CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 212 enrolled
Drug / intervention
Sequential MBC Condition +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01249989
NCT01249989N/ACompleted

Make Better Choices (MBC) - Multiple Behavior Change in Diet and Activity

Northwestern University·interventional·Posted Nov 30, 2010·Updated Jun 12, 2017

In Brief

A clinical study evaluating Sequential MBC Condition, Simultaneous MBC Condition, and 1 other intervention for Health Behavior. Completed, enrolled 212 participants across 1 site.

Detailed Summary

The average adult has a poor quality diet and sedentary lifestyle, but the best way to produce sustained healthy change remains unknown. The MBC2 intervention uses handheld technology to help individuals monitor and transmit information about their eating and activity remotely to a behavior coach. The proposed trial tests whether MBC2 intervention improves diet and activity more than a stress management control condition, and whether changing multiple health behaviors is best achieved by changing them all at the same time, or one after another.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealth Behavior
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2010
Enrollment StartNov 1, 2011
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 15.6 years ago

Interventions

Sequential MBC Conditionbehavioral

Participants in the sequential condition will increase F/V consumption and decrease Sed behavior (weeks 1-6), then increase physical activity (weeks 7-12). Smartphones are equipped with customized real-time goal thermometers that provide objective feedback on target behaviors (FV, Sed, and PA). At the start of prescription, the FV and Sed goal thermometers are activated. During week 1-2, participants will close 1/3 of the gap between their baseline behaviors and target behaviors. During week 3-4 they will close 2/3 of the gap, and in weeks 5-6 they will achieve 100% of their goals. Participants will maintain these goals for the remainder of the 12-week intervention. At week 7, a real-time PA goal thermometer wirelessly linked to accelerometers will be activated. Similarly, in weeks 7-8 participants will be asked to close 1/3 of the gap between their baseline PA and target, in week 9-10 they will close 2/3 of the gap, and finally they will reach 100% of their PA goal in weeks 11-12.

Simultaneous MBC Conditionbehavioral

Simultaneous MBC condition will target FV+, Sed- and PA+ simultaneously. Participants in the simultaneous condition will wear their accelerometers and enter diet and sedentary activity 5 days/week. All 3 goal thermometers will be activated from the outset of prescription. The goal will be to close 1/3 of the gap between their FV, Sed, and PA statuses and the targets in weeks 1-2, close 2/3 of the gap in weeks 3-4, reach their targets in weeks 5-6, and then maintain target level behavior changes for FV, Sed and PA through week 12.

Stress Managementbehavioral

Participants in the stress management control condition target stress, relaxation and sleep. This will serve as an attentional control condition. During the 12-week prescription period, participants will wear accelerometers, log hours slept, enter real-time information about their relaxation exercises and stress, and monitor 3 goal thermometers (sleep, relaxation, stress) to meet behavioral targets. Similarly, their goal is to close 1/3 of the gap between their baseline stress, sleep, and performance of relaxation exercises and the target criterion in weeks 1-2, close 2/3 of the gap in weeks 3-4, reach their targets in weeks 5-6, and then maintain these behavior changes through week 12.