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临床试验/NCT01249989
NCT01249989已完成不适用

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

Northwestern University2 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
212
试验地点
2
主要终点
Change in Dietary Intake

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Change in Dietary Intake

时间窗: 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.

Change in Fruit/Vegetable Serving Intake

时间窗: 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

时间窗: 3, 6, and 9-months

Change from baseline in saturated fat intake (assessed by % of daily calories from fat) at 3, 6, 9-months.

Healthy Diet and Activity Improvement

时间窗: 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

Change in Sedentary Leisure Screen Time (minutes/week)

时间窗: 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)

时间窗: 3, 6, and 9-months

Change from baseline in minutes per week of physical activity measured by accelerometer at 3, 6, and 9-months.

次要结局

  • Change in Lipids(3 and 9-months)
  • Change in Insulin (mg/dL)(3 and 9-months)
  • Change in Blood Pressure (mmHg)(3 and 9-months)
  • Change in Quality of Life(3 and 9-months)
  • Change in Weight (kg)(3 and 9-months)
  • Change in Waist circumference (cm)(3 and 9-months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bonnie Spring

Professor

Northwestern University

研究点 (2)

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