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

NCT ID: NCT03934593

Last Updated: 2019-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2020-06-30

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.

Conditions

Type2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Faith-Based (FB, BHT DSMS)

Intervention Type: BEHAVIORAL

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)

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.

Group Type: ACTIVE_COMPARATOR

Faith-Placed (FP, Stanford DSMP)

Intervention Type: OTHER

Standard Stanford DSMP delivered by health professional

Interventions

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.

Intervention Type: BEHAVIORAL

Faith-Placed (FP, Stanford DSMP)

Standard Stanford DSMP delivered by health professional

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

The University of Texas at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Dr. Meizi He

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meizi He, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at San Antonio

Locations

Human Nutrition Lab, UTSA

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Meizi He, PhD

Role: CONTACT

meizi.he@utsa.edu

210-458-5416

Leah Carrillo, MS

Role: CONTACT

leah.carrillo@utsa.edu

210-458-7408

Facility Contacts

Christian Umana, B.Sc.

Role: primary

c.umana424@gmail.com

210-458-7408

Meizi He, PhD

Role: backup

meizi.he@utsa.edu

210-458-5416

References

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Reference Type: BACKGROUND

PMID: 7555499 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10895844 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16567822 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 12848838 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23190685 (View on PubMed)

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.

Reference Type: BACKGROUND

Lorig K. Outcome measures for health education and other health care interventions. Sage 1996.

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Related Links

http://www.cdc.gov/brfss/

Occupational physical activity is evaluated using a single-item question recommended by Behavioral Risk Factor Surveillance System (BRFSS) .

Other Identifiers

ADA#1-17-ICTS-029

Identifier Type: -

Identifier Source: org_study_id