Clinical trial NCT03934593: Building a Healthy Temple: a Diabetes Self-management Support Program in Hispanic Faith Community Settings
Official title: Building a Healthy Temple: a Diabetes Self-management Support Program in Hispanic Faith Community Settings
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type2 Diabetes Mellitus
Keywords: diabetes
Hispanics
HbA1c
Self-Management Support Program
Lead sponsor: The University of Texas at San Antonio
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2019-05-02
Enrollment: 360
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will conduct a cluster randomized trial with repeated measures to compare the effectiveness of BHT DSMS intervention strategies among 360 adult diabetic congregants from 18 predominantly Hispanic churches in San Antonio, Texas (20 participants/church).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Children, adults under 21 years of age, and pregnant women

Primary outcomes:
measure: The change in HbA1c
timeFrame: Data is collected at baseline, 6, 9, and 12-months during the study period.
Secondary outcomes:
measure: Waist circumference
timeFrame: Data is collected at baseline, 6, 9, and 12-months during the study period.
measure: Body Mass Index
timeFrame: Data is collected at baseline, 6, 9, and 12-months during the study period.
measure: Quality of Life (QoL)
timeFrame: Data is collected at baseline, 6, 9, and 12-months during the study period.
measure: Diabetes Self-care practices
timeFrame: Data is collected at baseline, 6, 9, and 12-months during the study period.
measure: The barriers to diabetes care.
timeFrame: Data is collected at baseline, 6, 9, and 12-months during the study period.
measure: Physical Activity (PA) level assessment
timeFrame: Data is collected at baseline, 6, 9, and 12-months during the study period.
measure: Occupational physical activity
timeFrame: Data is collected at baseline, 6, 9, and 12-months during the study period.
Other outcomes:
measure: Diabetes self-efficacy
timeFrame: Data is collected at baseline, 6, 9, and 12-months during the study period.
measure: Social support in a spiritual context
timeFrame: Data is collected at baseline, 6, 9, and 12-months during the study period.
measure: Social support for diabetes self-management
timeFrame: Data is collected at baseline, 6, 9, and 12-months during the study period.
measure: Spiritual coping
timeFrame: Data is collected at baseline, 6, 9, and 12-months during the study period.
Locations:
city: San Antonio
country: United States
facility: Human Nutrition Lab, UTSA
state: Texas
Study officials:
affiliation: The University of Texas at San Antonio
name: Meizi He, PhD
role: PRINCIPAL_INVESTIGATOR
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