Effect of Weight Loss on Cardiovascular Disease Risk Factors in Obese Women

NCT01353001 | Completed

• 1 other identifier: BSD-UPitt
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effect of weight loss and exercise on cardiovascular disease risk factors, specifically inflammation as measured by C-Reactive Protein and cardiac structure and function as measured by cardiac MRI, in Class II and III obese women during a 12 week training intervention.

Conditions

Obesity; Cardiovascular Diseases

Keywords

Intervention Studies; Magnetic Resonance Imaging; C-Reactive Protein

Outcome Measures

Primary Outcomes (1)

• Cardiovascular Disease Risk Factors

  Inflammation as determined by C-Reactive Protein and Cardiac Structure and Function as defined by left ventricular mass, aortic pulse wave velocity, fibrosis, and ejection fraction.

  0 and 12 weeks

Secondary Outcomes (1)

• Weight Loss

  0 and 12 weeks

Study Arms (3)

Diet Only

EXPERIMENTAL

Behavioral: Diet

Diet plus Aerobic Training

EXPERIMENTAL

Behavioral: Diet Plus Aerobic Training

Diet plus Resistance Training

EXPERIMENTAL

Behavioral: Diet plus Resistance Training

Interventions

Diet BEHAVIORAL

Participants will be given a calorie and fat gram goal according to their initial bodyweight. The fat gram goals will be set at 20% to 30% of total caloric intake. Subject calorie and fat gram goals are as follows: Subjects weighing less than 175 pounds will receive a diet prescription of 1200 calories and 27 fat grams per day. Subjects weighing between 175 and 219 pounds will receive a diet prescription of 1500 calories and 33 fat grams per day. Subjects weighing between 220 and 249 pounds will receive a diet prescription of 1800 calories and 40 fat grams per day. Subjects weighing greater than 250 pounds will receive a diet prescription of 2100 calories and 47 fat grams per day.

Diet Only

Diet Plus Aerobic Training BEHAVIORAL

Participants will receive all of the components as described for the DIET group. Additionally, this group will participate in supervised progressive aerobic training 3 days per week. Participants will be required to attend 3 sessions per week where they will participate in supervised exercise sessions progressing from 60 to 180 minutes per week of moderate-intensity (3.0-6.0 METS) aerobic exercise. 180 minutes per week of exercise will meet the American College of Sports Medicine and the American Heart Association recommendations of 450-750 METS.min.wk-1.

Also known as: DIET+AT

Diet plus Aerobic Training

Diet plus Resistance Training BEHAVIORAL

Participants will receive all of the components as the DIET group. Participants will also participate in supervised resistance training protocol 3 days per week in the form of an individual session. The protocol will start the participants at a low volume of exercise at an intensity of 50-55% of 1-repetition maximum, and oscillate in both volume and intensity during the intervention, with a general trend toward increases in intensity as outlined in the ACSM Position Stand.

Also known as: DIET+RT

Diet plus Resistance Training

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• years of age
• BMI = 35.0-44.9 kg/m2

You may not qualify if:

• Currently pregnant, pregnant in the past 6 months, or planning on becoming pregnant in the next 6 months.
• Regularly exercising for greater than 60 minutes per week.
• Taking prescription or over-the-counter medications that affect body weight, metabolism, blood pressure, or heart rate, such as psychotropic medications (e.g. zoloft, prozac, paxil, xanax) and medications that have metabolic effects (e.g. synthroid, wellbutrin, metformin).
• Having physical limitations that hinder or prevent exercise.
• Currently being treated for coronary heart disease, diabetes mellitus, hypertension, or cancer.
• Having a resting systolic blood pressure of \> 150mmHg of diastolic blood pressure of \> 100mmHg or currently taking any medications that affect blood pressure or heart rate (i.e. beta blockers).
• Currently enrolled in an exercise or weight control study or participating in an exercise or weight control study in the past 6 months.
• Have lost and not regained \> 5% body weight in the past 6 months.
• Currently being treated for any psychological problems or taking any psychotropic medications.
• Abnormal kidney functions, as per current institutional standard for gadolinium administration.
• Known allergy to IV gadolinium, or the discovery of an allergic reaction to IV gadolinium at baseline.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Physical Activity and Weight Management Research Center, Suite 600 Birmingham Towers

Pittsburgh, Pennsylvania, 15203, United States

Location

MeSH Terms

Conditions

Obesity; Cardiovascular Diseases

Interventions

Diet; Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Steven D Verba, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Blake D Justice, MS

  University of Pittsburgh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 12, 2011
• Study Start: April 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: July 1, 2011
• Last Updated: January 5, 2016

Record last verified: 2016-01

Locations

US (1)