Make Better Choices Study
Condition: Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to examine the impact of diet and exercise on an individual's
      health.
    

Detailed description: 
      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.
    

Intervention name(s): Increase healthy activity and increase healthy eating; Decrease unhealthy activity and increase healthy eating; Increase physical activity and decrease unhealthy eating; Decrease sedentary activity and decrease unhealthy eating
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention