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| ID | Type | Description | Link |
|---|---|---|---|
| 2P20MD002289-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| University of North Carolina, Greensboro | OTHER |
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The aim of this study was to compare the efficacy of an intervention and an attention control group in producing changes in diabetes self-management, glycemic control (HbA1c) and health related quality of life in Hispanics with type 2 diabetes.
Hypothesis: The experimental group who receive an 8 week intervention program would show significantly greater improvements than an attention control group at 1 and 6 months after the intervention in: behavioral influences of diabetes knowledge, diabetes self-efficacy, and family support, outcomes of self-reported management of diabetes (physical activity, diet, medications, and glucose monitoring), HbA1c levels, and psychological outcomes of health-related quality of life.
A total of 186 participants and their family members were recruited, 103 in the experimental group and 83 in the attention control group.
An intervention consisted of eight weekly interactive modules, for a total of 12 hours, and based on modules from National Standards for Diabetes Self-Management Education, and the National Diabetes Education Program. Data were collected at baseline, immediately post-intervention, and at 3 and 6 month follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Diabetes self-management and family support |
|
| Attention control group | Active Comparator | General health information |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes self-management program for Hispanics and their families | Behavioral | The intervention group received an 8-weekly culturally tailored diabetes self-management and family support education program delivered in Spanish |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C | Glycemic control in %. | Week 0 (Baseline) |
| Hemoglobin A1c | Glycemic control | Month 2 (post-intervention) |
| Hemoglobin A1c | Glycemic control | Month 3 (one month post-intervention) |
| Hemoglobin A1c | Glycemic control | Month 9 (6 months post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Health-related Quality of Life (SF-12) | The Medical Outcomes Study Short Form Health Survey Version 2 (SF-12). Physical Components Summary (PCS) and Mental Components Summary (MCS) were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life. | Week 0 (Baseline) |
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Inclusion Criteria for participants:
Inclusion criteria for family members/relatives are:
Exclusion Criteria:
We will exclude Hispanic adults and family members who are:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Hu, PhD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University College of Nursing | Columbus | Ohio | 43231 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26957533 | Result | Hu J, Amirehsani KA, Wallace DC, McCoy TP, Silva Z. A Family-Based, Culturally Tailored Diabetes Intervention for Hispanics and Their Family Members. Diabetes Educ. 2016 Jun;42(3):299-314. doi: 10.1177/0145721716636961. Epub 2016 Mar 8. |
| Label | URL |
|---|---|
| A Family-Based, Culturally Tailored Diabetes Intervention for Hispanics and Their Family Members | View source |
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Participants who had T2DM and their family members were recruited at 6 sites including clinics, physician offices, and churches in rural counties in central North Carolina between June 2012 and May 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | A Family-Based Diabetes Self-Management Intervention |
| FG001 | Attention Control | General Health Education |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Family-based Diabetes Intervention | The family-based intervention consisted of eight weekly group sessions for participants with diabetes and family members and two sessions (baseline and T4) with the family for data collection. |
| BG001 | Attention Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hemoglobin A1C | Glycemic control in %. | Hispanic adults with type 2 diabetes and their family members | Posted | Mean | 95% Confidence Interval | mean percentage of HbA1c | Week 0 (Baseline) |
|
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Family-based diabetes self-management | 0 |
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The study used a quasi-experimental design.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jie Hu | The Ohio State University | 6146880394 | hu.1348@osu.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| General health educational program for Hispanics and their families | Behavioral | The attention control group received 8-weekly education program on general health information |
|
| Health-related Quality of Life (SF-12) |
Medical Outcomes Study Short Form Health Survey Version 2 (SF-12) Physical Components Summary (PCS) and Mental Components Summary (MCS) scores were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life. |
| Month 2 (post-intervention) |
| Health-related Quality of Life (SF-12) | Medical Outcomes Study Short Form Health Survey Version 2 (SF-12) Physical Components Summary (PCS) and Mental Components Summary (MCS) scores were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life. | Month 3 (one month post-intervention) |
| Health-related Quality of Life (SF-12) | The Medical Outcomes Study Short Form Health Survey, the SF-12 PCS and MCS scores were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life | Month 9 (6 months post-intervention) |
Participants and their family members in the attention control group received eight weekly group sessions on general health information and two sessions with the family for data collection in addition to usual care. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Self-reported ethnicity | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Body Mass Index in kg/m2 | Mean | Standard Deviation | kg/m2 |
|
| Systolic Blood pressure | Systolic blood pressure (SBP) was measured in mean scores in mmHg ranging from 100 mmHg to 190mmHg. Participants were considered hypertensive if they used antihypertensive medications or had blood pressure ≥130/80 mmHg. | Mean | Standard Deviation | mmHg |
|
| Physical Activity (the Short International Physical Activity Questionnaire) | Physical Activity (PA) was measured using the Short International Physical Activity Questionnaire (IPAQ) form, Spanish version, Last 7 Days Recall.Total physical activity metabolic equivalent of minutes/week are estimated (MET min/wk). High MET min/wk indicates high level of physical activity. | Mean | Standard Deviation | MET min/week |
|
| Dietary Intake ( BFRSS fruits/vegetables) servings/day | Diet was assessed using questions about frequency of fruits and vegetables consumption within the Behavioral Risk Factor Surveillance Survey (BRFSS).Fruits/vegetables consumed/day were calculated with its frequencies. Total mean scores were used ranging from 0 to 5. High number refers to high fruits and vegetables consumption/day. | Mean | Standard Deviation | servings/day |
|
| Family Support (Supportive Resources (CIRS)) | Family support was examined using the brief Chronic Illness Resources Survey (CIRS), Spanish version. The CIRS asks items on a 5-point Likert scale ranging from 1-5 that assesses social-environmental support of family members and friends, neighborhood, and community to the person with Type 2 diabetes in medication taking and exercise and diet in the past 6 months. Total mean scores were used. Higher scores indicate stronger perceived family support. | Mean | Standard Deviation | scores on a scale |
|
| Diabetes self-efficacy (DSE) | The Stanford Diabetes Self-Efficacy (DSE), Spanish version, is an 8-item scale that measures the confidence of a person with diabetes to manage diet, exercise, and blood sugar and maintain control over the diabetes. Each of the 8 items are measured on a 10-point Likert type rating response scale ranging from 1-10. The 8 items were averaged together to calculate a total score. Higher scores indicate higher self-efficacy. | Mean | Standard Deviation | scores on a scale |
|
| Diabetes self-management (Revised Summary of Diabetes Self-Care Activities) | Diabetes self-management was measured by the Revised Summary of Diabetes Self-Care Activities (SDSCA), Spanish version, which assessed diet, exercise, glucose testing, medication, and foot care over the past 7 days. The mean number of days per week of diabetes self-care activities were calculated ranging from 0-7, with higher scores indicating better diabetes self-management. | Mean | Standard Deviation | days/week |
|
| Diabetes knowledge (Spoken Knowledge of Diabetes in Low Literacy Patients with Diabetes ) | Diabetes knowledge was measured by the Spoken Knowledge of Diabetes in Low Literacy Patients with Diabetes (SKILLD),which assesses knowledge of glucose management, lifestyle modifications, recognition and treatment of acute complications, and activities to prevent long-term consequences of the disease.This is a verbally administered scale consisting of 10 items with scores ranging from 0 to 10 where higher scores indicate better diabetes knowledge.Total mean scores were calculated. | Mean | Standard Deviation | scores on a scale |
|
| Medical Outcomes Study Short Form Health Survey Version 2 (SF-12v2) | Health-related quality of life was measured by the Spanish version of the Medical Outcomes Study Short Form Health Survey Version 2 (SF-12v2).29 The SF-12v2 assessed self-reported health-related quality of life through physical (PCS) and mental (MCS) component summaries. The SF-12v2 uses Likert rating scales. The PCS and MCS scores were transformed ranging from 0-100. High scores indicate better perceived health-related quality of life. Total mean scores were calculated. | Mean | Standard Deviation | scores on a scale |
|
| HbA1c | Glycemic control was measured with glycosylated hemoglobin A1C. Higher percent indicates worse diabetes control. The total mean scores were calculated. | Mean | Standard Deviation | percent |
|
| Participants |
|
|
| Primary | Hemoglobin A1c | Glycemic control | Posted | Mean | 95% Confidence Interval | percentage of HbA1c | Month 2 (post-intervention) |
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|
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| Primary | Hemoglobin A1c | Glycemic control | Posted | Mean | 95% Confidence Interval | Mean percentage of HbA1c | Month 3 (one month post-intervention) |
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|
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| Primary | Hemoglobin A1c | Glycemic control | Posted | Mean | 95% Confidence Interval | Mean percentage of HbA1c | Month 9 (6 months post-intervention) |
|
|
|
| Secondary | Health-related Quality of Life (SF-12) | The Medical Outcomes Study Short Form Health Survey Version 2 (SF-12). Physical Components Summary (PCS) and Mental Components Summary (MCS) were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life. | Posted | Mean | 95% Confidence Interval | Score on the PCS & MCS subscales (0=100) | Week 0 (Baseline) |
|
|
|
| Secondary | Health-related Quality of Life (SF-12) | Medical Outcomes Study Short Form Health Survey Version 2 (SF-12) Physical Components Summary (PCS) and Mental Components Summary (MCS) scores were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life. | Posted | Mean | 95% Confidence Interval | Scores on PCS & MCS scores (0-100) | Month 2 (post-intervention) |
|
|
|
| Secondary | Health-related Quality of Life (SF-12) | Medical Outcomes Study Short Form Health Survey Version 2 (SF-12) Physical Components Summary (PCS) and Mental Components Summary (MCS) scores were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life. | Posted | Mean | 95% Confidence Interval | scores on PCS & MCS scores (0-100) | Month 3 (one month post-intervention) |
|
|
|
| Secondary | Health-related Quality of Life (SF-12) | The Medical Outcomes Study Short Form Health Survey, the SF-12 PCS and MCS scores were normed ranging from 0-100 with higher scores corresponding to better perceived health-related quality of life | Posted | Mean | 95% Confidence Interval | Scores on PCS & MCS scores (0-100) | Month 9 (6 months post-intervention) |
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|
| 103 |
| 0 |
| 103 |
| 0 |
| 103 |
| EG001 | Attention Control | General health education | 0 | 83 | 0 | 83 | 0 | 83 |
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| D004700 | Endocrine System Diseases |