Make Better Choices Study (MBC)

Northwestern University

Status: Completed

Conditions: Cardiovascular Diseases; Heart Diseases

Treatments: Behavioral: Increase physical activity and decrease unhealthy eating; Behavioral: Increase healthy activity and increase healthy eating; Behavioral: Decrease unhealthy activity and increase healthy eating; Behavioral: Decrease sedentary activity and decrease unhealthy eating

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00113672

R01HL075451 (U.S. NIH Grant/Contract)

182

Details and patient eligibility

About

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

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sedentary community dwelling adults with a suboptimal diet
• Motivated to make changes in diet and activity level

Exclusion criteria

• Few exclusion criteria will be implemented in order to enhance generalizability
• For safety, participants with unstable medical conditions (uncontrolled hypertension, diabetes, recent myocardial infarction) will be excluded. Those with stable medical conditions will require physician approval to participate but will not be excluded because the prescribed changes in diet and activity match healthy, attainable guidelines for all Americans.
• Cannot read the study questionnaires
• Committed to following an incompatible dietary regimen
• Pregnant, trying to get pregnant, or breastfeeding
• People with anorexia, bulimia, or report active suicidal ideation will not be enrolled because they might practice overly severe dietary restrictions
• Binge eating disorder
• Current substance abuse or dependence, other than nicotine dependence will be excluded because of concern about their ability to maintain accurate records of intake and activity. Smokers will be accepted and during recreational laboratory sessions will be able to smoke cigarettes in an adjoining room that is used as a smoking laboratory.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

204 participants in 4 patient groups

A

Experimental group

Description:

Increase healthy eating and increase healthy activity

Treatment:

Behavioral: Increase healthy activity and increase healthy eating

B

Experimental group

Description:

Increase healthy eating and decrease unhealthy activity

Treatment:

Behavioral: Decrease unhealthy activity and increase healthy eating

C

Experimental group

Description:

Decrease unhealthy eating and increase healthy activity

Treatment:

Behavioral: Increase physical activity and decrease unhealthy eating

D

Experimental group

Description:

Decrease unhealthy activity and decrease unhealthy eating

Treatment:

Behavioral: Decrease sedentary activity and decrease unhealthy eating