Health BehaviorMBC2NCT01249989
Make Better Choices
A study testing Sequential MBC Condition, Simultaneous MBC Condition and Stress Management in people with Health Behavior, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Sequential MBC Condition, Simultaneous MBC Condition and Stress Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University-Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: 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.
Read the 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.
- Conditions
- Health Behavior
- Being tested
- Sequential MBC Condition, Simultaneous MBC Condition, Stress Management
- Keywords
- Physical Activity, Sedentary Lifestyle, Diet, Health Behavior
- Medical subject headings
- Health Behavior, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential MBC ConditionBehavioural
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 ConditionBehavioural
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 ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sequential MBC Condition | Experimental | 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. Receives: Behavioral: Sequential MBC Condition |
| Simultaneous MBC Condition | Experimental | 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. Receives: Behavioral: Simultaneous MBC Condition |
| Stress Management Control | Active comparator | 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. Receives: Behavioral: Stress Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fruit/Vegetable Serving Intake
Change from baseline in standard fruit/vegetable serving intake measured at 3, 6, and 9 months.
Measured: 3, 6, and 9 months
Change in Saturated Fat (% of daily calories from fat) Intake
Change from baseline in saturated fat intake (assessed by % of daily calories from fat) at 3, 6, 9-months.
Measured: 3, 6, and 9-months
Change in Sedentary Leisure Screen Time (minutes/week)
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.
Measured: 3, 6, and 9-months
Change in Physical Activity (minutes/week)
Change from baseline in minutes per week of physical activity measured by accelerometer at 3, 6, and 9-months.
Measured: 3, 6, and 9-months
Change in Dietary Intake
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.
Measured: 3 and 9-months
Healthy Diet and Activity Improvement
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
Measured: 3, 6, and 9 months
Secondary outcomes (6)
Change in Blood Pressure (mmHg)
Change from baseline in blood pressure measured in mmHg according to the CARDIA protocol.
Measured: 3 and 9-months
Change in Lipids
Change from baseline in lipids (total cholesterol, triglycerides, HDL-C, calculated LDL-C) assayed following antecubital venipuncture
Measured: 3 and 9-months
Change in Insulin (mg/dL)
Change from baseline in insulin measured in mg/dL via immunoassay following antecubital venipuncture at 3 and 9-months.
Measured: 3 and 9-months
Change in Weight (kg)
Change from baseline in body weight in kg measured using calibrated beam balance scale at 3 and 9-months.
Measured: 3 and 9-months
Change in Waist circumference (cm)
Change from baseline in waist circumference measured in cm (repeated twice, then averaged) at 3 and 9-months.
Measured: 3 and 9-months
Change in Quality of Life
Change from baseline in quality of life measured by the SF-36 self-report questionnaire at 3 and 9-months.
Measured: 3 and 9-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startNov 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Bonnie Spring, Northwestern University
- Investigators
- Bonnie Spring, PhD, ABPP, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249989
- Sponsor's protocol ID
- R01HL075451
- Other IDs
- R01HL075451
- Acronym
- MBC2
- Status last verified
- Jun 2017
- First submitted
- 23 Nov 2010
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pellegrini CA, Steglitz J, Johnston W, Warnick J, Adams T, McFadden HG, Siddique J, Hedeker D, Spring B. Design and protocol of a randomized multiple behavior change trial: Make Better Choices 2 (MBC2). Contemp Clin Trials. 2015 Mar;41:85-92. doi: 10.1016/j.cct.2015.01.009. Epub 2015 Jan 24.
PubMed 25625810Battalio SL, Spring B, Wilson E, Hedeker D, Pfammatter AF. Behavior change intervention targeting physical activity and diet improves stress and sleep. PLoS One. 2026 Mar 2;21(3):e0343397. doi: 10.1371/journal.pone.0343397. eCollection 2026.
PubMed 41770781Hibler E, Huang L, Andrade J, Spring B. Impact of a diet and activity health promotion intervention on regional patterns of DNA methylation. Clin Epigenetics. 2019 Sep 11;11(1):133. doi: 10.1186/s13148-019-0707-0.
PubMed 31506096Spring B, Pellegrini C, McFadden HG, Pfammatter AF, Stump TK, Siddique J, King AC, Hedeker D. Multicomponent mHealth Intervention for Large, Sustained Change in Multiple Diet and Activity Risk Behaviors: The Make Better Choices 2 Randomized Controlled Trial. J Med Internet Res. 2018 Jun 19;20(6):e10528. doi: 10.2196/10528.
PubMed 29921561
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Make Better Choices (MBC) - Multiple Behavior Change in Diet and Activity
- ClinicalTrials.gov ID
- NCT01249989
- Acronym / sponsor ID
- MBC2 / R01HL075451
- Conditions
- Health Behavior
- Keywords
- Physical Activity, Sedentary Lifestyle, Diet, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequential MBC Condition | Experimental | Behavioral: Sequential MBC ConditionParticipants 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 Condition | Experimental | Behavioral: Simultaneous MBC ConditionParticipants 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. |
| Stress Management Control | Active comparator | Behavioral: Stress ManagementParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sequential MBC ConditionParticipants 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. | Behavioural | Sequential MBC Condition |
| Simultaneous MBC ConditionSimultaneous 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. | Behavioural | Simultaneous MBC Condition |
| Stress ManagementParticipants 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. | Behavioural | Stress Management Control |
Primary outcome
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.
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.
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.
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.
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.
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
6 secondary outcomes
Change in Blood Pressure (mmHg)
Time frame: 3 and 9-months
Change in Lipids
Time frame: 3 and 9-months
Change in Insulin (mg/dL)
Time frame: 3 and 9-months
Change in Weight (kg)
Time frame: 3 and 9-months
Change in Waist circumference (cm)
Time frame: 3 and 9-months
Change in Quality of Life
Time frame: 3 and 9-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Background: PubMed 25625810Pellegrini CA, Steglitz J, Johnston W, Warnick J, Adams T, McFadden HG, Siddique J, Hedeker D, Spring B. Design and protocol of a randomized multiple behavior change trial: Make Better Choices 2 (MBC2). Contemp Clin Trials. 2015 Mar;41:85-92. doi: 10.1016/j.cct.2015.01.009. Epub 2015 Jan 24.
- Derived from this study: PubMed 41770781Battalio SL, Spring B, Wilson E, Hedeker D, Pfammatter AF. Behavior change intervention targeting physical activity and diet improves stress and sleep. PLoS One. 2026 Mar 2;21(3):e0343397. doi: 10.1371/journal.pone.0343397. eCollection 2026.
- Derived from this study: PubMed 31506096Hibler E, Huang L, Andrade J, Spring B. Impact of a diet and activity health promotion intervention on regional patterns of DNA methylation. Clin Epigenetics. 2019 Sep 11;11(1):133. doi: 10.1186/s13148-019-0707-0.
- Derived from this study: PubMed 29921561Spring B, Pellegrini C, McFadden HG, Pfammatter AF, Stump TK, Siddique J, King AC, Hedeker D. Multicomponent mHealth Intervention for Large, Sustained Change in Multiple Diet and Activity Risk Behaviors: The Make Better Choices 2 Randomized Controlled Trial. J Med Internet Res. 2018 Jun 19;20(6):e10528. doi: 10.2196/10528.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie Spring, PhD, ABPP principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential MBC Condition, Simultaneous MBC Condition and Stress Management in people with Health Behavior, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fruit/Vegetable Serving Intake (time frame: 3, 6, and 9 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01249989, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.