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

NCT03934593 | Unknown DMC

• 1 other identifier: ADA#1-17-ICTS-029
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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).

Conditions

Type2 Diabetes Mellitus

Keywords

diabetes; Hispanics; HbA1c; Self-Management Support Program

Outcome Measures

Primary Outcomes (1)

• The change in HbA1c

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

  Data is collected at baseline, 6, 9, and 12-months during the study period.

Secondary Outcomes (7)

• Waist circumference

  Data is collected at baseline, 6, 9, and 12-months during the study period.

• Body Mass Index

  Data is collected at baseline, 6, 9, and 12-months during the study period.

• Quality of Life (QoL)

  Data is collected at baseline, 6, 9, and 12-months during the study period.

• Diabetes Self-care practices

  Data is collected at baseline, 6, 9, and 12-months during the study period.

• The barriers to diabetes care.

  Data is collected at baseline, 6, 9, and 12-months during the study period.

Other Outcomes (4)

• Diabetes self-efficacy

  Data is collected at baseline, 6, 9, and 12-months during the study period.

• Social support in a spiritual context

  Data is collected at baseline, 6, 9, and 12-months during the study period.

• Social support for diabetes self-management

  Data is collected at baseline, 6, 9, and 12-months during the study period.

Study Arms (2)

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.

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.

Other: Faith-Placed (FP, Stanford DSMP)

Interventions

Faith-Based (FB, BHT DSMS) 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-Based (FB, BHT DSMS)

Faith-Placed (FP, Stanford DSMP) OTHER

Standard Stanford DSMP delivered by health professional

Faith-Placed (FP, Stanford DSMP)

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Children, adults under 21 years of age, and pregnant women

Sponsors & Collaborators

• The University of Texas at San Antonio: lead
• American Diabetes Association: collaborator

Study Sites (1)

Human Nutrition Lab, UTSA

San Antonio, Texas, 78249, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 7555499 BACKGROUND

• 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.

  PMID: 10895844 BACKGROUND

• 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.

  PMID: 16567822 BACKGROUND

• 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.

  PMID: 12848838 BACKGROUND

• 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.

  PMID: 23190685 BACKGROUND

• 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.

  BACKGROUND

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

  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

  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

  BACKGROUND

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Meizi He, PhD

  The University of Texas at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meizi He, PhD

CONTACT

210-458-5416; meizi.he@utsa.edu

Leah Carrillo, MS

CONTACT

210-458-7408; leah.carrillo@utsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: May 2, 2019
• Study Start: January 1, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: May 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available in December 2020.
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.

Locations

US (1)