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| Tracking Information | |||||
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| First Received Date ICMJE | May 25, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | May 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00005747 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Promoting Long Term Dietary Change to Reduce CVD Risk | ||||
| Official Title ICMJE | |||||
| Brief Summary | To test the long-term effectiveness of a new behavioral strategy, taste-based goal setting, that relied 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. |
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| Detailed Description | 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 was a randomized controlled experiment in which 186 men and women age 25-74 years who had an intake of saturated fat of more than 10 percent were 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 followed the National Cholesterol Education Program (NCEP) Step I goals. Intake of saturated fat was measured using 3-day unannounced 24-hour telephone dietary recalls at baseline, post-intervention (eight weeks), and 12 months from baseline. Study participants were recruited from local communities and represented the level of ethnic diversity in the target population. The primary aim of this study was to determine whether the addition of a taste-based goal setting strategy to a standard low-fat intervention resulted 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 were to examine the long-term effects of taste-based goal setting on four additional sets of outcomes of major interest. First, what were 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 were 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 were 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 were the long-term effects on psychological outcomes (i.e., food preoccupation, willingness to try new foods, and restrained eating)? |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History, Longitudinal | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | April 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Male | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00005747 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 5054 | ||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Verification Date | August 2004 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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