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

Primary Purpose

Type2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Faith-Based (FB, BHT DSMS)
Faith-Placed (FP, Stanford DSMP)
Sponsored by
The University of Texas at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type2 Diabetes Mellitus focused on measuring diabetes, Hispanics, HbA1c, Self-Management Support Program

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Human Nutrition Lab, UTSARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Faith-Based (FB, BHT DSMS)

Faith-Placed (FP, Stanford DSMP)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The change in HbA1c
A finger-prick blood sample will be collected for HbA1c testing using Metrika A1cNowTM (Bayer Health Care).

Secondary Outcome Measures

Waist circumference
waist circumference (WC) will measured in the horizontal plane midway between the lowest rib and the iliac crest.
Body Mass Index
Participants' body weight and height will be measured. BMI will be calculated height and weight (kg/M2)
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
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.
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).
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.
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)

Full Information

First Posted
March 27, 2019
Last Updated
April 30, 2019
Sponsor
The University of Texas at San Antonio
Collaborators
American Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT03934593
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas at San Antonio
Collaborators
American Diabetes Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes Mellitus
Keywords
diabetes, Hispanics, HbA1c, Self-Management Support Program

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
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).
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Faith-Based (FB, BHT DSMS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Faith-Placed (FP, Stanford DSMP)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Faith-Based (FB, BHT DSMS)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Faith-Placed (FP, Stanford DSMP)
Intervention Description
Standard Stanford DSMP delivered by health professional
Primary Outcome Measure Information:
Title
The change in HbA1c
Description
A finger-prick blood sample will be collected for HbA1c testing using Metrika A1cNowTM (Bayer Health Care).
Time Frame
Data is collected at baseline, 6, 9, and 12-months during the study period.
Secondary Outcome Measure Information:
Title
Waist circumference
Description
waist circumference (WC) will measured in the horizontal plane midway between the lowest rib and the iliac crest.
Time Frame
Data is collected at baseline, 6, 9, and 12-months during the study period.
Title
Body Mass Index
Description
Participants' body weight and height will be measured. BMI will be calculated height and weight (kg/M2)
Time Frame
Data is collected at baseline, 6, 9, and 12-months during the study period.
Title
Quality of Life (QoL)
Description
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
Time Frame
Data is collected at baseline, 6, 9, and 12-months during the study period.
Title
Diabetes Self-care practices
Description
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.
Time Frame
Data is collected at baseline, 6, 9, and 12-months during the study period.
Title
The barriers to diabetes care.
Description
The barriers to diabetes care are investigated using selected questions from the National Survey of People with Diabetes (Harris, McGee, and Andrews, 2007).
Time Frame
Data is collected at baseline, 6, 9, and 12-months during the study period.
Title
Physical Activity (PA) level assessment
Description
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.
Time Frame
Data is collected at baseline, 6, 9, and 12-months during the study period.
Title
Occupational physical activity
Description
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)
Time Frame
Data is collected at baseline, 6, 9, and 12-months during the study period.
Other Pre-specified Outcome Measures:
Title
Diabetes self-efficacy
Description
Diabetes self-efficacy scale will assess participants' diabetes self-efficacy (Sarkar, Fisher and Schillinger, 2006). It is an 8-item instrument assessing diabetic individual's self-management efficacy. These items addressed diabetes-specific domains such as confidence in self-monitoring of blood glucose (SMBG), as well as general health domains such as confidence in ability to get medical attention and take care of health using 4-point Likert-scale with responses from "1 = not at all sure" to "4 = very sure." For each item patients rated their confidence in their ability to perform a recommended self-care routine. The overall self-efficacy score are transformed to a 100-point scale with a higher score representing greater self-efficacy.
Time Frame
Data is collected at baseline, 6, 9, and 12-months during the study period.
Title
Social support in a spiritual context
Description
Social support in a religion context will be measured using the instrument by Olphen et al.(2003) that assess the frequency with which participants receive support from other church members by asking "How often do people in your church or place of worship help you out? The answer options include "1= never; 2= hardly ever; 3= not too often; 4= fairly often and 5= very". Higher scores indicate greater levels of level of support.
Time Frame
Data is collected at baseline, 6, 9, and 12-months during the study period.
Title
Social support for diabetes self-management
Description
• Social support for self-management will be assessed using modified Social Support Scale for Self-care in Middle-aged patients with type II diabetes (S4-MAD) (Naderimagham S, Niknami S, 2012) The questions in S4-MAD will be re-classified to evaluate the social support in emotional and information support, tangible support, affectionate support, positive support and additional support (www.rand.org). The social support resources include "Are you attending worship service at this church?", "Who help you the most in caring for your diabetes outside of church?", "Who helps you the most I caring for your diabetes within the church?". The responses will be "1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; 5 = Always". The higher score reflects better spiritual coping.
Time Frame
Data is collected at baseline, 6, 9, and 12-months during the study period.
Title
Spiritual coping
Description
Spiritual coping in the DSMP context will be measured by adapting the RCOPE (Pargament, Koenig, and Perez) instrument particularly measuring spiritual coping strategies identified by diabetic individuals. Areas include "I pray to and believe in God", "God keeps me alive", "I turn things over to God", "God changes my unhealthy behaviors", "God supplies my needs", "I read the Bible", and "I ask religious or spiritual individuals help me". The responses will be "1 = Not at all; 2 = Somewhat; 3 = Quite a bit; 4 = A great deal". The higher score reflects better spiritual coping.
Time Frame
Data is collected at baseline, 6, 9, and 12-months during the study period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meizi He, PhD
Phone
210-458-5416
Email
meizi.he@utsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Leah Carrillo, MS
Phone
210-458-7408
Email
leah.carrillo@utsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meizi He, PhD
Organizational Affiliation
The University of Texas at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Nutrition Lab, UTSA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Umana, B.Sc.
Phone
210-458-7408
Email
c.umana424@gmail.com
First Name & Middle Initial & Last Name & Degree
Meizi He, PhD
Phone
210-458-5416
Email
meizi.he@utsa.edu
First Name & Middle Initial & Last Name & Degree
Meizi He, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available in December 2020.
IPD Sharing Access Criteria
Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.
Citations:
PubMed Identifier
7555499
Citation
Polonsky WH, Anderson BJ, Lohrer PA, Welch G, Jacobson AM, Aponte JE, Schwartz CE. Assessment of diabetes-related distress. Diabetes Care. 1995 Jun;18(6):754-60. doi: 10.2337/diacare.18.6.754.
Results Reference
background
PubMed Identifier
10895844
Citation
Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.
Results Reference
background
PubMed Identifier
16567822
Citation
Sarkar U, Fisher L, Schillinger D. Is self-efficacy associated with diabetes self-management across race/ethnicity and health literacy? Diabetes Care. 2006 Apr;29(4):823-9. doi: 10.2337/diacare.29.04.06.dc05-1615.
Results Reference
background
PubMed Identifier
12848838
Citation
van Olphen J, Schulz A, Israel B, Chatters L, Klem L, Parker E, Williams D. Religious involvement, social support, and health among African-American women on the east side of Detroit. J Gen Intern Med. 2003 Jul;18(7):549-57. doi: 10.1046/j.1525-1497.2003.21031.x.
Results Reference
background
PubMed Identifier
23190685
Citation
Naderimagham S, Niknami S, Abolhassani F, Hajizadeh E, Montazeri A. Development and psychometric properties of a new social support scale for self-care in middle-aged patients with type II diabetes (S4-MAD). BMC Public Health. 2012 Nov 28;12:1035. doi: 10.1186/1471-2458-12-1035.
Results Reference
background
Citation
Harris J, McGee A, Andrews F, D'Souza J and Sproston K. The national survey of people with diabetes. Prepared for the Healthcare Commission Sept 2007.
Results Reference
background
Citation
Lorig K. Outcome measures for health education and other health care interventions. Sage 1996.
Results Reference
background
Citation
Yore MM, Bowles HR, Ainsworth BE, Macera CA, Kohl III HW. Single versus multiple item questions on occupational physical activity. Journal of Physical Activity and Health 3(1), 102-111, 2006
Results Reference
background
Citation
Norris AE, Ford K, Bova CA. Psychometrics of a Brief Acculturation Scale for Hispanics in a probability sample of urban Hispanic adolescents and young adults. Hispanic Journal of Behavioral Sciences 18:29-38 (abstr), 1996
Results Reference
background
Links:
URL
http://www.cdc.gov/brfss/
Description
Occupational physical activity is evaluated using a single-item question recommended by Behavioral Risk Factor Surveillance System (BRFSS) .

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

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