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Exercise Training and Plasma Lipoproteins in Man

Primary Purpose

Cardiovascular Diseases, Coronary Disease, Heart Diseases

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
diet, reducing
exercise
diet, fat-restricted
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

25 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    June 25, 2013
    Sponsor
    Stanford University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000519
    Brief Title
    Exercise Training and Plasma Lipoproteins in Man
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1982 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Coronary Disease, Heart Diseases, Hypertension, Myocardial Ischemia, Obesity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    diet, reducing
    Intervention Type
    Behavioral
    Intervention Name(s)
    exercise
    Intervention Type
    Behavioral
    Intervention Name(s)
    diet, fat-restricted

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    49 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    3598024
    Citation
    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.
    Results Reference
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    Citation
    Stefanick 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.
    Results Reference
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    Citation
    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.
    Results Reference
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    PubMed Identifier
    3586249
    Citation
    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.
    Results Reference
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    PubMed Identifier
    3376914
    Citation
    Dreon 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.
    Results Reference
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    PubMed Identifier
    3381757
    Citation
    Fortmann 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.
    Results Reference
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    Citation
    Haskell 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.
    Results Reference
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    PubMed Identifier
    3348757
    Citation
    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.
    Results Reference
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    PubMed Identifier
    2846672
    Citation
    Kris-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.
    Results Reference
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    PubMed Identifier
    3173455
    Citation
    Wood 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.
    Results Reference
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    PubMed Identifier
    2909551
    Citation
    Terry 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.
    Results Reference
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    Citation
    Wood 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.
    Results Reference
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    PubMed Identifier
    2596943
    Citation
    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.
    Results Reference
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    PubMed Identifier
    2361810
    Citation
    Frey-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.
    Results Reference
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    PubMed Identifier
    1852180
    Citation
    Wood 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.
    Results Reference
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    Exercise Training and Plasma Lipoproteins in Man

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