search
Back to results

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

Primary Purpose

Overweight, Obese, Sedentary

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Weight Loss Diets Plus Exercise
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring Exercise, Weight loss diet, Obesity, Overweight, Abdominal obesity, Cardiovascular function, Body composition

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low-carbohydrate Diet Plus Exercise

Low-Fat, Low-Calorie Diet Plus Exercise

Arm Description

Participants will follow a low-carbohydrate weight loss diet plus participate in a supervised exercise training program for 6 months.

Participants will follow a low-calorie, low-fat weight loss diet plus participate in a supervised exercise training program for 6 months.

Outcomes

Primary Outcome Measures

Cardiovascular structure and function

Secondary Outcome Measures

Body composition

Full Information

First Posted
October 5, 2009
Last Updated
April 1, 2013
Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00990457
Brief Title
Evaluating the Effects Two Diets Combined With Exercise in Persons With Abdominal Obesity (The SHAPE5 Study)
Acronym
SHAPE5
Official Title
Two Diets With Exercise in Abdominal Obesity: Cardiovascular Effects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese, Sedentary, Abdominal Obesity
Keywords
Exercise, Weight loss diet, Obesity, Overweight, Abdominal obesity, Cardiovascular function, Body composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-carbohydrate Diet Plus Exercise
Arm Type
Active Comparator
Arm Description
Participants will follow a low-carbohydrate weight loss diet plus participate in a supervised exercise training program for 6 months.
Arm Title
Low-Fat, Low-Calorie Diet Plus Exercise
Arm Type
Active Comparator
Arm Description
Participants will follow a low-calorie, low-fat weight loss diet plus participate in a supervised exercise training program for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss Diets Plus Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiovascular structure and function
Time Frame
Measured at 6 months
Secondary Outcome Measure Information:
Title
Body composition
Time Frame
Measured at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry J Stewart, EdD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs