NCT01249989

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

3.3 years

First QC Date

November 23, 2010

Last Update Submit

June 8, 2017

Conditions

Health Behavior

Keywords

Physical ActivitySedentary LifestyleDietHealth Behavior

Outcome Measures

Primary Outcomes (6)

  • Change in Fruit/Vegetable Serving Intake

    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

    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)

    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)

    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

    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

    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 Outcomes (6)

  • Change in Blood Pressure (mmHg)

    3 and 9-months

  • Change in Lipids

    3 and 9-months

  • Change in Insulin (mg/dL)

    3 and 9-months

  • Change in Weight (kg)

    3 and 9-months

  • Change in Waist circumference (cm)

    3 and 9-months

  • +1 more secondary outcomes

Study Arms (3)

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.

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.

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.

Behavioral: Stress Management

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.

Sequential MBC Condition
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.

Simultaneous MBC Condition
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.

Stress Management Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University-Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

  • 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.

    PMID: 25625810BACKGROUND

  • Hibler 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.

    PMID: 31506096DERIVED

  • Spring 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.

    PMID: 29921561DERIVED

MeSH Terms

Conditions

Health BehaviorMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Bonnie Spring, PhD, ABPP

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 23, 2010

First Posted

November 30, 2010

Study Start

November 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

June 12, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)