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

October 5, 2009
April 1, 2013
October 2009
September 2011   (final data collection date for primary outcome measure)
Cardiovascular structure and function [ Time Frame: Measured at 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00990457 on ClinicalTrials.gov Archive Site
Body composition [ Time Frame: Measured at 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluating the Effects Two Diets Combined With Exercise in Persons With Abdominal Obesity (The SHAPE5 Study)
Two Diets With Exercise in Abdominal Obesity: Cardiovascular Effects

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Overweight
  • Obese
  • Sedentary
  • Abdominal Obesity
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-carbohydrate Diet Plus Exercise
    Participants will follow a low-carbohydrate weight loss diet plus participate in a supervised exercise training program for 6 months.
    Intervention: Behavioral: Weight Loss Diets Plus Exercise
  • 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.
    Intervention: Behavioral: Weight Loss Diets Plus Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
30 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00990457
682, 5R01HL092280, 1R01 092280
Yes
Kerry Stewart, National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Kerry J Stewart, EdD Johns Hopkins University
Johns Hopkins University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP