Make Better Choices (MBC2)

June 8, 2017 updated by: Bonnie Spring, Northwestern University

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Poor quality diet and physical inactivity are the most prevalent, preventable causes of death in the United States. In particular, high saturated fat diet (Fat), low fruit and vegetable intake (FV), low physical activity (PA), and high sedentary leisure screen time (Sed) co-occur and heighten the risks of cardiovascular disease and cancers. The first Make Better Choices (MBC1) experiment contrasted four strategies to promote healthful change across these four risk behaviors. Each intervention targeted two behaviors (one diet, one activity) simultaneously and either increased healthy or decreased unhealthy responding. The intervention targeting increased FV and decreased Sed was most efficacious, yielding unexpectedly sustained improvement in three out of the four risk behaviors (FV, Sed, Fat). The proposed MBC2 trial tests the efficacy of MBC intervention to promote sustained, healthful change in diet and activity at 6 and 12 months, as contrasted with a stress management control condition. MBC2 tests competing hypotheses about the optimal way to increase PA without undermining the maintenance of FV, Sed, and Fat by changing multiple behaviors either sequentially or simultaneously. Furthermore, MBC2 examines mediators and biomarkers of healthy lifestyle change. Community dwelling adults (N=250) with suboptimal diet and inactive lifestyle will be randomized to the following conditions: 1) Sequential MBC (increasing FV intake and decreasing Sed, followed by increasing PA), 2) Simultaneous MBC (increasing FV, decreasing Sed, and increasing PA), or 3) Control (stress management). Participants in all conditions will use Smartphones equipped with customized behavioral decision support tools to self-monitor health behaviors. These handheld devices will be programmed to automatically transmit these data to our study server to be reviewed by a personal behavior coach. Based on theories of self-regulation and habit strength, the Mastery hypothesis predicts superior health behavior change for participants randomized to the sequential condition. It is anticipated that these effects will be mediated by greater habit strength for healthy eating and physical activity. However, based on goal systems theory, the Synergy hypothesis predicts superior health behavior change among participants randomized to the simultaneous condition. It is anticipated that these effects will be mediated by the establishment of superordinate healthy lifestyle goals. The results of the MBC2 trial will assist researchers in understanding the optimal manner in which to facilitate multiple health behavior change in this population. Furthermore, these data will help to identify the mechanisms that underlie healthy change among prevalent risk behaviors. If successful, this trial will also result in an innovative, highly disseminable technology-supported minimal counseling intervention to address the American unhealthy diet and sedentary lifestyle.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University-Feinberg School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must expect to reside in the Chicagoland area for the next 9 months
  • Must be willing to record diet, sedentary activities, and/or stress and sleep and wear an accelerometer for 12 weeks and intermittently thereafter for the next 9-months
  • Must agree to make changes in eating and activity or in sleep and relaxation behaviors

  • Participants must report all of the following on screening questionnaires:

    • Low fiber diet (< 9 FV servings/day)
    • High saturated fat intake (> 8% of daily calories from fat)
    • Less than 150 minutes per week of moderate intensity physical activity per week for the past 3 months (or less than 75 minutes of vigorous intensity activity per week)
    • An average of > 120 minutes/day spent on non-work, non-education related use of the following recreational sedentary pastimes: television, videos/movies, videogames, and computer use

Exclusion Criteria:

  • Unstable medical conditions (e.g., uncontrolled hypertension, diabetes, recent myocardial infarction)
  • Physician approval for those with existing and controlled medication conditions
  • Those that require an assistive device for ambulation
  • > 350 lbs
  • Currently taking weight loss medications
  • Psychiatric hospitalization in past 5 years
  • Those at risk for adverse cardiovascular disease (CVD) events with moderate intensity activity (e.g., CVD symptoms while walking, those scheduled for cardiac stress test within 2 months)
  • Those who cannot read English sufficiently to respond to self-report questionnaires
  • Current or anticipated pregnancy
  • Women who are lactating
  • Current active eating disorders (anorexia, bulimia)
  • Current substance abuse or dependence (other than nicotine)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequential MBC Condition
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.
Behavioral: Sequential MBC Condition
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.
Experimental: Simultaneous MBC Condition
Participants in the simultaneous condition will target FV+, Sed- and PA+ simultaneously. Participants will wear accelerometers and enter diet and sedentary activity 5 days/week on their Smartphone. All 3 goal thermometers will be activated from the outset of prescription (FV, Sed, PA). In week 1-2, participants will close 1/3 of the gap between their baseline FV, Sed, and PA behavior and their goals. In week 3-4 participants will close 2/3 of the gap, and 100% of their goals in weeks 5-6. Participants will maintain their target behaviors for FV, Sed and PA through week 12.
Behavioral: Simultaneous MBC Condition
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.
Active Comparator: Stress Management Control
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.
Behavioral: Stress Management
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Fruit/Vegetable Serving Intake
Time Frame: 3, 6, and 9 months
Change from baseline in standard fruit/vegetable serving intake measured at 3, 6, and 9 months.
3, 6, and 9 months
Change in Saturated Fat (% of daily calories from fat) Intake
Time Frame: 3, 6, and 9-months
Change from baseline in saturated fat intake (assessed by % of daily calories from fat) at 3, 6, 9-months.
3, 6, and 9-months
Change in Sedentary Leisure Screen Time (minutes/week)
Time Frame: 3, 6, and 9-months
Change from baseline in minutes per week of sedentary leisure screen time (e.g., TV watching, recreational computer use) at 3, 6, and 9-months.
3, 6, and 9-months
Change in Physical Activity (minutes/week)
Time Frame: 3, 6, and 9-months
Change from baseline in minutes per week of physical activity measured by accelerometer at 3, 6, and 9-months.
3, 6, and 9-months
Change in Dietary Intake
Time Frame: 3 and 9-months
Change from baseline in dietary consumption (e.g., fruits/vegetables) measured by clinician administered dietary recall (Block Food Frequency Questionnaire) at 3 and 9-months. This standardized measure will be used to validate the self-report data.
3 and 9-months
Healthy Diet and Activity Improvement
Time Frame: 3, 6, and 9 months
Healthy diet and activity improvement standardized to a common z score metric and aggregated across changes in fruit and vegetable intake, saturated fat intake, sedentary leisure screen time, and physical activity
3, 6, and 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Blood Pressure (mmHg)
Time Frame: 3 and 9-months
Change from baseline in blood pressure measured in mmHg according to the CARDIA protocol.
3 and 9-months
Change in Lipids
Time Frame: 3 and 9-months
Change from baseline in lipids (total cholesterol, triglycerides, HDL-C, calculated LDL-C) assayed following antecubital venipuncture
3 and 9-months
Change in Insulin (mg/dL)
Time Frame: 3 and 9-months
Change from baseline in insulin measured in mg/dL via immunoassay following antecubital venipuncture at 3 and 9-months.
3 and 9-months
Change in Weight (kg)
Time Frame: 3 and 9-months
Change from baseline in body weight in kg measured using calibrated beam balance scale at 3 and 9-months.
3 and 9-months
Change in Waist circumference (cm)
Time Frame: 3 and 9-months
Change from baseline in waist circumference measured in cm (repeated twice, then averaged) at 3 and 9-months.
3 and 9-months
Change in Quality of Life
Time Frame: 3 and 9-months
Change from baseline in quality of life measured by the SF-36 self-report questionnaire at 3 and 9-months.
3 and 9-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bonnie Spring, PhD, ABPP, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01HL075451 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Health Behavior

Clinical Trials on Sequential MBC Condition

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings