Effect of Exercise and Weight Loss on Cardiovascular Health

NCT01500356 | Completed DMC

• 1 other identifier: HL103646
• Study Type: interventional
• Target: 383
• Locations: 1 country
• Sites: 1

Brief 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

Cardiovascular Disease; Obesity

Keywords

cardiovascular disease; obesity; exercise

Outcome Measures

Primary Outcomes (1)

• Change in Left ventricular mass assessed using cardiac MRI

  Left ventricular mass will be assessed using cardiac MRI

  Baseline (0 months) and 12 months

Secondary Outcomes (10)

• Change in end-diastolic volume assessed using cardiac MRI

  baseline (0 months) and 12 months

• Change in cardiorespiratory fitness

  baseline (0 months) 6 months, and 12 months

• Change in blood levels of C-Reactive Protein (CRP)

  baseline (0 months), 6 months, and 12 months

• Change in body weight

  baseline (0 months), 6 months, and 12 months

• Change in body composition

  baseline (0 months), 6 months, and 12 months

Study Arms (3)

Diet alone

EXPERIMENTAL

Weight loss intervention that focuses only on reducing energy intake of the diet.

Behavioral: Behavioral weight loss intervention

Diet plus Moderate Exercise

EXPERIMENTAL

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 Moderate Exercise

Diet Plus High Exercise

EXPERIMENTAL

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.

Behavioral: Diet Plus High Exercise

Interventions

Behavioral weight loss intervention BEHAVIORAL

Weight loss intervention that focuses on reducing energy intake.

Diet alone

Diet Plus Moderate Exercise BEHAVIORAL

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.

Diet plus Moderate Exercise

Diet Plus High Exercise BEHAVIORAL

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.

Diet Plus High Exercise

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age.
• Body mass index (BMI) between 25.0 to \<40.0 kg/m2.
• Ability to provide informed consent prior to participation in this study.

You may not qualify if:

• Females who are currently pregnant or breastfeeding, or reporting that she is planning a pregnancy within the next 12 months.
• History of bariatric surgery.
• Report current medical condition or treatment for a medical condition that could affect body weight. These may include the following: cancer (Note: Persons previously diagnosed with non-melanoma skin cancers, those successfully treated for cancer who have remained disease-free for five years or more would be eligible for participation in this study); diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic renal insufficiency; chronic liver disease; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes; etc.
• Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e. recent or recurrent DVT).
• Resting systolic blood pressure of \>160 mmHg or resting diastolic blood pressure of \>100 mmHg.
• Eating disorders that would contraindicate weight loss or physical activity.
• Alcohol or substance abuse.
• Currently treated for psychological issues (i.e., depression, bipolar disorder, etc), taking psychotropic medications within the previous 12 months, or hospitalized for depression within the previous 5 years.
• Report exercise on \>3 days per week for \>20 minutes per day over the past 3 months. (NOTE: It is important that individuals are sedentary when entering this study to allow for maximal effect of the intervention.)
• Report weight loss of \>5% or participating in a weight reduction diet in the past 3 months.
• Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance to at least 80 percent of the scheduled intervention sessions and all of the scheduled assessments.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

• Jakicic JM, Rogers RJ, Lang W, Gibbs BB, Yuan N, Fridman Y, Schelbert EB. Impact of weight loss with diet or diet plus physical activity on cardiac magnetic resonance imaging and cardiovascular disease risk factors: Heart Health Study randomized trial. Obesity (Silver Spring). 2022 May;30(5):1039-1056. doi: 10.1002/oby.23412.

  PMID: 35470972 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Obesity; Motor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• John M. Jakicic, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 28, 2011
• Study Start: December 13, 2011
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: July 25, 2017

Record last verified: 2017-07

Locations

US (1)