Cardiovascular DiseasesPhase 3NCT00000519
Exercise Training and Plasma Lipoproteins in Man
A Phase 3 study testing diet, reducing, exercise and diet, fat-restricted in people with Cardiovascular Diseases and Coronary Disease, run by Stanford University.
Trial summary
To determine the effects in moderately obese subjects of weight loss by combined dieting and exercise training on risk factors for coronary artery disease including lipoprotein lipids, apoproteins and blood pressure. Read more about this study
- Who is it for?
- Ages 25 to 49 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- What is being tested?
- diet, reducing, exercise and diet, fat-restricted
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1982to not given
- 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 25 to 49 years
- All sexes
- No healthy volunteers
- Adult
Men and women, ages 25-49. Subjects were overweight with blood pressure less than 160/95 mm Hg and total cholesterol less than 260 mm/dl.
About this study
To determine the effects in moderately obese subjects of weight loss by combined dieting and exercise training on risk factors for coronary artery disease including lipoprotein lipids, apoproteins and blood pressure.
Read the detailed description
BACKGROUND:
Evidence appears to be fairly conclusive that obesity has adverse effects on health and longevity when the relative body weight is 40 percent above desirable weight based on insurance industry tables of weights. The close association between obesity, hypertension, hypercholesterolemia, non-insulin dependent diabetes mellitus, an excess of certain cancers and other medical problems makes it imperative that interventions be directed to change the lifestyles and behaviors of individuals who are overweight. The Stanford Weight Control Project (SWCP) trial examined the effects of weight loss on cardiovascular disease risk factors.
The Stanford Weight Control Project (SWCP) randomized 155 overweight, sedentary, non-smoking men, aged 30-59 years, to one of three groups. Fifty-one were assigned to weight loss through dieting, 52 to weight loss through exercise, and 52 to a control, non-intervention group. Follow-up continued through July 1989.
DESIGN NARRATIVE:
Subjects were randomized to a control group, a hypocaloric National Cholesterol Education Program (NCEP) diet, or to a hypocaloric NCEP diet with exercise. One hundred nineteen of the men and 112 of the women returned for testing after one year.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Hypertension, Myocardial Ischemia, Obesity
- Being tested
- diet, reducing, exercise, diet, fat-restricted
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Hypertension, Myocardial Ischemia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet, reducingBehavioural
exerciseBehavioural
diet, fat-restrictedBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startJul 1982
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Prevention
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000519
- Sponsor's protocol ID
- 38
- Other IDs
- R01HL024462
- Status last verified
- Jun 2013
- First submitted
- 27 Oct 1999
- Last updated
- 26 Jun 2013
- Results posted
- No
Publications
Camargo CA Jr, Vranizan KM, Dreon DM, Frey-Hewitt B, Wood PD. Alcohol, calorie intake, and adiposity in overweight men. J Am Coll Nutr. 1987 Jun;6(3):271-8. doi: 10.1080/07315724.1987.10720189.
PubMed 3598024Stefanick ML, Frey-Hewitt B, Hoover CA, et al: The Effect of Active Weight Loss Achieved by Dieting Versus Exercise on Postheparin Hepatic and Lipoprotein Lipase Activity. In: Human Obesity. Wurtman RJ and Wurtman JJ, (Eds.), New York, The New York Academy of Sciences, 338-339, 1987.
Stefanick ML, Terry RB, Haskell WL, et al: Relationships of Changes in Postheparin Hepatic and Lipoprotein Lipase Activity to HDL-Cholesterol Changes Following Weight Loss Achieved by Dieting Versus Exercise. In: Cardiovascular Disease. Molecular and Cellular Mechanisms, Prevention and Treatment. Gallo LL, (Ed), New York, Plenum Press, 61-68, 1987.
Williams PT, Fortmann SP, Terry RB, Garay SC, Vranizan KM, Ellsworth N, Wood PD. Associations of dietary fat, regional adiposity, and blood pressure in men. JAMA. 1987 Jun 19;257(23):3251-6.
PubMed 3586249Dreon DM, Frey-Hewitt B, Ellsworth N, Williams PT, Terry RB, Wood PD. Dietary fat:carbohydrate ratio and obesity in middle-aged men. Am J Clin Nutr. 1988 Jun;47(6):995-1000. doi: 10.1093/ajcn/47.6.995.
PubMed 3376914Fortmann SP, Haskell WL, Wood PD. Effects of weight loss on clinic and ambulatory blood pressure in normotensive men. Am J Cardiol. 1988 Jul 1;62(1):89-93. doi: 10.1016/0002-9149(88)91370-7.
PubMed 3381757Haskell WL, Stefanick ML, Superko HR: Influence of Exercise on Plasma Lipids and Lipoproteins. In: Exercise, Nutrition, and Energy Metabolism. Horton ES and Terjung RL, (Eds.), New York, Macmillan, 213-227, 1988.
Krauss RM, Williams PT, Lindgren FT, Wood PD. Coordinate changes in levels of human serum low and high density lipoprotein subclasses in healthy men. Arteriosclerosis. 1988 Mar-Apr;8(2):155-62. doi: 10.1161/01.atv.8.2.155.
PubMed 3348757Kris-Etherton PM, Krummel D, Russell ME, Dreon D, Mackey S, Borchers J, Wood PD. The effect of diet on plasma lipids, lipoproteins, and coronary heart disease. J Am Diet Assoc. 1988 Nov;88(11):1373-400.
PubMed 2846672Wood PD, Stefanick ML, Dreon DM, Frey-Hewitt B, Garay SC, Williams PT, Superko HR, Fortmann SP, Albers JJ, Vranizan KM, et al. Changes in plasma lipids and lipoproteins in overweight men during weight loss through dieting as compared with exercise. N Engl J Med. 1988 Nov 3;319(18):1173-9. doi: 10.1056/NEJM198811033191801.
PubMed 3173455Terry RB, Wood PD, Haskell WL, Stefanick ML, Krauss RM. Regional adiposity patterns in relation to lipids, lipoprotein cholesterol, and lipoprotein subfraction mass in men. J Clin Endocrinol Metab. 1989 Jan;68(1):191-9. doi: 10.1210/jcem-68-1-191.
PubMed 2909551Wood PD: Effects of Habitual Exercise on Lipoprotein Metabolism. In: Biological Effects of Physical Activity. Williams RS, Wallace AG, (Eds.), Champaign, IL, Human Kinetics Books, 45-54, 1989.
King AC, Frey-Hewitt B, Dreon DM, Wood PD. Diet vs exercise in weight maintenance. The effects of minimal intervention strategies on long-term outcomes in men. Arch Intern Med. 1989 Dec;149(12):2741-6. doi: 10.1001/archinte.149.12.2741.
PubMed 2596943Frey-Hewitt B, Vranizan KM, Dreon DM, Wood PD. The effect of weight loss by dieting or exercise on resting metabolic rate in overweight men. Int J Obes. 1990 Apr;14(4):327-34.
PubMed 2361810Wood PD, Stefanick ML, Williams PT, Haskell WL. The effects on plasma lipoproteins of a prudent weight-reducing diet, with or without exercise, in overweight men and women. N Engl J Med. 1991 Aug 15;325(7):461-6. doi: 10.1056/NEJM199108153250703.
PubMed 1852180
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training and Plasma Lipoproteins in Man
- ClinicalTrials.gov ID
- NCT00000519
- Acronym / sponsor ID
- 38
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Hypertension, Myocardial Ischemia, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 1982
- First posted
- 28 Oct 1999 (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.
To determine the effects in moderately obese subjects of weight loss by combined dieting and exercise training on risk factors for coronary artery disease including lipoprotein lipids, apoproteins and blood pressure.
Detailed description
BACKGROUND:
Evidence appears to be fairly conclusive that obesity has adverse effects on health and longevity when the relative body weight is 40 percent above desirable weight based on insurance industry tables of weights. The close association between obesity, hypertension, hypercholesterolemia, non-insulin dependent diabetes mellitus, an excess of certain cancers and other medical problems makes it imperative that interventions be directed to change the lifestyles and behaviors of individuals who are overweight. The Stanford Weight Control Project (SWCP) trial examined the effects of weight loss on cardiovascular disease risk factors.
The Stanford Weight Control Project (SWCP) randomized 155 overweight, sedentary, non-smoking men, aged 30-59 years, to one of three groups. Fifty-one were assigned to weight loss through dieting, 52 to weight loss through exercise, and 52 to a control, non-intervention group. Follow-up continued through July 1989.
DESIGN NARRATIVE:
Subjects were randomized to a control group, a hypocaloric National Cholesterol Education Program (NCEP) diet, or to a hypocaloric NCEP diet with exercise. One hundred nineteen of the men and 112 of the women returned for testing after one year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 25 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| diet, reducing | Behavioural | – |
| exercise | Behavioural | – |
| diet, fat-restricted | Behavioural | – |
Primary outcome
Not reported in the source record.
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 26 Jun 2013.
- Background: PubMed 3598024Camargo CA Jr, Vranizan KM, Dreon DM, Frey-Hewitt B, Wood PD. Alcohol, calorie intake, and adiposity in overweight men. J Am Coll Nutr. 1987 Jun;6(3):271-8. doi: 10.1080/07315724.1987.10720189.
- BackgroundStefanick ML, Frey-Hewitt B, Hoover CA, et al: The Effect of Active Weight Loss Achieved by Dieting Versus Exercise on Postheparin Hepatic and Lipoprotein Lipase Activity. In: Human Obesity. Wurtman RJ and Wurtman JJ, (Eds.), New York, The New York Academy of Sciences, 338-339, 1987.
- BackgroundStefanick ML, Terry RB, Haskell WL, et al: Relationships of Changes in Postheparin Hepatic and Lipoprotein Lipase Activity to HDL-Cholesterol Changes Following Weight Loss Achieved by Dieting Versus Exercise. In: Cardiovascular Disease. Molecular and Cellular Mechanisms, Prevention and Treatment. Gallo LL, (Ed), New York, Plenum Press, 61-68, 1987.
- Background: PubMed 3586249Williams PT, Fortmann SP, Terry RB, Garay SC, Vranizan KM, Ellsworth N, Wood PD. Associations of dietary fat, regional adiposity, and blood pressure in men. JAMA. 1987 Jun 19;257(23):3251-6.
- Background: PubMed 3376914Dreon DM, Frey-Hewitt B, Ellsworth N, Williams PT, Terry RB, Wood PD. Dietary fat:carbohydrate ratio and obesity in middle-aged men. Am J Clin Nutr. 1988 Jun;47(6):995-1000. doi: 10.1093/ajcn/47.6.995.
- Background: PubMed 3381757Fortmann SP, Haskell WL, Wood PD. Effects of weight loss on clinic and ambulatory blood pressure in normotensive men. Am J Cardiol. 1988 Jul 1;62(1):89-93. doi: 10.1016/0002-9149(88)91370-7.
- BackgroundHaskell WL, Stefanick ML, Superko HR: Influence of Exercise on Plasma Lipids and Lipoproteins. In: Exercise, Nutrition, and Energy Metabolism. Horton ES and Terjung RL, (Eds.), New York, Macmillan, 213-227, 1988.
- Background: PubMed 3348757Krauss RM, Williams PT, Lindgren FT, Wood PD. Coordinate changes in levels of human serum low and high density lipoprotein subclasses in healthy men. Arteriosclerosis. 1988 Mar-Apr;8(2):155-62. doi: 10.1161/01.atv.8.2.155.
- Background: PubMed 2846672Kris-Etherton PM, Krummel D, Russell ME, Dreon D, Mackey S, Borchers J, Wood PD. The effect of diet on plasma lipids, lipoproteins, and coronary heart disease. J Am Diet Assoc. 1988 Nov;88(11):1373-400.
- Background: PubMed 3173455Wood PD, Stefanick ML, Dreon DM, Frey-Hewitt B, Garay SC, Williams PT, Superko HR, Fortmann SP, Albers JJ, Vranizan KM, et al. Changes in plasma lipids and lipoproteins in overweight men during weight loss through dieting as compared with exercise. N Engl J Med. 1988 Nov 3;319(18):1173-9. doi: 10.1056/NEJM198811033191801.
- Background: PubMed 2909551Terry RB, Wood PD, Haskell WL, Stefanick ML, Krauss RM. Regional adiposity patterns in relation to lipids, lipoprotein cholesterol, and lipoprotein subfraction mass in men. J Clin Endocrinol Metab. 1989 Jan;68(1):191-9. doi: 10.1210/jcem-68-1-191.
- BackgroundWood PD: Effects of Habitual Exercise on Lipoprotein Metabolism. In: Biological Effects of Physical Activity. Williams RS, Wallace AG, (Eds.), Champaign, IL, Human Kinetics Books, 45-54, 1989.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing diet, reducing, exercise and diet, fat-restricted in people with Cardiovascular Diseases and Coronary Disease, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000519, which also lists 15 linked publications.
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 26 Jun 2013.