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Open Access Highly Accessed Study protocol

Make Better Choices (MBC): Study design of a randomized controlled trial testing optimal technology-supported change in multiple diet and physical activity risk behaviors

Bonnie Spring12*, Kristin Schneider2, HG McFadden1, Jocelyn Vaughn1, Andrea T Kozak12, Malaina Smith12, Arlen C Moller1, Leonard Epstein3, Stephanie W Russell1, Andrew DeMott12 and Donald Hedeker4

Author Affiliations

1 Department of Preventive Medicine, Northwestern University, Chicago, Illinois, USA

2 Department of Psychology, University of Illinois - Chicago, Chicago, Illinois, USA

3 Department of Social and Preventive Medicine, University of Buffalo, Buffalo, New York, USA

4 Department of Epidemiology and Biostatistics, University of Illinois - Chicago, Chicago, Illinois, USA

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BMC Public Health 2010, 10:586  doi:10.1186/1471-2458-10-586

Published: 29 September 2010

Abstract

Background

Suboptimal diet and physical inactivity are prevalent, co-occurring chronic disease risk factors, yet little is known about how to maximize multiple risk behavior change. Make Better Choices, a randomized controlled trial, tests competing hypotheses about the optimal way to promote healthy change in four bundled risk behaviors: high saturated fat intake, low fruit and vegetable intake, low physical activity, and high sedentary leisure screen time. The study aim is to determine which combination of two behavior change goals - one dietary, one activity - yields greatest overall healthy lifestyle change.

Methods/Design

Adults (n = 200) with poor quality diet and sedentary lifestyle will be recruited and screened for study eligibility. Participants will be trained to record their diet and activities onto a personal data assistant, and use it to complete two weeks of baseline. Those who continue to show all four risk behaviors after baseline recording will be randomized to one of four behavior change prescriptions: 1) increase fruits and vegetables and increase physical activity, 2) decrease saturated fat and increase physical activity, 3) increase fruits and vegetable and decrease saturated fat, or 4) decrease saturated fat and decrease sedentary activity. They will use decision support feedback on the personal digital assistant and receive counseling from a coach to alter their diet and activity during a 3-week prescription period when payment is contingent upon meeting behavior change goals. They will continue recording on an intermittent schedule during a 4.5-month maintenance period when payment is not contingent upon goal attainment. The primary outcome is overall healthy lifestyle change, aggregated across all four risk behaviors.

Discussion

The Make Better Choices trial tests a disseminable lifestyle intervention supported by handheld technology. Findings will fill a gap in knowledge about optimal goal prescription to facilitate simultaneous diet and activity change. Results will shed light on which goal prescription maximizes healthful lifestyle change.

Trial Registration

Clinical Trials Gov. Identifier NCT00113672