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Project Dulce for Arab-Americans With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project Dulce + Dulce Digital
Sponsored by
Scripps Whittier Diabetes Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Self-identified Arab
  • Diagnosed with type 2 diabetes mellitus (T2DM)
  • Registered in the community clinic (or willing to register)
  • HbA1c ≥8% within 1 month of screening
  • Able to speak, read, write, and comprehend in English and Arabic

Exclusion Criteria:

  • Severe illness precluding frequent visits to clinic
  • Liver function tests (ALT and AST) > 3 times the upper limit of normal
  • Body mass index ≤ 23 kg/cm
  • History of malignancy, except subjects who have been disease-free for > 5 years, or whose only malignancy has been basal or squamous cell skin carcinoma
  • Creatinine > 3.5
  • History of drug or alcohol abuse within 12 months prior to enrollment
  • Not a permanent resident in the area
  • Current enrollee in Project Dulce
  • Blood donation of one pint or more within the past 30 days, or plasma donation within 7 days prior to screening
  • Anemia
  • Primary language other than English or Arabic
  • Not willing to carry a mobile phone
  • Type 1 or gestational diabetes
  • Pregnant

Sites / Locations

  • San Ysidro HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Project Dulce + Dulce Digital

Arm Description

Participants will participate in a peer-led group diabetes self-management education and support program and receive ongoing support via text messages designed to improve knowledge, health beliefs, self-management behaviors and clinical outcomes.

Outcomes

Primary Outcome Measures

Change from Baseline Diabetes Knowledge at 3 months
Diabetes Knowledge Test (Diabetes Research and Training Center, University of Michigan, 2015) is a 23-item measure of diabetes knowledge, with general questions related to symptoms, self-management (e.g., diet, exercise, foot care, blood glucose monitoring, insulin), and complications (e.g., low, and high blood sugar). Greater scores indicate greater diabetes knowledge.
Change from Baseline Diabetes Knowledge at 6 months
Diabetes Knowledge Test (Diabetes Research and Training Center, University of Michigan, 2015) is a 23-item measure of diabetes knowledge, with general questions related to symptoms, self-management (e.g., diet, exercise, foot care, blood glucose monitoring, insulin), and complications (e.g., low, and high blood sugar). Greater scores indicate greater diabetes knowledge.
Change from Baseline Health Belief Model Scale at 3 months
Health Belief Model scale (Tan, 2004) is comprised of 36 items that evaluate the health beliefs and attitudes about complications prevention behaviors and active health related behaviors in individuals with diabetes. Responses are on a 5-point Likert-type scale (1=strongly disagree, 5=strongly agree), with lower scores indicating greater negative beliefs.
Change from Baseline Health Belief Model Scale at 6 months
Health Belief Model scale (Tan, 2004) is comprised of 36 items that evaluate the health beliefs and attitudes about complications prevention behaviors and active health related behaviors in individuals with diabetes. Responses are on a 5-point Likert-type scale (1=strongly disagree, 5=strongly agree), with lower scores indicating greater negative beliefs.
Change in Baseline Self-Efficacy for Diabetes Scale at 3 months
Stanford Self-Efficacy for Diabetes Scale (Lorig, Stewart, Ritter, et al., 1996) is comprised of 8 items that measure the confidence of a participant in performing self-care activities such as eating meals every 4 to 5 hours, following a healthful diet, exercising, and blood glucose monitoring. Response options range from 1=not at all confident to 10=totally confident, with higher scores indicating greater self-efficacy.
Change in Baseline Self-Efficacy for Diabetes Scale at 6 months
Stanford Self-Efficacy for Diabetes Scale (Lorig, Stewart, Ritter, et al., 1996) is comprised of 8 items that measure the confidence of a participant in performing self-care activities such as eating meals every 4 to 5 hours, following a healthful diet, exercising, and blood glucose monitoring. Response options range from 1=not at all confident to 10=totally confident, with higher scores indicating greater self-efficacy.
Understanding Health Implications of Genomics at 3 months
To assess the genetic knowledge, a 12-items questionnaire. Response options are 'agree', 'disagree', or 'don't know'. Similarly, a 13-items questionnaire with response options of 'agree' or 'disagree' will be used to assess the attitudes toward genetics research and testing.
Understanding Health Implications of Genomics at 6 months
To assess the genetic knowledge, a 12-item questionnaire. Response options are 'agree', 'disagree', or 'don't know'. Similarly, a 13-item questionnaire with response options of 'agree' or 'disagree' will be used to assess the attitudes toward genetics research and testing.

Secondary Outcome Measures

Change in Baseline Summary of Diabetes Self-Care Activities at 3 months
Summary of Diabetes Self-Care Activities measure (Toobert, Hampson, & Glassgow, 2000) is a 13-item brief questionnaire that assesses a respondent's adherence to self-management behavior recommendations in the past 7 days, including general and specific diet, exercise, blood glucose testing, foot care, medication adherence, and smoking, with greater scores indicating greater adherence.
Change in Baseline Summary of Diabetes Self-Care Activities at 6 months
Summary of Diabetes Self-Care Activities measure (Toobert, Hampson, & Glassgow, 2000) is a 13-item brief questionnaire that assesses a respondent's adherence to self-management behavior recommendations in the past 7 days, including general and specific diet, exercise, blood glucose testing, foot care, medication adherence, and smoking, with greater scores indicating greater adherence.
Change in Baseline International Physical Activity Questionnaire-Short Form at 3 months
International Physical Activity -Short Form (Craig et al., 2003) assesses the amount of physical activity (work, leisure, and other) and sedentary time in the past 7 days.
Change in Baseline International Physical Activity Questionnaire-Short Form at 6 months
International Physical Activity -Short Form (Craig et al., 2003) assesses the amount of physical activity (work, leisure, and other) and sedentary time in the past 7 days.
Change in Baseline Food Frequency Questionnaire at 3 months
Food frequency questionnaire (Alqahtani et al., 2017) measures the amounts and frequencies of fruits, vegetables, and common foods in the Arab American community.
Change in Baseline Food Frequency Questionnaire at 6 months
Food frequency questionnaire (Alqahtani et al., 2017) measures the amounts and frequencies of fruits, vegetables, and common foods in the Arab American community.
Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months
Samples will be processed by Quest Diagnostics Inc and assayed by Immunoturbidimetry (Integra 800, Roche).
Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months
Samples will be processed by Quest Diagnostics Inc and assayed by Immunoturbidimetry (Integra 800, Roche).

Full Information

First Posted
October 12, 2022
Last Updated
February 20, 2023
Sponsor
Scripps Whittier Diabetes Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05580536
Brief Title
Project Dulce for Arab-Americans With Type 2 Diabetes
Official Title
Project Dulce for Arab-Americans With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scripps Whittier Diabetes Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Arab Americans (AA) face many challenges in diabetes self-management due to the limited educational resources and support available for them. The cultural and linguistic barriers between patients and health care providers lead to poor diabetes management and outcomes. This study (Project Dulce Arabic) is adapted from the Project Dulce, an American Diabetes Association (ADA)-recognized Diabetes Self-Management Education Support (DSMES) program. Project Dulce Arabic comprises both peer-led diabetes education in Arabic and a 3-month text messaging program (Dulce Digital). The main aim of the study is to examine the effectiveness of a more culturally and linguistically appropriate diabetes education program in improving diabetes knowledge, beliefs, and self-management as well as hemoglobin A1C.
Detailed Description
Although the Arab American (AA) population is at a higher risk of pre-diabetes and type 2 diabetes (T2D) compared to the white non-Hispanic population, there are hardly any culturally appropriate diabetes self-management resources available for Arab Americans. Project Dulce Arabic is a pilot study addressing both the linguistic and cultural barriers faced by the AA community in diabetes self-management while exploring the genetic background of type 2 diabetes in Arab Americans. To overcome the linguistic barriers, we adapt educational materials from the Project Dulce diabetes self-management study of Mexican Americans (A. Philis-Tsimikas et al., 2011). This 5-week peer-led educational program in Arabic aims to enhance type 2 diabetes knowledge, beliefs, and self-management behaviors as well as improving diabetes management measured by hemoglobin A1C after 3 months and 6 months in the study. Project Dulce Arabic is incorporating genetic education as a part of its curriculum to raise the community awareness of the role of genetics in T2D development as well as the importance of early genetic risk detection for T2D prevention. We are also asking our Project Dulce Arabic participants to participate in the Scripps Bio-Repository (https://www.scripps.org/research/bio-repository). The specimens obtained from our study cohort will be used for genetic sequencing. Obtaining this genetic information will enable us to gain more insights into the genetic basis of type 2 diabetes in Arab Americans. Comparing the genetic risk of T2D, available from different biobanks, in other ethnic groups with that in Arab Americans would highlight the disease risk faced by the community and draw more attention towards the importance of early disease detection and prevention through tailored screening recommendations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Project Dulce + Dulce Digital
Arm Type
Other
Arm Description
Participants will participate in a peer-led group diabetes self-management education and support program and receive ongoing support via text messages designed to improve knowledge, health beliefs, self-management behaviors and clinical outcomes.
Intervention Type
Behavioral
Intervention Name(s)
Project Dulce + Dulce Digital
Intervention Description
Project Dulce is a 5-week curriculum, group diabetes self-management education and support, program delivered by a peer educator in Arabic. The curriculum provides knowledge as well as skills and tools needed to change behaviors and adapt to a life with type 2 diabetes. The curriculum covers diabetes and its complication, the role of diet, exercise, and medication, and the importance of self-monitoring as well as the genetics contribution to diabetes development. It is presented over 5 weeks where participants will learn and practice diabetes self-management skills, and help one another address family, cultural, or health system barriers to managing their diabetes. . Following the 5-week curriculum, participants will be enrolled in the digital texting platform, Dulce Digital, in which they will receive on-going support via text messages derived from the curriculum, medication reminders, and blood glucose monitoring prompts in Arabic.
Primary Outcome Measure Information:
Title
Change from Baseline Diabetes Knowledge at 3 months
Description
Diabetes Knowledge Test (Diabetes Research and Training Center, University of Michigan, 2015) is a 23-item measure of diabetes knowledge, with general questions related to symptoms, self-management (e.g., diet, exercise, foot care, blood glucose monitoring, insulin), and complications (e.g., low, and high blood sugar). Greater scores indicate greater diabetes knowledge.
Time Frame
3 months
Title
Change from Baseline Diabetes Knowledge at 6 months
Description
Diabetes Knowledge Test (Diabetes Research and Training Center, University of Michigan, 2015) is a 23-item measure of diabetes knowledge, with general questions related to symptoms, self-management (e.g., diet, exercise, foot care, blood glucose monitoring, insulin), and complications (e.g., low, and high blood sugar). Greater scores indicate greater diabetes knowledge.
Time Frame
6 months
Title
Change from Baseline Health Belief Model Scale at 3 months
Description
Health Belief Model scale (Tan, 2004) is comprised of 36 items that evaluate the health beliefs and attitudes about complications prevention behaviors and active health related behaviors in individuals with diabetes. Responses are on a 5-point Likert-type scale (1=strongly disagree, 5=strongly agree), with lower scores indicating greater negative beliefs.
Time Frame
3 months
Title
Change from Baseline Health Belief Model Scale at 6 months
Description
Health Belief Model scale (Tan, 2004) is comprised of 36 items that evaluate the health beliefs and attitudes about complications prevention behaviors and active health related behaviors in individuals with diabetes. Responses are on a 5-point Likert-type scale (1=strongly disagree, 5=strongly agree), with lower scores indicating greater negative beliefs.
Time Frame
6 months
Title
Change in Baseline Self-Efficacy for Diabetes Scale at 3 months
Description
Stanford Self-Efficacy for Diabetes Scale (Lorig, Stewart, Ritter, et al., 1996) is comprised of 8 items that measure the confidence of a participant in performing self-care activities such as eating meals every 4 to 5 hours, following a healthful diet, exercising, and blood glucose monitoring. Response options range from 1=not at all confident to 10=totally confident, with higher scores indicating greater self-efficacy.
Time Frame
3 months
Title
Change in Baseline Self-Efficacy for Diabetes Scale at 6 months
Description
Stanford Self-Efficacy for Diabetes Scale (Lorig, Stewart, Ritter, et al., 1996) is comprised of 8 items that measure the confidence of a participant in performing self-care activities such as eating meals every 4 to 5 hours, following a healthful diet, exercising, and blood glucose monitoring. Response options range from 1=not at all confident to 10=totally confident, with higher scores indicating greater self-efficacy.
Time Frame
6 months
Title
Understanding Health Implications of Genomics at 3 months
Description
To assess the genetic knowledge, a 12-items questionnaire. Response options are 'agree', 'disagree', or 'don't know'. Similarly, a 13-items questionnaire with response options of 'agree' or 'disagree' will be used to assess the attitudes toward genetics research and testing.
Time Frame
3 months
Title
Understanding Health Implications of Genomics at 6 months
Description
To assess the genetic knowledge, a 12-item questionnaire. Response options are 'agree', 'disagree', or 'don't know'. Similarly, a 13-item questionnaire with response options of 'agree' or 'disagree' will be used to assess the attitudes toward genetics research and testing.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Baseline Summary of Diabetes Self-Care Activities at 3 months
Description
Summary of Diabetes Self-Care Activities measure (Toobert, Hampson, & Glassgow, 2000) is a 13-item brief questionnaire that assesses a respondent's adherence to self-management behavior recommendations in the past 7 days, including general and specific diet, exercise, blood glucose testing, foot care, medication adherence, and smoking, with greater scores indicating greater adherence.
Time Frame
3 months
Title
Change in Baseline Summary of Diabetes Self-Care Activities at 6 months
Description
Summary of Diabetes Self-Care Activities measure (Toobert, Hampson, & Glassgow, 2000) is a 13-item brief questionnaire that assesses a respondent's adherence to self-management behavior recommendations in the past 7 days, including general and specific diet, exercise, blood glucose testing, foot care, medication adherence, and smoking, with greater scores indicating greater adherence.
Time Frame
6 months
Title
Change in Baseline International Physical Activity Questionnaire-Short Form at 3 months
Description
International Physical Activity -Short Form (Craig et al., 2003) assesses the amount of physical activity (work, leisure, and other) and sedentary time in the past 7 days.
Time Frame
3 months
Title
Change in Baseline International Physical Activity Questionnaire-Short Form at 6 months
Description
International Physical Activity -Short Form (Craig et al., 2003) assesses the amount of physical activity (work, leisure, and other) and sedentary time in the past 7 days.
Time Frame
6 months
Title
Change in Baseline Food Frequency Questionnaire at 3 months
Description
Food frequency questionnaire (Alqahtani et al., 2017) measures the amounts and frequencies of fruits, vegetables, and common foods in the Arab American community.
Time Frame
3 months
Title
Change in Baseline Food Frequency Questionnaire at 6 months
Description
Food frequency questionnaire (Alqahtani et al., 2017) measures the amounts and frequencies of fruits, vegetables, and common foods in the Arab American community.
Time Frame
6 months
Title
Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months
Description
Samples will be processed by Quest Diagnostics Inc and assayed by Immunoturbidimetry (Integra 800, Roche).
Time Frame
3 months
Title
Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months
Description
Samples will be processed by Quest Diagnostics Inc and assayed by Immunoturbidimetry (Integra 800, Roche).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Self-identified Arab Diagnosed with type 2 diabetes mellitus (T2DM) Registered in the community clinic (or willing to register) HbA1c ≥8% within 1 month of screening Able to speak, read, write, and comprehend in English and Arabic Exclusion Criteria: Severe illness precluding frequent visits to clinic Liver function tests (ALT and AST) > 3 times the upper limit of normal Body mass index ≤ 23 kg/cm History of malignancy, except subjects who have been disease-free for > 5 years, or whose only malignancy has been basal or squamous cell skin carcinoma Creatinine > 3.5 History of drug or alcohol abuse within 12 months prior to enrollment Not a permanent resident in the area Current enrollee in Project Dulce Blood donation of one pint or more within the past 30 days, or plasma donation within 7 days prior to screening Anemia Primary language other than English or Arabic Not willing to carry a mobile phone Type 1 or gestational diabetes Pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Khattab, MD
Phone
8586787049
Email
akhattab@scripps.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Khattab, MD
Organizational Affiliation
Scripps
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Ysidro Health
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Khattab, MD
Phone
858-678-7049
Email
akhattab@scripps.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Project Dulce for Arab-Americans With Type 2 Diabetes

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