Evaluating the Effects Two Diets Combined With Exercise in Persons With Abdominal Obesity (The SHAPE5 Study)
SHAPE5
Two Diets With Exercise in Abdominal Obesity: Cardiovascular Effects
3 other identifiers
interventional
77
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 5, 2009
CompletedFirst Posted
Study publicly available on registry
October 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedApril 4, 2013
April 1, 2013
1.9 years
October 5, 2009
April 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiovascular structure and function
Measured at 6 months
Secondary Outcomes (1)
Body composition
Measured at 6 months
Study Arms (2)
Low-carbohydrate Diet Plus Exercise
ACTIVE COMPARATORParticipants will follow a low-carbohydrate weight loss diet plus participate in a supervised exercise training program for 6 months.
Low-Fat, Low-Calorie Diet Plus Exercise
ACTIVE COMPARATORParticipants will follow a low-calorie, low-fat weight loss diet plus participate in a supervised exercise training program for 6 months.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kerry J Stewart, EdD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
October 5, 2009
First Posted
October 6, 2009
Study Start
October 1, 2009
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
April 4, 2013
Record last verified: 2013-04