Cardiovascular Diseases Clinical Trial
Official title:
Multiple Behavior Change in Diet and Activity
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
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