Building a Healthy Temple: a Diabetes Self-management Support Program in Hispanic Faith Community Settings
30. dubna 2019 aktualizováno: Dr. Meizi He, The University of Texas at San Antonio
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).
Přehled studie
Postavení
Neznámý
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Očekávaný)
360
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Meizi He, PhD
- Telefonní číslo: 210-458-5416
- E-mail: meizi.he@utsa.edu
Studijní záloha kontaktů
- Jméno: Leah Carrillo, MS
- Telefonní číslo: 210-458-7408
- E-mail: leah.carrillo@utsa.edu
Studijní místa
-
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Texas
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San Antonio, Texas, Spojené státy, 78249
- Nábor
- Human Nutrition Lab, UTSA
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Kontakt:
- Meizi He, PhD
- Telefonní číslo: 210-458-5416
- E-mail: meizi.he@utsa.edu
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Kontakt:
- Christian Umana, B.Sc.
- Telefonní číslo: 210-458-7408
- E-mail: c.umana424@gmail.com
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Vrchní vyšetřovatel:
- Meizi He, PhD
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
21 let až 85 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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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.
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Aktivní komparátor: 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.
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Standard Stanford DSMP delivered by health professional
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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The change in HbA1c
Časové okno: Data is collected at baseline, 6, 9, and 12-months during the study period.
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A finger-prick blood sample will be collected for HbA1c testing using Metrika A1cNowTM (Bayer Health Care).
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Data is collected at baseline, 6, 9, and 12-months during the study period.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Waist circumference
Časové okno: Data is collected at baseline, 6, 9, and 12-months during the study period.
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waist circumference (WC) will measured in the horizontal plane midway between the lowest rib and the iliac crest.
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Data is collected at baseline, 6, 9, and 12-months during the study period.
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Body Mass Index
Časové okno: Data is collected at baseline, 6, 9, and 12-months during the study period.
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Participants' body weight and height will be measured.
BMI will be calculated height and weight (kg/M2)
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Data is collected at baseline, 6, 9, and 12-months during the study period.
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Quality of Life (QoL)
Časové okno: Data is collected at baseline, 6, 9, and 12-months during the study period.
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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
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Data is collected at baseline, 6, 9, and 12-months during the study period.
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Diabetes Self-care practices
Časové okno: Data is collected at baseline, 6, 9, and 12-months during the study period.
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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.
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Data is collected at baseline, 6, 9, and 12-months during the study period.
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The barriers to diabetes care.
Časové okno: Data is collected at baseline, 6, 9, and 12-months during the study period.
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The barriers to diabetes care are investigated using selected questions from the National Survey of People with Diabetes (Harris, McGee, and Andrews, 2007).
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Data is collected at baseline, 6, 9, and 12-months during the study period.
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Physical Activity (PA) level assessment
Časové okno: Data is collected at baseline, 6, 9, and 12-months during the study period.
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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.
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Data is collected at baseline, 6, 9, and 12-months during the study period.
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Occupational physical activity
Časové okno: Data is collected at baseline, 6, 9, and 12-months during the study period.
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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)
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Data is collected at baseline, 6, 9, and 12-months during the study period.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Diabetes self-efficacy
Časové okno: Data is collected at baseline, 6, 9, and 12-months during the study period.
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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.
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Data is collected at baseline, 6, 9, and 12-months during the study period.
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Social support in a spiritual context
Časové okno: Data is collected at baseline, 6, 9, and 12-months during the study period.
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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.
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Data is collected at baseline, 6, 9, and 12-months during the study period.
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Social support for diabetes self-management
Časové okno: Data is collected at baseline, 6, 9, and 12-months during the study period.
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• 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.
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Data is collected at baseline, 6, 9, and 12-months during the study period.
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Spiritual coping
Časové okno: Data is collected at baseline, 6, 9, and 12-months during the study period.
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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.
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Data is collected at baseline, 6, 9, and 12-months during the study period.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Meizi He, PhD, The University of Texas at San Antonio
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Užitečné odkazy
- Occupational physical activity is evaluated using a single-item question recommended by Behavioral Risk Factor Surveillance System (BRFSS) .
- The questions in social support for self-management is re-classified to evaluate the social support in emotional and information support, tangible support, affectionate support, positive support and additional support.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. ledna 2017
Primární dokončení (Očekávaný)
30. června 2020
Dokončení studie (Očekávaný)
30. června 2020
Termíny zápisu do studia
První předloženo
27. března 2019
První předloženo, které splnilo kritéria kontroly kvality
30. dubna 2019
První zveřejněno (Aktuální)
2. května 2019
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
2. května 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
30. dubna 2019
Naposledy ověřeno
1. dubna 2019
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ADA#1-17-ICTS-029
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ano
Popis plánu IPD
De-identified individual participant data for all primary and secondary outcome measures will be made available.
Časový rámec sdílení IPD
Data will be available in December 2020.
Kritéria přístupu pro sdílení IPD
Data access requests will be reviewed by an external independent review panel.
Requestors will be required to sign a Data Access Agreement.
Typ podpůrných informací pro sdílení IPD
- Protokol studie
- Plán statistické analýzy (SAP)
- Formulář informovaného souhlasu (ICF)
- Zpráva o klinické studii (CSR)
- Analytický kód
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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