OverweightPhase 3SHAPE5NCT00990457
Evaluating the Effects Two Diets Combined With Exercise in Persons With Abdominal Obesity (The SHAPE5 Study)
A Phase 3 study testing Weight Loss Diets Plus Exercise in people with Overweight and Obese, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obese, Sedentary
- What is being tested?
- Weight Loss Diets Plus Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Sep 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight, Obese, Sedentary, Abdominal Obesity
- Being tested
- Weight Loss Diets Plus Exercise
- Keywords
- Exercise, Weight loss diet, Obesity, Overweight, Abdominal obesity, Cardiovascular function, Body composition
- Medical subject headings
- Overweight, Obesity, Sedentary Behavior, Obesity, Abdominal, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight Loss Diets Plus ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-carbohydrate Diet Plus Exercise | Active comparator | Participants will follow a low-carbohydrate weight loss diet plus participate in a supervised exercise training program for 6 months. Receives: Behavioral: Weight Loss Diets Plus Exercise |
| Low-Fat, Low-Calorie Diet Plus Exercise | Active comparator | Participants will follow a low-calorie, low-fat weight loss diet plus participate in a supervised exercise training program for 6 months. Receives: Behavioral: Weight Loss Diets Plus Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular structure and function
Measured: Measured at 6 months
Secondary outcomes (1)
Body composition
Measured: Measured at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Kerry Stewart, National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Kerry J Stewart, EdD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990457
- Sponsor's protocol ID
- 682
- Other IDs
- 5R01HL092280, 1R01 092280
- Acronym
- SHAPE5
- Status last verified
- Apr 2013
- First submitted
- 5 Oct 2009
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Diets With Exercise in Abdominal Obesity: Cardiovascular Effects
- ClinicalTrials.gov ID
- NCT00990457
- Acronym / sponsor ID
- SHAPE5 / 682
- Conditions
- Overweight, Obese, Sedentary, Abdominal Obesity
- Keywords
- Exercise, Weight loss diet, Obesity, Overweight, Abdominal obesity, Cardiovascular function, Body composition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 6 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-carbohydrate Diet Plus Exercise | Active comparator | Behavioral: Weight Loss Diets Plus ExerciseParticipants 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 comparator | Behavioral: Weight Loss Diets Plus ExerciseParticipants will follow a low-calorie, low-fat weight loss diet plus participate in a supervised exercise training program for 6 months. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight Loss Diets Plus ExerciseThe 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. | Behavioural | Low-Fat, Low-Calorie Diet Plus Exercise, Low-carbohydrate Diet Plus Exercise |
Primary outcome
Cardiovascular structure and function
Time frame: Measured at 6 months
1 secondary outcome
Body composition
Time frame: Measured at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerry J Stewart, EdD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Weight Loss Diets Plus Exercise in people with Overweight and Obese, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular structure and function (time frame: Measured at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.