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Home > "P" Clinical Trials Conditions > Promoting Long Term Dietary Change to Reduce CVD Risk  Promoting Long Term Dietary Change to Reduce CVD Risk
Promoting Long Term Dietary Change to Reduce CVD Risk
For Condition: Coronary Heart Disease Risk Reduction,Cardiovascular Diseases,Heart Diseases
Status: No longer recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To test the long-term effectiveness of a new behavioral strategy, taste-based goal setting, that relies on the role of taste and eating favorite high-fat foods in moderation to minimize feelings of deprivation and dissatisfaction, and, thus, increase the likelihood of long-term dietary change.
Details: BACKGROUND: Because long-term reductions in saturated fat are crucial for cardiovascular and overall health, national experts in the areas of cardiovascular disease, nutrition, and obesity have identified the development of new behavioral strategies that promote long-term dietary change as a research area of critical importance. DESIGN NARRATIVE: The study design is a randomized controlled experiment in which 186 men and women age 25-74 years who have an intake of saturated fat of more than 10 percent are randomized to one of three conditions: (1) a taste-based goal setting + standard low-fat dietary intervention, (2) a standard low-fat dietary intervention alone, or (3) an assessment-only control condition. Both active interventions follow the National Cholesterol Education Program (NCEP) Step I goals. Intake of saturated fat is measured using 3-day unannounced 24-hour telephone dietary recalls at baseline, post-intervention (eight weeks), and 12 months from baseline. Study participants are recruited from local communities and represent the level of ethnic diversity in the target population. The primary aim of this study is to determine whether the addition of a taste-based goal setting strategy to a standard low-fat intervention results in better maintenance of reductions in saturated fat at 12 months than either a standard low-fat intervention alone or an assessment-only control condition. The secondary aims of this study are to examine the long-term effects of taste-based goal setting on four additional sets of outcomes of major interest. First, what are the long-term effects of taste-based goal setting on the hypothesized psychological mediators (i.e., attitudes toward perceived deprivation, the taste of low-fat foods, and eating high-fat foods in moderation)? Second, what are the long-term effects of taste-based goal setting on nutritional adequacy, such as sufficient intake of important food groups needed for overall health (e.g., fruits and vegetables) and dietary nutrients other than fats and cholesterol (e.g., intake of fiber, vitamins, and minerals)? Third, what are the long-term effects on physiological outcomes related to risk of cardiovascular disease (i.e., low density lipoprotein [LDL] plasma cholesterol, blood pressure, and body mass index)? Fourth, what are the long-term effects on psychological outcomes (i.e., food preoccupation, willingness to try new foods, and restrained eating)?
Eligibility:
Study Type: Observational, Natural History, Longitudinal
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelaKiernan, , Stanford University
Additional Information:
Study ID Numbers: 5054;
Study Start Date: May 1998
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005747
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Promoting Long Term Dietary Change to Reduce CVD Risk
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