An interventional study of Increase healthy activity and increase healthy eating and Decrease unhealthy activity and increase healthy eating in Cardiovascular Diseases and Heart Diseases, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-04-04.
Sponsored by Northwestern University · Not applicable, Interventional, and Prevention
The purpose of this study is to examine the impact of diet and exercise on an individual's health.
BACKGROUND:
The majority of adult Americans consume a high saturated fat diet, have a low fruit and vegetable (F/V) intake, and lead a sedentary lifestyle. This unhealthy lifestyle heightens their risk for cardiovascular disease and cancer. Improving diet and activity can reduce risk, but the best prescription to promote a healthier diet and a more active lifestyle remains unknown. This study will randomly assign participants to 4 groups, which will include all combinations of increasing healthy eating and activity and decreasing unhealthy eating and activity. The Familiarity Hypothesis predicts that the most familiar dieting prescription (decrease fat, increase physical activity) will maximize healthy behavior change. The Optimal Substitution Hypothesis, based on Behavioral Economic Theory, predicts that increasing F/V intake while decreasing sedentary behavior will surpass alternative methods by maximizing behavioral substitution of healthful eating and activity for unhealthful eating and activity. The Low Inhibitory Demand Hypothesis, based on Self-Control Theory, predicts that increasing F/Vs while increasing physical activity will be most successful because this prescription places the fewest demands on self-control resources.
DESIGN NARRATIVE:
The study will randomize 200 sedentary community-dwelling adults with a suboptimal diet to 1 of 4 groups including: 1) increase healthy eating and activity; 2) decrease unhealthy eating and activity; 3) increase healthy eating and decrease unhealthy activity; and 4) decrease unhealthy eating and increase healthy physical activity. Subjects will self-monitor diet, physical activity, and mood via PDAs during a 2-week baseline period, a 3-week prescription period (when payment is contingent upon changing eating and activity simultaneously to targeted standards), and a 4-month maintenance period. Targeted and collateral diet and activity changes will be measured by self report, accelerometer, and grocery receipts. Bogus pipeline urinary testing will encourage adherence. Laboratory testing will measure behavioral choices, craving, and attentional allocation to restricted foods and activities in a permissive context in order to shed light on behavioral and psychological processes that mediate healthy lifestyle change. Findings will help to fill an important gap in clinical knowledge about how to optimize healthy simultaneous change in diet and activity among adults.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 204 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
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Exclusion Criteria:
Increase healthy eating and increase healthy activity
Behavioral: Increase healthy activity and increase healthy eating
Increase healthy eating and decrease unhealthy activity
Behavioral: Decrease unhealthy activity and increase healthy eating
Decrease unhealthy eating and increase healthy activity
Behavioral: Increase physical activity and decrease unhealthy eating
Decrease unhealthy activity and decrease unhealthy eating
Behavioral: Decrease sedentary activity and decrease unhealthy eating
Increase participants to 60 minutes of activity per day and 5 fruits and vegetables per day over a 3 week prescription phase
Decrease sedentary activity by 90 minutes per day and increase fruits and vegetables to 5 servings per day over the course of a 3 week prescription phase
Increase physical activity up to 60 minutes per day and decrease saturated fat to an average of 8% per day over the course of a 3 week prescription phase
Decrease sedentary activity by 90 minutes per day and decrease saturated fat to and average of 8% per day over the course of a 3 week prescription phase
Daily diet and activity (measured at Week 1 and 3, and Month 1, 2, 3, 4, 5, and 6)
Time frame: 6 months
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Northwestern University