Building a Healthy Temple: a Diabetes Self-management Support Program in Hispanic Faith Community Settings
2019年4月30日 更新者：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).
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (予想される)
360
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Texas
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San Antonio、Texas、アメリカ、78249
- 募集
- Human Nutrition Lab, UTSA
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コンタクト：
- Meizi He, PhD
- 電話番号：210-458-5416
- メール：meizi.he@utsa.edu
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コンタクト：
- Christian Umana, B.Sc.
- 電話番号：210-458-7408
- メール：c.umana424@gmail.com
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主任研究者：
- Meizi He, PhD
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
21年～85年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The change in HbA1c
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Waist circumference
時間枠：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
時間枠：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)
時間枠：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
時間枠：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.
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Diabetes self-efficacy
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Meizi He, PhD、The University of Texas at San Antonio
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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
便利なリンク
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年1月1日
一次修了 (予想される)
2020年6月30日
研究の完了 (予想される)
2020年6月30日
試験登録日
最初に提出
2019年3月27日
QC基準を満たした最初の提出物
2019年4月30日
最初の投稿 (実際)
2019年5月2日
学習記録の更新
投稿された最後の更新 (実際)
2019年5月2日
QC基準を満たした最後の更新が送信されました
2019年4月30日
最終確認日
2019年4月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- ADA#1-17-ICTS-029
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD 共有時間枠
Data will be available in December 2020.
IPD 共有アクセス基準
Data access requests will be reviewed by an external independent review panel.
Requestors will be required to sign a Data Access Agreement.
IPD 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
- インフォームド コンセント フォーム (ICF)
- 臨床試験報告書（CSR）
- 分析コード
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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