Trial Outcomes & Findings for Reducing Cardiovascular Disease Risk Factors in Rural Communities in North Carolina (NCT NCT02707432)
NCT ID: NCT02707432
Last Updated: 2020-04-09
Results Overview
Measured in pounds
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
143 participants
Primary outcome timeframe
Baseline and 6 months after initiated treatment
Results posted on
2020-04-09
Participant Flow
Participant milestones
| Measure |
Time 1 Heart Matters Intervention Group
This group will receive the adapted intervention, "Heart Matters" (adapted from the PREMIER intervention) immediately after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period.
|
Time 2 Heart Matters 6 Month-Delayed Intervention Group
This 6 month delayed intervention group will receive the adapted intervention, "Heart Matters," six months after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period.
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
71
|
|
Overall Study
COMPLETED
|
57
|
51
|
|
Overall Study
NOT COMPLETED
|
15
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data were available for 139 participants
Baseline characteristics by cohort
| Measure |
Time 1 Heart Matters Intervention Group
n=72 Participants
This group will receive the adapted intervention, "Heart Matters" (adapted from the PREMIER intervention) immediately after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period.
|
Time 2 Heart Matters 6 Month-Delayed Intervention Group
n=71 Participants
This 6 month delayed intervention group will receive the adapted intervention, "Heart Matters," six months after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period.
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=71 Participants • Data were available for 139 participants
|
0 Participants
n=68 Participants • Data were available for 139 participants
|
0 Participants
n=139 Participants • Data were available for 139 participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=71 Participants • Data were available for 139 participants
|
40 Participants
n=68 Participants • Data were available for 139 participants
|
91 Participants
n=139 Participants • Data were available for 139 participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=71 Participants • Data were available for 139 participants
|
28 Participants
n=68 Participants • Data were available for 139 participants
|
48 Participants
n=139 Participants • Data were available for 139 participants
|
|
Age, Continuous
|
54.38 years
STANDARD_DEVIATION 16.23 • n=71 Participants • Data were available for 139 participants
|
59.93 years
STANDARD_DEVIATION 12.64 • n=68 Participants • Data were available for 139 participants
|
57.26 years
STANDARD_DEVIATION 14.69 • n=139 Participants • Data were available for 139 participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=72 Participants • Data were available for 140 participants
|
47 Participants
n=68 Participants • Data were available for 140 participants
|
101 Participants
n=140 Participants • Data were available for 140 participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=72 Participants • Data were available for 140 participants
|
21 Participants
n=68 Participants • Data were available for 140 participants
|
39 Participants
n=140 Participants • Data were available for 140 participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=72 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=143 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=72 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=143 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=72 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=143 Participants
|
|
Race (NIH/OMB)
Black or African American
|
72 Participants
n=72 Participants
|
71 Participants
n=71 Participants
|
143 Participants
n=143 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=72 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=143 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=72 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=143 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=72 Participants
|
0 Participants
n=71 Participants
|
0 Participants
n=143 Participants
|
|
Region of Enrollment
United States
|
72 Participants
n=72 Participants
|
71 Participants
n=71 Participants
|
143 Participants
n=143 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 months after initiated treatmentPopulation: Data reported only for participants with both Baseline and Month 6 data.
Measured in pounds
Outcome measures
| Measure |
Time 1 Heart Matters Intervention Group
n=37 Participants
This group will receive the adapted intervention, "Heart Matters" (adapted from the PREMIER intervention) immediately after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period.
|
Time 2 Heart Matters 6 Month-Delayed Intervention Group
n=34 Participants
This 6 month delayed intervention group will receive the adapted intervention, "Heart Matters," six months after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period.
|
|---|---|---|
|
Change in Weight
|
0.41 pounds
Standard Deviation 11.23
|
0.92 pounds
Standard Deviation 10.33
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Data reported only for participants with both Baseline and Month 6 data.
Blood pressure as measured in mmHg
Outcome measures
| Measure |
Time 1 Heart Matters Intervention Group
n=38 Participants
This group will receive the adapted intervention, "Heart Matters" (adapted from the PREMIER intervention) immediately after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period.
|
Time 2 Heart Matters 6 Month-Delayed Intervention Group
n=32 Participants
This 6 month delayed intervention group will receive the adapted intervention, "Heart Matters," six months after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period.
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
8.79 mmHg
Standard Deviation 19.42
|
2.67 mmHg
Standard Deviation 18.01
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Data reported only for participants with both Baseline and Month 6 data.
As measured in mmHg
Outcome measures
| Measure |
Time 1 Heart Matters Intervention Group
n=38 Participants
This group will receive the adapted intervention, "Heart Matters" (adapted from the PREMIER intervention) immediately after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period.
|
Time 2 Heart Matters 6 Month-Delayed Intervention Group
n=32 Participants
This 6 month delayed intervention group will receive the adapted intervention, "Heart Matters," six months after baseline data collection. Intervention is 26, 90 minute group sessions and 7, 30-60 minute individual sessions across a 1 year period with 1st 6 months intensive period and 2nd 6 months maintenance period.
|
|---|---|---|
|
Change in Diastolic Blood Pressure
|
5.05 mmHg
Standard Deviation 12.96
|
2.00 mmHg
Standard Deviation 10.93
|
Adverse Events
Time 1 Heart Matters Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Time 2 Heart Matters 6 Month-Delayed Intervention Group
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
Stephanie Hoover, PhD
University of North Carolina at Chapel Hill
Phone: 919-966-1649
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place