Cardiovascular Outcomes Of Diet Counseling

Obesity Clinical Trial

Official title:

Long-term Adherence and Cardiovascular Outcomes of a Randomized Controlled Trial of Medium-intensity Minimally-directive Counseling for Different Diets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324545
• Other study ID #: 2000-1-1
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2000
• Est. completion date: December 31, 2002

Study information

• Verified date: July 2020
• Source: The Camelot Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

(1) What effect does behavioral counseling for vegan, for low to moderate fat, and for lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled, maintain their modified behaviors after they have completed their diet program? (4) How does targeting different diets affect secondary indices associated with heart disease such as weight, lipid, inflammatory, and thrombotic factors?

Description:

Given the current epidemic of overweight and obesity on a global scale ("globesity") and the consequent world public health objective of reducing that obesity, it is evident as a practical matter that, the main line of attack must be through diet. The public health objective and the lack of information regarding the long-term public health effects of alternative weight-loss diets motivated this comparative study of the three major types of weight-loss diets and their long term effects on coronary blood flow. Secondary endpoints are inflammatory and other variables associated with heart disease and obesity.

Specifically we asked: (1) What effect does behavioral counseling for vegan, for low to moderate fat, and for lowered carbohydrate diets have on coronary blood flow? (2) What are the effects of different diet protocols when caloric intake and exercise are equalized? (3) Do people, so counseled, maintain their modified behaviors after they have completed their diet program? (4) How does targeting different diets affect secondary indices associated with heart disease such as weight, lipid, inflammatory, and thrombotic factors?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2002
• Est. primary completion date: December 31, 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 59 Years

Eligibility

Inclusion criteria: BMI greater than 30,

Exclusion criteria: pre-existing co-morbid diseases (documented heart disease, diabetes mellitus, cancer, hypertension, hepatic, renal or gastrointestinal disease), pregnancy or plans for pregnancy. Participants could not be smokers (cigarettes, cigars, pipes or chewing tobacco), take medications (prescription or over the counter medications with the exception of antibiotics), nor take vitamin or mineral supplements. Additionally, they could not currently be on a diet or have been on one during the last 6 months, or have food allergies that would influence food choices.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Obesity

Intervention

Behavioral:
• Medium-intensity Minimally-directive Counseling

Locations

Country	Name	City	State
United States	Keith Block	Chicago	Illinois
United States	Richard M. Fleming, MD	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
The Camelot Foundation	GM Harrington, PhD

Country where clinical trial is conducted

United States, 

References & Publications (14)

Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. — View Citation

Bandura, A. (1986). Social foundations of thought and action: A social cognitive theory. xiii, 617.

Bandura, A. (1997). Self-efficacy: The exercise of control. ix, 604.

Barnard RJ. Effects of life-style modification on serum lipids. Arch Intern Med. 1991 Jul;151(7):1389-94. — View Citation

Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996 Aug 28;276(8):637-9. — View Citation

Cantwell MM, Millen AE, Carroll R, Mittl BL, Hermansen S, Brinton LA, Potischman N. A debriefing session with a nutritionist can improve dietary assessment using food diaries. J Nutr. 2006 Feb;136(2):440-5. — View Citation

Dansinger ML, Gleason JA, Griffith JL, Selker HP, Schaefer EJ. Comparison of the Atkins, Ornish, Weight Watchers, and Zone diets for weight loss and heart disease risk reduction: a randomized trial. JAMA. 2005 Jan 5;293(1):43-53. — View Citation

DAVIS CM. Self regulation of diet in childhood. Health Educ J. 1947 Jan;5:37-40. — View Citation

Fleming RM, Ketchum K, Fleming DM, Gaede R. Assessing the independent effect of dietary counseling and hypolipidemic medications on serum lipids. Angiology. 1996 Sep;47(9):831-40. — View Citation

Fleming RM, Ketchum K, Fleming DM, Gaede R. Treating hyperlipidemia in the elderly. Angiology. 1995 Dec;46(12):1075-83. — View Citation

Fleming RM. Reversing heart disease in the new millennium--the Fleming unified theory. Angiology. 2000 Aug;51(8):617-29. — View Citation

Fleming RM. The effect of high-, moderate-, and low-fat diets on weight loss and cardiovascular disease risk factors. Prev Cardiol. 2002 Summer;5(3):110-8. Erratum in: Prev Cardiol 2002 Fall;5(4):203. — View Citation

Fleming RM. The effect of high-protein diets on coronary blood flow. Angiology. 2000 Oct;51(10):817-26. — View Citation

Fleming, R. M. (1999). The pathogenesis of vascular disease. In J. Chang (Ed.), The Textbook of Angiology (pp. 787-798). New York: Springer-Verlag.

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	coronary blood flow
Secondary	weight
Secondary	BMI
Secondary	LDLc
Secondary	Total Cholesterol
Secondary	HDLc
Secondary	Triglycerides
Secondary	Homocysteine
Secondary	Fibrinogen
Secondary	Lipoprotein (a)
Secondary	VLDLc
Secondary	TC/HDL
Secondary	TG/HDL (Insulin Resistance)
Secondary	CRP
Secondary	IL-6
Secondary	respiratory quotient