Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 Diabetes, Hispanic adults, Diabetes self-management, Family-based intervention
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALDiabetes self-management program for Hispanics and their families
The intervention group received an 8-weekly culturally tailored diabetes self-management and family support education program delivered in Spanish
BEHAVIORALGeneral health educational program for Hispanics and their families
The attention control group received 8-weekly education program on general health information
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
University of North Carolina, Greensboro
Ohio State University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
for participants: 1. Community-dwelling 2. Self-identification as Hispanic 3. Age 18 years or older 4. Self-identification as having a medical diagnosis of type 2 diabetes 5. An adult family member willing to participate in the study. 6. Must be able to speak either English or Spanish Inclusion criteria for family members/relatives are: 1. Family member is over 18 2. Reside in the same household as the participant with diabetes 3. Must be able to speak either English or Spanish
Exclusion criteria
We will exclude Hispanic adults and family members who are: 1. diagnosed with type 1 diabetes 2. report prior (within the past year) or current participation in other diabetes self-management intervention programs 3. cognitively impaired (not oriented to time, place, or person, or with known dementia) 4. Pregnant at the time of T1 (baseline) data collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C | Week 0 (Baseline) | Glycemic control in %. |
| Hemoglobin A1c | Month 2 (post-intervention) | Glycemic control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life (SF-12) | Week 0 (Baseline) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 103 |
| Attention Control 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. | 83 |
| Total | 186 |
Baseline characteristics
| Characteristic | Family-based Diabetes Intervention | Attention Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 3 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 94 Participants | 80 Participants | 174 Participants |
| Body Mass Index (BMI) | 30.9 kg/m2 STANDARD_DEVIATION 5.7 | 31.6 kg/m2 STANDARD_DEVIATION 4.6 | 31.2 kg/m2 STANDARD_DEVIATION 5.2 |
| Diabetes knowledge (Spoken Knowledge of Diabetes in Low Literacy Patients with Diabetes ) | 2.9 scores on a scale STANDARD_DEVIATION 2.5 | 4.2 scores on a scale STANDARD_DEVIATION 2.2 | 3.5 scores on a scale STANDARD_DEVIATION 2.4 |
| Diabetes self-efficacy (DSE) | 6.4 scores on a scale STANDARD_DEVIATION 1.8 | 6.8 scores on a scale STANDARD_DEVIATION 2.4 | 6.6 scores on a scale STANDARD_DEVIATION 2.1 |
| Diabetes self-management (Revised Summary of Diabetes Self-Care Activities) Diabetes self-management: Blood glucose | 1.8 days/week STANDARD_DEVIATION 2.3 | 1.7 days/week STANDARD_DEVIATION 2.1 | 1.7 days/week STANDARD_DEVIATION 2.3 |
| Diabetes self-management (Revised Summary of Diabetes Self-Care Activities) Diabetes self-management: Diet | 3.0 days/week STANDARD_DEVIATION 1.5 | 3.2 days/week STANDARD_DEVIATION 1.4 | 3.1 days/week STANDARD_DEVIATION 1.4 |
| Diabetes self-management (Revised Summary of Diabetes Self-Care Activities) Diabetes self-management: Foot check | 2.6 days/week STANDARD_DEVIATION 2.4 | 4.1 days/week STANDARD_DEVIATION 2.5 | 3.3 days/week STANDARD_DEVIATION 2.5 |
| Diabetes self-management (Revised Summary of Diabetes Self-Care Activities) Diabetes self-management:General diet | 3.0 days/week STANDARD_DEVIATION 1.9 | 3.3 days/week STANDARD_DEVIATION 2.1 | 3.1 days/week STANDARD_DEVIATION 2 |
| Diabetes self-management (Revised Summary of Diabetes Self-Care Activities) Diabetes self-management: Medication | 6.1 days/week STANDARD_DEVIATION 2.1 | 6.6 days/week STANDARD_DEVIATION 1.3 | 6.3 days/week STANDARD_DEVIATION 1.8 |
| Dietary Intake ( BFRSS fruits/vegetables) servings/day | 2.6 servings/day STANDARD_DEVIATION 0.4 | 2.7 servings/day STANDARD_DEVIATION 0.4 | 2.6 servings/day STANDARD_DEVIATION 0.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 103 Participants | 83 Participants | 186 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Family Support (Supportive Resources (CIRS)) | 1.4 scores on a scale STANDARD_DEVIATION 0.3 | 1.7 scores on a scale STANDARD_DEVIATION 0.4 | 1.6 scores on a scale STANDARD_DEVIATION 0.4 |
| HbA1c | 8.5 percent STANDARD_DEVIATION 2.1 | 9.5 percent STANDARD_DEVIATION 2 | 8.9 percent STANDARD_DEVIATION 2.1 |
| Medical Outcomes Study Short Form Health Survey Version 2 (SF-12v2) SF-12v2 MCS | 45.9 scores on a scale STANDARD_DEVIATION 10.2 | 50.2 scores on a scale STANDARD_DEVIATION 12.7 | 47.8 scores on a scale STANDARD_DEVIATION 11.5 |
| Medical Outcomes Study Short Form Health Survey Version 2 (SF-12v2) SF-12v2 PCS | 48.9 scores on a scale STANDARD_DEVIATION 9.2 | 47.5 scores on a scale STANDARD_DEVIATION 7.7 | 48.3 scores on a scale STANDARD_DEVIATION 8.6 |
| Physical Activity (the Short International Physical Activity Questionnaire) | 4983.1 MET min/week STANDARD_DEVIATION 6906.2 | 3932.0 MET min/week STANDARD_DEVIATION 5871.2 | 4514.9 MET min/week STANDARD_DEVIATION 6425.5 |
| Sex: Female, Male Female | 65 Participants | 53 Participants | 118 Participants |
| Sex: Female, Male Male | 38 Participants | 30 Participants | 68 Participants |
| Systolic Blood pressure | 128.6 mmHg STANDARD_DEVIATION 18.3 | 133.1 mmHg STANDARD_DEVIATION 11 | 130.6 mmHg STANDARD_DEVIATION 15.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 83 |
| other Total, other adverse events | 0 / 103 | 0 / 83 |
| serious Total, serious adverse events | 0 / 103 | 0 / 83 |
Outcome results
Primary
Hemoglobin A1c
Glycemic control
Time frame: Month 3 (one month post-intervention)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Hemoglobin A1c | 7.7 Mean percentage of HbA1c |
| Attention Control | Hemoglobin A1c | 9.0 Mean percentage of HbA1c |
Primary
Hemoglobin A1c
Glycemic control
Time frame: Month 9 (6 months post-intervention)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Hemoglobin A1c | 8.4 Mean percentage of HbA1c |
| Attention Control | Hemoglobin A1c | 8.2 Mean percentage of HbA1c |
Primary
Hemoglobin A1c
Glycemic control
Time frame: Month 2 (post-intervention)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Hemoglobin A1c | 7.7 percentage of HbA1c |
| Attention Control | Hemoglobin A1c | 8.7 percentage of HbA1c |
Primary
Hemoglobin A1C
Glycemic control in %.
Time frame: Week 0 (Baseline)
Population: Hispanic adults with type 2 diabetes and their family members
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Hemoglobin A1C | 8.5 mean percentage of HbA1c |
| Attention Control | Hemoglobin A1C | 9.4 mean percentage of HbA1c |
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
Time frame: Month 9 (6 months post-intervention)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Health-related Quality of Life (SF-12) | SF-12 Physical Components Summary (PCS) | 53.3 Scores on PCS & MCS scores (0-100) |
| Intervention | Health-related Quality of Life (SF-12) | SF-12 Mental Components Summary (MCS) | 48.9 Scores on PCS & MCS scores (0-100) |
| Attention Control | Health-related Quality of Life (SF-12) | SF-12 Physical Components Summary (PCS) | 50.3 Scores on PCS & MCS scores (0-100) |
| Attention Control | Health-related Quality of Life (SF-12) | SF-12 Mental Components Summary (MCS) | 55.7 Scores on PCS & MCS scores (0-100) |
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.
Time frame: Month 2 (post-intervention)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Health-related Quality of Life (SF-12) | SF-12 Physical Health (PCS) | 50.6 Scores on PCS & MCS scores (0-100) |
| Intervention | Health-related Quality of Life (SF-12) | SF-12 Mental Health (MCS) | 47.7 Scores on PCS & MCS scores (0-100) |
| Attention Control | Health-related Quality of Life (SF-12) | SF-12 Physical Health (PCS) | 49.5 Scores on PCS & MCS scores (0-100) |
| Attention Control | Health-related Quality of Life (SF-12) | SF-12 Mental Health (MCS) | 51.7 Scores on PCS & MCS scores (0-100) |
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.
Time frame: Month 3 (one month post-intervention)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Health-related Quality of Life (SF-12) | SF-12 Physical Health (PCS) | 51.1 scores on PCS & MCS scores (0-100) |
| Intervention | Health-related Quality of Life (SF-12) | SF-12 Mental Health (MCS) | 47.9 scores on PCS & MCS scores (0-100) |
| Attention Control | Health-related Quality of Life (SF-12) | SF-12 Physical Health (PCS) | 49.6 scores on PCS & MCS scores (0-100) |
| Attention Control | Health-related Quality of Life (SF-12) | SF-12 Mental Health (MCS) | 52.4 scores on PCS & MCS scores (0-100) |
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.
Time frame: Week 0 (Baseline)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Health-related Quality of Life (SF-12) | SF-12 Mental Health (MCS) | 47.2 Score on the PCS & MCS subscales (0=100) |
| Intervention | Health-related Quality of Life (SF-12) | SF-12 Physical Health (PCS) | 49.5 Score on the PCS & MCS subscales (0=100) |
| Attention Control | Health-related Quality of Life (SF-12) | SF-12 Mental Health (MCS) | 50.0 Score on the PCS & MCS subscales (0=100) |
| Attention Control | Health-related Quality of Life (SF-12) | SF-12 Physical Health (PCS) | 49.1 Score on the PCS & MCS subscales (0=100) |