Type2 Diabetes MellitusNCT03934593
Building a Healthy Temple: a Diabetes Self-management Support Program in Hispanic Faith Community Settings
A study testing Faith-Based (FB, BHT DSMS) and Faith-Placed (FP, Stanford DSMP) in people with Type2 Diabetes Mellitus, run by The University of Texas at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Faith-Based (FB, BHT DSMS) and Faith-Placed (FP, Stanford DSMP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Children, adults under 21 years of age, and pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Human Nutrition Lab, UTSA
San Antonio, Texas, 78249
Christian Umana, B.Sc., 210-458-7408, c.umana424@gmail.com
Meizi He, PhD, 210-458-5416, meizi.he@utsa.edu
About this study
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).
Read the 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.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Faith-Based (FB, BHT DSMS), Faith-Placed (FP, Stanford DSMP)
- Keywords
- diabetes, Hispanics, HbA1c, Self-Management Support Program
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faith-Based (FB, BHT DSMS)Behavioural
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.
Faith-Placed (FP, Stanford DSMP)Other
Standard Stanford DSMP delivered by health professional
| Study group | Role | What they receive |
|---|---|---|
| Faith-Based (FB, BHT DSMS) | Experimental | 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. Receives: Behavioral: Faith-Based (FB, BHT DSMS) |
| Faith-Placed (FP, Stanford DSMP) | Active comparator | 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. Receives: Other: Faith-Placed (FP, Stanford DSMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in HbA1c
A finger-prick blood sample will be collected for HbA1c testing using Metrika A1cNowTM (Bayer Health Care).
Measured: Data is collected at baseline, 6, 9, and 12-months during the study period.
Secondary outcomes (7)
Waist circumference
waist circumference (WC) will measured in the horizontal plane midway between the lowest rib and the iliac crest.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: Data is collected at baseline, 6, 9, and 12-months during the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Jan 2017
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Dr. Meizi He, The University of Texas at San Antonio
- Investigators
- Meizi He, PhD, Principal investigator, The University of Texas at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934593
- Sponsor's protocol ID
- ADA#1-17-ICTS-029
- Status last verified
- Apr 2019
- First submitted
- 27 Mar 2019
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
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.
PubMed 7555499Toobert 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.
PubMed 10895844Sarkar 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.
PubMed 16567822van 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.
PubMed 12848838Naderimagham 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.
PubMed 23190685Harris 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.
Lorig K. Outcome measures for health education and other health care interventions. Sage 1996.
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
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
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building a Healthy Temple: a Diabetes Self-management Support Program in Hispanic Faith Community Settings
- ClinicalTrials.gov ID
- NCT03934593
- Acronym / sponsor ID
- ADA#1-17-ICTS-029
- Conditions
- Type2 Diabetes Mellitus
- Keywords
- diabetes, Hispanics, HbA1c, Self-Management Support Program
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- The University of Texas at San AntonioUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Faith-Based (FB, BHT DSMS) | Experimental | Behavioral: 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. |
| Faith-Placed (FP, Stanford DSMP) | Active comparator | Other: 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. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Children, adults under 21 years of age, and pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faith-Based (FB, BHT DSMS)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. | Behavioural | Faith-Based (FB, BHT DSMS) |
| Faith-Placed (FP, Stanford DSMP)Standard Stanford DSMP delivered by health professional | Other | Faith-Placed (FP, Stanford DSMP) |
Primary outcome
The change in HbA1c
Time frame: 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).
7 secondary outcomes
Waist circumference
Time frame: Data is collected at baseline, 6, 9, and 12-months during the study period.
Body Mass Index
Time frame: Data is collected at baseline, 6, 9, and 12-months during the study period.
Quality of Life (QoL)
Time frame: Data is collected at baseline, 6, 9, and 12-months during the study period.
Diabetes Self-care practices
Time frame: Data is collected at baseline, 6, 9, and 12-months during the study period.
The barriers to diabetes care.
Time frame: Data is collected at baseline, 6, 9, and 12-months during the study period.
Physical Activity (PA) level assessment
Time frame: Data is collected at baseline, 6, 9, and 12-months during the study period.
Occupational physical activity
Time frame: Data is collected at baseline, 6, 9, and 12-months during the study period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Background: PubMed 7555499Polonsky 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.
- Background: PubMed 10895844Toobert 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.
- Background: PubMed 16567822Sarkar 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.
- Background: PubMed 12848838van 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.
- Background: PubMed 23190685Naderimagham 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.
- BackgroundHarris 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.
- BackgroundLorig K. Outcome measures for health education and other health care interventions. Sage 1996.
- BackgroundYore 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
- BackgroundNorris 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
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meizi He, PhD principal investigator
The University of Texas at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faith-Based (FB, BHT DSMS) and Faith-Placed (FP, Stanford DSMP) in people with Type2 Diabetes Mellitus, run by The University of Texas at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meizi He, PhD (210-458-5416, meizi.he@utsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in HbA1c (time frame: Data is collected at baseline, 6, 9, and 12-months during the study period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03934593, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.