Building a Healthy Temple: a Diabetes Self-management Support Program in Hispanic Faith Community Settings

Study Overview
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Brief Summary
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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
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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.

Official Title
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Building a Healthy Temple: a Diabetes Self-management Support Program in Hispanic Faith Community Settings

Conditions
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Type2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Faith-Based (FB, BHT DSMS)
* Other: Faith-Placed (FP, Stanford DSMP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Faith-Based (FB, BHT DSMS)<br>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. | Behavioral: Faith-Based (FB, BHT DSMS)<br>* BHT DSMS Intervention components include Health Sermon and a 6-session Health Bible Study with cooking demonstrations, followed by the Stanford DSMP and a Diabetes Resource Seminar. All intervention activities are implemented by trained church lay leaders.<br>|
| Active Comparator: Faith-Placed (FP, Stanford DSMP)<br>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. | Other: Faith-Placed (FP, Stanford DSMP)<br>* Standard Stanford DSMP delivered by health professional<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in HbA1c | A finger-prick blood sample will be collected for HbA1c testing using Metrika A1cNowTM (Bayer Health Care). | Data is collected at baseline, 6, 9, and 12-months during the study period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference | waist circumference (WC) will measured in the horizontal plane midway between the lowest rib and the iliac crest. | Data is collected at baseline, 6, 9, and 12-months during the study period. | 
| Body Mass Index | Participants' body weight and height will be measured. BMI will be calculated height and weight (kg/M2) | Data is collected at baseline, 6, 9, and 12-months during the study period. | 
| Quality of Life (QoL) | Quality of life in present study will be measured using the Problem Areas in Diabetes (PAID) scale (Polonsky and Anderson, 1995). The PAID measure of diabetes related emotional distress correlates with measures of related concepts such as depression, social support, health beliefs, and coping style, as well as predicts future blood glucose control of the patient. Questionnaire scale scoring: Each question has 5 possible answers with a value from 0 to 4, with 0 representing no problem and 4 a serious problem. The scores are added up and multiplied by 1.25, generating a total score between 0 - 100. Patients scoring 40 or higher may be at the level of emotional burnout and warrant special attention. PAID scores in these patients may drop 10-15 points in response to | Data is collected at baseline, 6, 9, and 12-months during the study period. | 
| Diabetes Self-care practices | The Revised Summary of Diabetes Self-Care Activities (SDSCA) (Toobert, Hampson, and Glasgow, 2000). It is a 25-item self-report measure of the frequency of performing diabetes self-care tasks over the preceding 7 days. The response is based on a seven-point Likert scale to answer the question phrased as On how many of the last 7 days did you…?. Higher overall scores reflect good diabetes self-care practice. | Data is collected at baseline, 6, 9, and 12-months during the study period. | 
| The barriers to diabetes care. | The barriers to diabetes care are investigated using selected questions from the National Survey of People with Diabetes (Harris, McGee, and Andrews, 2007). | Data is collected at baseline, 6, 9, and 12-months during the study period. | 
| Physical Activity (PA) level assessment | A 6-item Exercise Behaviors scale (Lorig et al 1996) measures total minutes per week of aerobic and nonaerobic exercise specifically over the past seven days. The first question measures the amount of time that the participant stretched or engaged in any strengthening exercises. The other five questions measures aerobic activity. The options for the questions include none, less than 30 minutes per week, 30-60 minutes per week, 1-3 hours per week, and more than 3 hours per week. The total aerobic and stretching and/or strengthening minutes were calculate by converting the None category to 0 minutes; Less than 30 minutes/week into 15 minutes; 30-60 minutes/week into 45 minutes; 1-3 hours/week into 120 minutes; and More than 3 hours/week into 180 minutes.(6) The response to the first question was used to determine the amount of time for stretching/strengthening while questions 2 through 6 were summed together to determine the amount of aerobic time. | Data is collected at baseline, 6, 9, and 12-months during the study period. | 
| Occupational physical activity | Occupational physical activity also is evaluated using a single-item question recommended by Behavioral Risk Factor Surveillance System (BRFSS) which is designed to categorize occupational physical activity into three components: 1) mostly sitting and standing (inactivity and low-intensity activity); 2) mostly waling (moderate-intensity activity); or 3) mostly heavy labor (vigorous-intensity activity) (www.cdc.gov/brfss/; Yore MM, Bowles HR, 2006) | Data is collected at baseline, 6, 9, and 12-months during the study period. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, Hispanics, HbA1c, Self-Management Support Program