Trial Outcomes & Findings for A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community (NCT NCT02114814)
NCT ID: NCT02114814
Last Updated: 2022-05-24
Results Overview
Glycemic control in %.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
186 participants
Primary outcome timeframe
Week 0 (Baseline)
Results posted on
2022-05-24
Participant Flow
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.
Participant milestones
| Measure |
Intervention
A Family-Based Diabetes Self-Management Intervention
|
Attention Control
General Health Education
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
83
|
|
Overall Study
COMPLETED
|
88
|
74
|
|
Overall Study
NOT COMPLETED
|
15
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community
Baseline characteristics by cohort
| Measure |
Family-based Diabetes Intervention
n=103 Participants
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.
|
Attention Control
n=83 Participants
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.
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
94 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
103 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
30.9 kg/m2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
31.6 kg/m2
STANDARD_DEVIATION 4.6 • n=7 Participants
|
31.2 kg/m2
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Systolic Blood pressure
|
128.6 mmHg
STANDARD_DEVIATION 18.3 • n=5 Participants
|
133.1 mmHg
STANDARD_DEVIATION 11.0 • n=7 Participants
|
130.6 mmHg
STANDARD_DEVIATION 15.6 • n=5 Participants
|
|
Physical Activity (the Short International Physical Activity Questionnaire)
|
4983.1 MET min/week
STANDARD_DEVIATION 6906.2 • n=5 Participants
|
3932.0 MET min/week
STANDARD_DEVIATION 5871.2 • n=7 Participants
|
4514.9 MET min/week
STANDARD_DEVIATION 6425.5 • n=5 Participants
|
|
Dietary Intake ( BFRSS fruits/vegetables) servings/day
|
2.6 servings/day
STANDARD_DEVIATION 0.4 • n=5 Participants
|
2.7 servings/day
STANDARD_DEVIATION 0.4 • n=7 Participants
|
2.6 servings/day
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Family Support (Supportive Resources (CIRS))
|
1.4 scores on a scale
STANDARD_DEVIATION 0.3 • n=5 Participants
|
1.7 scores on a scale
STANDARD_DEVIATION 0.4 • n=7 Participants
|
1.6 scores on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Diabetes self-efficacy (DSE)
|
6.4 scores on a scale
STANDARD_DEVIATION 1.8 • n=5 Participants
|
6.8 scores on a scale
STANDARD_DEVIATION 2.4 • n=7 Participants
|
6.6 scores on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Diabetes self-management (Revised Summary of Diabetes Self-Care Activities)
Diabetes self-management: Diet
|
3.0 days/week
STANDARD_DEVIATION 1.5 • n=5 Participants
|
3.2 days/week
STANDARD_DEVIATION 1.4 • n=7 Participants
|
3.1 days/week
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Diabetes self-management (Revised Summary of Diabetes Self-Care Activities)
Diabetes self-management:General diet
|
3.0 days/week
STANDARD_DEVIATION 1.9 • n=5 Participants
|
3.3 days/week
STANDARD_DEVIATION 2.1 • n=7 Participants
|
3.1 days/week
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Diabetes self-management (Revised Summary of Diabetes Self-Care Activities)
Diabetes self-management: Blood glucose
|
1.8 days/week
STANDARD_DEVIATION 2.3 • n=5 Participants
|
1.7 days/week
STANDARD_DEVIATION 2.1 • n=7 Participants
|
1.7 days/week
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Diabetes self-management (Revised Summary of Diabetes Self-Care Activities)
Diabetes self-management: Foot check
|
2.6 days/week
STANDARD_DEVIATION 2.4 • n=5 Participants
|
4.1 days/week
STANDARD_DEVIATION 2.5 • n=7 Participants
|
3.3 days/week
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Diabetes self-management (Revised Summary of Diabetes Self-Care Activities)
Diabetes self-management: Medication
|
6.1 days/week
STANDARD_DEVIATION 2.1 • n=5 Participants
|
6.6 days/week
STANDARD_DEVIATION 1.3 • n=7 Participants
|
6.3 days/week
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Diabetes knowledge (Spoken Knowledge of Diabetes in Low Literacy Patients with Diabetes )
|
2.9 scores on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
4.2 scores on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
3.5 scores on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Medical Outcomes Study Short Form Health Survey Version 2 (SF-12v2)
SF-12v2 PCS
|
48.9 scores on a scale
STANDARD_DEVIATION 9.2 • n=5 Participants
|
47.5 scores on a scale
STANDARD_DEVIATION 7.7 • n=7 Participants
|
48.3 scores on a scale
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Medical Outcomes Study Short Form Health Survey Version 2 (SF-12v2)
SF-12v2 MCS
|
45.9 scores on a scale
STANDARD_DEVIATION 10.2 • n=5 Participants
|
50.2 scores on a scale
STANDARD_DEVIATION 12.7 • n=7 Participants
|
47.8 scores on a scale
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
HbA1c
|
8.5 percent
STANDARD_DEVIATION 2.1 • n=5 Participants
|
9.5 percent
STANDARD_DEVIATION 2.0 • n=7 Participants
|
8.9 percent
STANDARD_DEVIATION 2.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0 (Baseline)Population: Hispanic adults with type 2 diabetes and their family members
Glycemic control in %.
Outcome measures
| Measure |
Intervention
n=103 Participants
Diabetes Self-Management
|
Attention Control
n=83 Participants
General Health education
|
|---|---|---|
|
Hemoglobin A1C
|
8.5 mean percentage of HbA1c
Interval 7.9 to 9.1
|
9.4 mean percentage of HbA1c
Interval 8.3 to 10.1
|
PRIMARY outcome
Timeframe: Month 2 (post-intervention)Glycemic control
Outcome measures
| Measure |
Intervention
n=90 Participants
Diabetes Self-Management
|
Attention Control
n=78 Participants
General Health education
|
|---|---|---|
|
Hemoglobin A1c
|
7.7 percentage of HbA1c
Interval 7.1 to 8.2
|
8.7 percentage of HbA1c
Interval 8.1 to 9.3
|
PRIMARY outcome
Timeframe: Month 3 (one month post-intervention)Glycemic control
Outcome measures
| Measure |
Intervention
n=88 Participants
Diabetes Self-Management
|
Attention Control
n=74 Participants
General Health education
|
|---|---|---|
|
Hemoglobin A1c
|
7.7 Mean percentage of HbA1c
Interval 7.1 to 8.3
|
9.0 Mean percentage of HbA1c
Interval 8.3 to 9.6
|
PRIMARY outcome
Timeframe: Month 9 (6 months post-intervention)Glycemic control
Outcome measures
| Measure |
Intervention
n=82 Participants
Diabetes Self-Management
|
Attention Control
n=67 Participants
General Health education
|
|---|---|---|
|
Hemoglobin A1c
|
8.4 Mean percentage of HbA1c
Interval 7.8 to 9.0
|
8.2 Mean percentage of HbA1c
Interval 7.7 to 8.8
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intervention
n=100 Participants
Diabetes Self-Management
|
Attention Control
n=80 Participants
General Health education
|
|---|---|---|
|
Health-related Quality of Life (SF-12)
SF-12 Mental Health (MCS)
|
47.2 Score on the PCS & MCS subscales (0=100)
Interval 44.7 to 49.8
|
50.0 Score on the PCS & MCS subscales (0=100)
Interval 46.8 to 53.3
|
|
Health-related Quality of Life (SF-12)
SF-12 Physical Health (PCS)
|
49.5 Score on the PCS & MCS subscales (0=100)
Interval 47.2 to 51.8
|
49.1 Score on the PCS & MCS subscales (0=100)
Interval 46.9 to 51.3
|
SECONDARY outcome
Timeframe: Month 2 (post-intervention)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.
Outcome measures
| Measure |
Intervention
n=90 Participants
Diabetes Self-Management
|
Attention Control
n=78 Participants
General Health education
|
|---|---|---|
|
Health-related Quality of Life (SF-12)
SF-12 Physical Health (PCS)
|
50.6 Scores on PCS & MCS scores (0-100)
Interval 48.8 to 52.4
|
49.5 Scores on PCS & MCS scores (0-100)
Interval 47.4 to 51.5
|
|
Health-related Quality of Life (SF-12)
SF-12 Mental Health (MCS)
|
47.7 Scores on PCS & MCS scores (0-100)
Interval 45.3 to 50.1
|
51.7 Scores on PCS & MCS scores (0-100)
Interval 49.1 to 54.4
|
SECONDARY outcome
Timeframe: Month 3 (one month post-intervention)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.
Outcome measures
| Measure |
Intervention
n=88 Participants
Diabetes Self-Management
|
Attention Control
n=74 Participants
General Health education
|
|---|---|---|
|
Health-related Quality of Life (SF-12)
SF-12 Physical Health (PCS)
|
51.1 scores on PCS & MCS scores (0-100)
Interval 49.4 to 52.8
|
49.6 scores on PCS & MCS scores (0-100)
Interval 47.5 to 51.7
|
|
Health-related Quality of Life (SF-12)
SF-12 Mental Health (MCS)
|
47.9 scores on PCS & MCS scores (0-100)
Interval 45.5 to 50.4
|
52.4 scores on PCS & MCS scores (0-100)
Interval 49.8 to 55.0
|
SECONDARY outcome
Timeframe: Month 9 (6 months post-intervention)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
Outcome measures
| Measure |
Intervention
n=82 Participants
Diabetes Self-Management
|
Attention Control
n=67 Participants
General Health education
|
|---|---|---|
|
Health-related Quality of Life (SF-12)
SF-12 Physical Components Summary (PCS)
|
53.3 Scores on PCS & MCS scores (0-100)
Interval 51.4 to 55.1
|
50.3 Scores on PCS & MCS scores (0-100)
Interval 47.2 to 53.5
|
|
Health-related Quality of Life (SF-12)
SF-12 Mental Components Summary (MCS)
|
48.9 Scores on PCS & MCS scores (0-100)
Interval 45.9 to 52.0
|
55.7 Scores on PCS & MCS scores (0-100)
Interval 52.0 to 59.4
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place