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Effect of Exercise and Weight Loss on Cardiovascular Health

NCT01500356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 383

Last updated 2017-07-25

No results posted yet for this study

Summary

The primary aim of this study is to examine the effect of the consensus public health recommended level of physical activity \[moderate physical activity (MOD-PA) = 150 min/wk\] versus a higher dose of physical activity \[high physical activity (HIGH-PA) = 250 min/wk\] in the context of a comprehensive behavioral weight loss program that a includes a reduction in energy intake measures of cardiovascular function using cardiac MRI and biomarkers of vascular disease risk. Each of these exercise doses will be compared independently to a Diet Only group intervention on the proposed primary and secondary outcomes, with MOD-PA also compared to HIGH-PA. This study involves the recruitment of 390 overweight and obese adults who will be randomly assigned to one of the above conditions (Diet Only, MOD-PA, HIGH-PA) for a period of 12 months. The primary outcome is LVM measured by cardiac MRI. Secondary outcomes include additional cardiac MRI measures (aortic pulse wave velocity, end diastolic volume, aortic distensibility), inflammatory markers (CRP and TNFα) and selected adipocytokines (adiponectin) as biomarkers of risk related to vascular outcomes, body weight, body composition, and cardiorespiratory fitness, and traditional CVD risk factors (lipids, glucose, insulin, blood pressure). Additional secondary analyses will allow for examination of the effects of physical activity independent of weight change on the primary and secondary outcomes.

Conditions

Interventions

BEHAVIORAL

Behavioral weight loss intervention

Weight loss intervention that focuses on reducing energy intake.

BEHAVIORAL

Diet Plus Moderate Exercise

Weight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 150 minutes per week of moderate-intensity exercise.

BEHAVIORAL

Diet Plus High Exercise

Weight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 250-300 minutes per week of moderate-intensity exercise.

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • John M. Jakicic, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-13
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01500356 on ClinicalTrials.gov