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临床试验/NCT01892124
NCT01892124已完成不适用

Healthy Hearts, Healthy Minds

University of Washington2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2013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
34
试验地点
2
主要终点
Change in Body Mass Index

研究概览

简要总结

American Indians (AIs) living in the Northwest have very high rates of diabetes, obesity, tobacco use, depression, and other risk factors associated with cardiovascular disease. Depression and diabetes have a pernicious effect on CVD risk and susceptibility. This study seeks to build upon the success of the 1-month, 5-session motivational interviewing (MI) CVD prevention component of the həli?dxw Project (aka Healthy Hearts-originally funded under RFA-HL-06-002; U01 HL HL087322-05). həli?dxw successfully culturally adapted MI for CVD prevention for AIs, trained AIs to implement the intervention, and conducted a preliminary feasibility and efficacy trial. Initial results indicated that participants enthusiastically embraced the MI component of the program; however, observations of the counselors, survey data, and feedback from participants suggest that depressive symptomatology served as a barrier to achieving CVD preventive behaviors and desired outcomes; and, that more time and attention to underlying depressive symptomatology may enhance motivation and CVD prevention behaviors, particularly among AIs with pre-diabetes and Type 2 diabetes. Building upon solid preliminary CVD epidemiological data, preliminary acceptability and feasibility of utilizing an MI approach, and motivated by the need to address elevated depression and diabetes profiles from the həli?dxw study, the investigators will develop a 3-month, 10-session MI-based cognitive-behavioral-adherence (MI-CBT-CVD) treatment program to address underlying depressive symptomatology, activate CVD prevention behaviors, and decrease BMI and CVD risk behaviors among 50 pre-and recently diagnosed diabetic AIs at risk for CVD. The study proposes three innovative and significant aims. First, in line with community-based participatory (CBPR) principles and pre-established indigenous research protocols with the tribal community, the investigators will conduct formative research to develop the MI-CBT-CVD intervention. Second, the investigators will conduct a pilot randomized two-group, single-site waitlist-controlled clinical trial of a 10-session, 3-month MI-based cognitive-behavioral treatment for CVD prevention (MI-CBT-CVD) among 50 pre-and recently diagnosed diabetic AI adults with depressive symptomatology and who are also at risk for CVD. Assessments will be conducted at pre and post intervention and at 6-months (3 month follow-up). Third, the investigators will disseminate the findings to the tribe as well as research outlets and prepare an RO1 to conduct a full-scale RCT should the pilot intervention be efficacious, acceptable to the community, and feasible. The primary objectives will be to determine the effect of the proposed culturally-grounded behavioral intervention program on (a) reducing weight as measured by BMI (7-10% reduction in BMI); (b) decreasing depressive symptomatology; (c) increasing physical activity; (d) decreasing sedentary activities; (d) increasing healthful food habits; and (e) improving biomedical outcomes (e.g., blood lipid profiles, glucose, hemoglobin A1C, and blood pressure). The intervention will be culturally relevant and utilize existing Native resources and personnel wherever possible.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be 18 years of age or older
  • Be an American Indian/Alaska Native
  • Currently reside on or within 20 miles of the Tribal reservation boundary
  • Have a Body Mass Index > 25
  • Have a PSS (10 item) score > 15
  • Be pre-diabetic for Type 2 diabetes (via self-report, health provider referral, or previous glucose reading or hemoglobin A1c reading indicating pre-diabetes within the past 12 months) or have been diagnosed as having Type 2 diabetes
  • If a woman, not currently pregnant

排除标准

  • Referred to their physician for approval of participation during the baseline assessment process and the physician does not give approval or the participant refused to follow-up on the referral
  • Unstable or exhibits serious psychiatric symptoms as determined by project's tribal mental health specialist

结局指标

主要结局

Change in Body Mass Index

时间窗: Assessed at baseline, 3 month, and 6 month timepoints

The investigators will compare changes in body mass index between the wait-list control group and the immediate intervention group, and also for each individual over time.

次要结局

  • Changes in Blood Glucose(Assessed at baseline, 3 month, and 6 month timepoints)
  • Changes in Depressive Symptoms using the Center for Epidemiologic Studies Depression Scale (CES-D)(Assessed at baseline, 3 month, and 6 month timepoints)
  • Changes in Blood Lipids(Assessed at baseline, 3 month, and 6 month timepoints)
  • Changes in Hemoglobin A1c(Assessed at baseline, 3 month, and 6 month timepoints)
  • Changes in Blood Pressure(Assessed at baseline, 3 month, and 6 month timepoints)

研究者

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

Karina Walters

Professor, School of Social Work; Director, Indigenous Wellness Research Institute

University of Washington

研究点 (2)

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