Clinical trial NCT01249989: Make Better Choices
Official title: Make Better Choices (MBC) - Multiple Behavior Change in Diet and Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Physical Activity
Sedentary Lifestyle
Diet
Health Behavior
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-11-30
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Fruit/Vegetable Serving Intake
timeFrame: 3, 6, and 9 months
measure: Change in Saturated Fat (% of daily calories from fat) Intake
timeFrame: 3, 6, and 9-months
measure: Change in Sedentary Leisure Screen Time (minutes/week)
timeFrame: 3, 6, and 9-months
measure: Change in Physical Activity (minutes/week)
timeFrame: 3, 6, and 9-months
measure: Change in Dietary Intake
timeFrame: 3 and 9-months
measure: Healthy Diet and Activity Improvement
timeFrame: 3, 6, and 9 months
Secondary outcomes:
measure: Change in Blood Pressure (mmHg)
timeFrame: 3 and 9-months
measure: Change in Lipids
timeFrame: 3 and 9-months
measure: Change in Insulin (mg/dL)
timeFrame: 3 and 9-months
measure: Change in Weight (kg)
timeFrame: 3 and 9-months
measure: Change in Waist circumference (cm)
timeFrame: 3 and 9-months
measure: Change in Quality of Life
timeFrame: 3 and 9-months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University-Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Bonnie Spring, PhD, ABPP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.