Building a Healthy Temple: a Diabetes Self-management Support Program in Hispanic Faith Community Settings
试验速览
- 阶段
- 不适用
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- The change in HbA1c
研究概览
简要总结
The present study proposes to test the effectiveness of the Building a Healthy Temple: Diabetes Self-Management Support Program (BHT DSMS), a rendition of the Stanford DSMP in a spiritual context for the Hispanic faith community members. Using a holistic approach through integrating spiritual and physical health, BHT translates the Stanford DSMP in a way that may result in lasting behavior changes and improved diabetes outcomes for Hispanics with type 2 diabetes (T2D).
详细描述
The present study is proposing a 12-month translational study BHT DSMS to test the effectiveness of adapted Stanford DSMP in a spiritual context. A cluster randomized trial with repeated measures will be conducted to compare the effectiveness of DSMS intervention strategies among 360 adult diabetic congregants from 18 predominantly Hispanic churches in San Antonio, Texas (20 participants/church). Using cluster randomized trial design; nine churches will be randomly assigned to the Faith-Based (FB) intervention, and nine to the Faith-Placed (FP) intervention. The study will be implemented in two cohorts (8 churches for cohort 1 & 10 churches for cohort 2). All intervention activities will be implemented over 14 consecutive weeks. Participants in the FB group will participate in BHT DSMS, which includes a Health Sermon, a 6-session Health Bible Study with cooking demonstrations, the Stanford DSMP and a Diabetes Resource Seminar delivered by two trained church lay leaders. Participants in the FP group will first attend a 7-session community health and safety curriculum as a partial attention control intervention, followed by the Stanford DSMP and Diabetes Resource Seminar facilitated by the local public health department. The primary outcome will be a change in HbA1c levels. Secondary outcomes include: changes in body mass index (BMI), waist circumference (WC), quality of life, diabetes self-care behaviors, eating behavior and physical activity level. Data will be collected at baseline, 6, 9, and 12-months during the study period. The aims of present study are 1) To test feasibility of the Stanford DSMP in FP and FB settings through observation and documentation of the implementation process, in-depth interviews with program staff and focus groups with participants to identify facilitators and barriers of the intervention. 2) To translate Stanford DSMP in a spiritual context for Hispanic faith community members and compare the effectiveness of a FB versus FP approach in improving diabetes outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Using cluster randomized trial design; nine churches will be randomly assigned to the FB intervention (BHT DSMS), and nine to the FP intervention (Stanford DSMP).
入排标准
- 年龄范围
- 21 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Church eligibility: [Churches must be predominantly Hispanics (60%) with at least 20 adult congregants with T2D willing to participate in the study. The rationale for 20 diabetic voluntary participants per church is based on the Stanford requirement of 12-16 participants allowed per support group and with an anticipated 25% attrition.]
- •Participants' eligibility: Participants will be adults age 21 and above that have been diagnosed with T2D.
排除标准
- •Children, adults under 21 years of age, and pregnant women
研究组 & 干预措施
Faith-Based (FB, BHT DSMS)
The BHT DSMD intervention strategies adapted Stanford DSMP in a spiritual context is used in this group. Participants in the FB group will participate in BHT DSMS, which includes a Health Sermon, a 6-session Health Bible Study with cooking demonstrations, the Stanford DSMP and a Diabetes Resource Seminar delivered by two trained church lay leaders.
干预措施: Faith-Based (FB, BHT DSMS) (Behavioral)
Faith-Placed (FP, Stanford DSMP)
The traditional Stanford DSMP is conducted in this control group. Participants in the FP group will first attend a 7-session community health and safety curriculum as a partial attention control intervention, followed by the Stanford DSMP and Diabetes Resource Seminar facilitated by the local public health department.
干预措施: Faith-Placed (FP, Stanford DSMP) (Other)
结局指标
主要结局
The change in HbA1c
时间窗: Data is collected at baseline, 6, 9, and 12-months during the study period.
A finger-prick blood sample will be collected for HbA1c testing using Metrika A1cNowTM (Bayer Health Care).
次要结局
- Waist circumference(Data is collected at baseline, 6, 9, and 12-months during the study period.)
- Body Mass Index(Data is collected at baseline, 6, 9, and 12-months during the study period.)
- Quality of Life (QoL)(Data is collected at baseline, 6, 9, and 12-months during the study period.)
- Diabetes Self-care practices(Data is collected at baseline, 6, 9, and 12-months during the study period.)
- The barriers to diabetes care.(Data is collected at baseline, 6, 9, and 12-months during the study period.)
- Physical Activity (PA) level assessment(Data is collected at baseline, 6, 9, and 12-months during the study period.)
- Occupational physical activity(Data is collected at baseline, 6, 9, and 12-months during the study period.)
研究者
Dr. Meizi He
Professor
The University of Texas at San Antonio
