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

Abstract

BackgroundSuboptimal 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/DesignAdults (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.DiscussionThe 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 RegistrationClinical Trials Gov. Identifier NCT00113672

Mechanisms of change in diet and activity in the Make Better Choices 1 trial.

“…During maintenance, participants were encouraged to use the mobile device to maintain behavior changes, but were not financially incentivized to do so. More detailed descriptions of the parent study design (Spring et al, 2010) and results are presented elsewhere (Spring et al 2012). The Northwestern University and University of Illinois at Chicago Institutional Review Boards approved the study procedures.…”

Lifestyle intervention effects on the frequency and duration of daily moderate–vigorous physical activity and leisure screen time.

“…An illustrative intervention derived from these findings to increase physical activity and reduce leisure screen time was the multiple-behavior change Make Better Choices intervention (Spring et al, 2010). This trial incorporated features such as progressive goal setting, self-monitoring with feedback, and behavior coaching.…”

The South Asian Heart Lifestyle Intervention (SAHELI) study to improve cardiovascular risk factors in a community setting: Design and methods

“…SAHELI combines standard behavioral strategies that have been shown to improve the effectiveness of lifestyle interventions [43–47] and culturally-targeted strategies [30], developed from our formative work [24, 28, 29] to help South Asians adopt healthy lifestyles and reduce CVD risk (Table 3). The culturally-targeted strategies will include implementing the intervention in a CBO-setting that is trusted and provides social services to immigrants, incorporating South Asians’ EMs of CHD, culturally-salient activities such as yoga, increasing social support through group activities and heart health melas for participants and their families, and a focus on health behavior change within the socio-cultural context of South Asian immigrants.…”