is to assess the feasibility of recruiting African Americans to participate in several health-promoting programs and to compare health outcomes among the three interventions.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Primary outcomes for this feasibility study will focus on composite measures for recruitment, retention, and the reasons for refusal or dropout.

  Primary outcomes for this feasibility study will focus on measures for recruitment, retention, and the reasons for refusal or dropout, and consist of (1) agreement to participate in the study (recruitment); (2) reasons for participating/not-participating; (3) dropout, defined as a monotone missingness pattern of stopping participation before completion of the study; (4) reasons for discontinuation/dropout; (5) attendance, defined as the potentially non-monotone pattern of coming to the scheduled study session; and (6) adherence, defined as attending and completing the scheduled sessions and clinical visits.

  Bi-annual for up to 52 weeks after enrollment

Secondary Outcomes (5)

• Changes in participants' hypertension profiles.

  48 weeks

• Changes in participants' inflammation markers

  48 weeks

• Changes in participants' lipids profiles.

  48 weeks

• Changes in participants' HbA1c levels.

  48 weeks

• Changes in participants' reported health-related quality of life.

  48 weeks

Study Arms (5)

Yoga 3 times per week

OTHER

Yoga participation 3 x per week for 24 weeks; 48 week follow-up.

Other: Yoga

Yoga 2 times per week

OTHER

Yoga participation 2 x per week for 24 weeks; 48 week follow-up

Other: Yoga

Yoga 1 time per week

OTHER

Yoga participation 1 x per week for 24 weeks; 48 week follow-up

Other: Yoga

Walking 3 times per week

OTHER

Walking 3x per week for 24 weeks; 48 week follow-up

Other: Walking

Healthy Lifestyles Education

OTHER

Healthy Lifestyles Education Participation 1 x per week for 24 weeks; 48 week follow-up

Other: Healthy Lifestyles Education

Interventions

Yoga OTHER

The yoga intervention, which is taught based on Hatha yoga, will be offered to study participants in Study Arms 1, 2, and 3, is a combination of asanas (poses), pranayams (breathing exercises), and meditation. Blood pressure and heart rate measurements are taken before and after each session.

Yoga 1 time per week; Yoga 2 times per week; Yoga 3 times per week

Walking OTHER

The walking intervention, which is Study Arm 4 includes, three guided walking sessions per week for 24 weeks. Each class is an hour in length and will include a minimum of 30 minutes of walking at the equivalent of a minimum of three miles per hour. Each session includes a ten-minute warm-up and ten-minute cool-down period of some stretches and walking at a leisurely pace. Blood pressure and heart rate measurements are taken before and after each session.

Walking 3 times per week

Healthy Lifestyles Education OTHER

Participants randomly assigned to the fifth study arm attend one 60-minute healthy lifestyles class per week for 24 weeks. The Healthy Lifestyles curriculum includes 24 independent lesson modules, which allows participants to begin their intervention at any time during the course schedule. Blood pressure and heart rate measurements are taken before and after each session.

Also known as: Health Education

Healthy Lifestyles Education

Eligibility Criteria

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

You may not qualify if:

• \. Newly diagnosed (within the last six weeks) with a myocardial infarction, cerebrovascular disease, atrial fibrillation, cardiomyopathy, valvular heart disease, fatal cardiac arrhythmia, severe systolic and diastolic heart failure, uncontrolled COPD, uncontrolled moderate to severe hypertension, or a recent recipient of a pacemaker, and/or
• \. Change in blood pressure medicine or lipid-lowering medication up to 30 days prior to or plans for a change in the 30 days after enrollment in the study, and/or
• \. Already practicing yoga at least once per week or walking briskly for one hour at least three times per week, and/or
• \. Inability to attend protocol sessions, and/or
• \. Diagnosis of an underlying medical illness that might be considered by the principal investigator to potentially impair one's safety or ability to complete the study protocol (example could possibly include uncontrolled asthma), and/or
• \. Current use of a prescription regimen that might be considered by the principal investigator to potentially impair one's safety or ability to complete the study protocol (examples could possibly include use of sedatives or other drugs that could affect a participant's ability to participate in any of the study arms).
• \. Pregnant or planning to become pregnant in the next six (6) months.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Yoga; Walking

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Gailen D Marshall, MD, PhD

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: December 24, 2013
• Study Start: July 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 8, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)