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Evaluating the Effects Two Diets Combined With Exercise in Persons With Abdominal Obesity (The SHAPE5 Study)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kerry Stewart, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00990457
First received: October 5, 2009
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

Abdominal obesity, which is affected by a lack of physical activity and excess weight, put people at an increased risk of cardiovascular disease. This study will compare the effects of two different dietary approaches to weight loss, each combined with exercise, for their effects on cardiovascular factors that are early predictors of future cardiovascular disease in overweight and obese people with excessive weight around their waist. The two diets are a low-carbohydrate versus a more traditional low-fat, low calorie diet.


Condition Intervention Phase
Overweight
Obese
Sedentary
Abdominal Obesity
Behavioral: Weight Loss Diets Plus Exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Two Diets With Exercise in Abdominal Obesity: Cardiovascular Effects

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Cardiovascular structure and function [ Time Frame: Measured at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: Measured at 6 months ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low-carbohydrate Diet Plus Exercise
Participants will follow a low-carbohydrate weight loss diet plus participate in a supervised exercise training program for 6 months.
Behavioral: Weight Loss Diets Plus Exercise

The weight loss diet will be either a low-carbohydrate diet or a low-fat, low-calorie diet. All participants will also be enrolled in a supervised exercise program.

The supervised exercise training sessions will take place three times a week for 6 months. Each session will last 1 to 1 ½ hours and will include aerobic exercise and weight training.

Active Comparator: Low-Fat, Low-Calorie Diet Plus Exercise
Participants will follow a low-calorie, low-fat weight loss diet plus participate in a supervised exercise training program for 6 months.
Behavioral: Weight Loss Diets Plus Exercise

The weight loss diet will be either a low-carbohydrate diet or a low-fat, low-calorie diet. All participants will also be enrolled in a supervised exercise program.

The supervised exercise training sessions will take place three times a week for 6 months. Each session will last 1 to 1 ½ hours and will include aerobic exercise and weight training.


Detailed Description:

Abdominal obesity is a condition that is largely influenced by a poor diet and physical inactivity. This condition has adverse effects on heart and blood vessel structure and function, including left ventricular diastolic dysfunction, endothelial vasodilator dysfunction, and increased vascular stiffness, each of which increase the risk of cardiovascular disease. Reducing the amount of calories consumed and increasing physical activity are both important factors for losing weight, increasing fitness, and improving blood glucose control. However, little research has been conducted on comparing different diet approaches combined with exercise for their effects on general and abdominal obesity, fitness, heart and blood vessel structure and function, and heart disease risk factors. The purpose of this study is to determine whether people who follow low-carbohydrate diet or a low-fat, low-calorie diet, each combined with a supervised experience similar improvements in cardiovascular and in body composition and health.

This study will enroll people who are overweight or obese and abdominal obesity, defined as a waist to hip ratio greater than 1, or a waist size of 40" or greater in men or 35" or greater in women. Participants will attend baseline study visits and complete blood pressure measurements; muscle strength measurements; a treadmill test to evaluate cardiovascular fitness; an echocardiogram to obtain images of the heart; tests to measure blood vessel function; a dual energy x-ray absorptiometry (DEXA) scan to measure body fat, muscle tissue, and bone density; questionnaires to assess physical activity levels, quality of life, and mood; and a blood collection. A portion of blood will be stored for future genetic testing. Women will also provide a urine sample for pregnancy testing. Participants will also keep a food diary for 3 days. Participants will then be randomly assigned to either a low-carbohydrate or a low-fat, low-calorie weight loss diet, each combined with a supervised exercise program. . The exercise program will be done three times a week for 6 months. Each session will last 1 to 1 ½ hours and will include aerobic exercise and weight training.

All participants will attend study visits with a dietitian for weight loss counseling and monitoring once a week during Months 1 and 2, and every other week in Months 3 through 6. At each of these visits, participants' weight will be measured.

At the end of Month 6, all participants will attend a study visit for repeat baseline testing. In addition, there will another test for vascular function, BP, weight, and waist and hip measurements at the time a participant loses ten pounds.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 30-65 years old
  • Body mass index (BMI) of 25-42 kg/m^2
  • Waist of 35 inches or greater in women and 40 inches or greater in men; or, a
  • Waist-hip ratio greater than 1.

Exclusion Criteria:

  • Currently smokes
  • History or evidence of cardiovascular disease or other major chronic illness
  • Currently exercising regularly or following a weight loss diet
  • Diabetes
  • Uncontrolled high blood pressure
  • Any illness that would prevent participation in a moderate-intense exercise program
  • Pregnant
  • Substance abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990457

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Kerry J Stewart, EdD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Kerry Stewart, Professor of Medicine, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00990457     History of Changes
Other Study ID Numbers: 682, 5R01HL092280, 1R01 092280
Study First Received: October 5, 2009
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Johns Hopkins University:
Exercise
Weight loss diet
Obesity
Overweight
Abdominal obesity
Cardiovascular function
Body composition

Additional relevant MeSH terms:
Obesity
Obesity, Abdominal
Overweight
Body Weight
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014