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临床试验/NCT02752464
NCT02752464已完成不适用

Behavioral Cardiovascular Disease Prevention Using Informatics

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2016年9月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
2
主要终点
Weight-objective measurement

研究概览

简要总结

Overweight/obesity is strongly linked to mortality from multiple chronic diseases, including cardiovascular disease, diabetes, and obesity-related cancers.The successful management of overweight/obesity requires management of nutrition and physical activity over time. For racial/ethnic minority and low-income populations, who face both higher prevalence of obesity and chronic diseases compared to others, interventions promoting behavioral change are a national health priority. From the available range of behavioral change intervention strategies, there is a growing knowledge base that documents the efficacy of peer support interventions for improving self-care, quality of life, and behavioral change. In this study, the investigators will examine the following research question: What is the preliminary efficacy and degree of implementation and acceptability of an intervention approach in which peer counselors provide evidenced-based counseling about nutrition and physical activity behaviors for weight management to public housing residents using a computer-assisted program called CuesWeight?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • Willing to wear an accelerometer
  • 18-65 years old
  • Public housing resident with no plans to move in next 6 months
  • Body mass index ≥25
  • Open to making changes to diet & physical activity habits

排除标准

  • Currently enrolled in a comprehensive weight loss program or a research study whose primary outcome is weight loss
  • Primary language spoken is a language other than Spanish or English
  • Not willing to participate in study protocols, including wearing the accelerometer, not willing to have study staff send text messages

研究组 & 干预措施

Feedback report plus peer counseling

Experimental

Feedback report plus peer counseling Participants receive 12 sessions of behavioral counseling and a brief printed feedback report

干预措施: Counseling (Behavioral)

Feedback report plus peer counseling

Experimental

Feedback report plus peer counseling Participants receive 12 sessions of behavioral counseling and a brief printed feedback report

干预措施: feedback report (Behavioral)

Feedback report

Active Comparator

Feedback report Participants receive a brief printed feedback report

干预措施: feedback report (Behavioral)

结局指标

主要结局

Weight-objective measurement

时间窗: 12 weeks

Weight in pounds will be measured objectively with a digital scale

次要结局

  • Diet, fruits and vegetables, self-reported via questionnaire(12 weeks)
  • Diet, sugar sweetened beverages, self-reported via questionnaire(12 weeks)
  • Diet, fast food, self-reported via questionnaire(12 weeks)
  • Internal motivation, self-reported via questionnaire(12 weeks)
  • Physical activity, objectively measured(12 weeks)
  • Physical activity, self-reported(12 weeks)
  • Self-efficacy for doing physical activity, self-reported via questionnaire(12 weeks)
  • Self-efficacy for eating a healthful diet, self-reported via questionnaire(12 weeks)
  • Social support, self-reported via questionnaire(12 weeks)
  • Feasibility, number of counseling sessions completed(12 weeks)
  • Feasibility, acceptability of intervention(12 weeks)

研究者

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

Lisa M. Quintiliani

Assistant Professor

Boston Medical Center

研究点 (2)

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