Trial Outcomes & Findings for Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study (NCT NCT02835495)
NCT ID: NCT02835495
Last Updated: 2020-09-24
Results Overview
To characterize the ability to recruit Veterans to participate in this pilot study, the proportion of Veterans screened who are eligible to participate and the proportion of eligible participants who agree to participate will be calculated. The rate of referrals to the program by providers in the local community-based outpatient clinic will also be monitored.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
6 months
Results posted on
2020-09-24
Participant Flow
Of 118 enrolled participants, 58 met inclusion criteria. 51 participants were randomized. 1 had to withdraw pre-intervention initiation due to cancer diagnosis. 50 participants were randomized and received the intervention treatment.
Participant milestones
| Measure |
Lifestyle Weight Loss
Behavioral: HELP Vets Intervention
Lifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator
HELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.
|
Enhanced Usual Care
Behavioral: Individual Education Program
Standard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter
Individual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
|
Overall Study
Intervention Start
|
25
|
25
|
|
Overall Study
COMPLETED
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
| Measure |
Lifestyle Weight Loss
Behavioral: HELP Vets Intervention
Lifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator
HELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.
|
Enhanced Usual Care
Behavioral: Individual Education Program
Standard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter
Individual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.
|
|---|---|---|
|
Overall Study
Cancer diagnosis prior intervention
|
1
|
0
|
|
Overall Study
Declined in-person follow-up visit
|
4
|
2
|
Baseline Characteristics
Healthy Living Partnerships to Prevent Diabetes in Veterans Pilot Study
Baseline characteristics by cohort
| Measure |
Lifestyle Weight Loss
n=26 Participants
Behavioral: HELP Vets Intervention
Lifestyle intervention consisting of 24 weekly group meetings led by a Veteran community health worker and 3 individual sessions with a nutritionist/diabetes educator
HELP Vets Intervention: This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.
|
Enhanced Usual Care
n=25 Participants
Behavioral: Individual Education Program
Standard care consisting of 2 individual sessions with a nutritionist/diabetes educator and a monthly newsletter
Individual Education Program: Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 11.5 • n=93 Participants
|
64.2 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
62.1 years
STANDARD_DEVIATION 11.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=93 Participants
|
25 participants
n=4 Participants
|
51 participants
n=27 Participants
|
|
Weight
|
222.8 pounds
STANDARD_DEVIATION 32.6 • n=93 Participants
|
231.9 pounds
STANDARD_DEVIATION 30.5 • n=4 Participants
|
227.3 pounds
STANDARD_DEVIATION 31.6 • n=27 Participants
|
|
Systolic Blood Pressure
|
133.5 mmHg
STANDARD_DEVIATION 14.4 • n=93 Participants
|
132.8 mmHg
STANDARD_DEVIATION 12.4 • n=4 Participants
|
133.2 mmHg
STANDARD_DEVIATION 13.3 • n=27 Participants
|
|
Diastolic Blood Pressure
|
81.0 mmHg
STANDARD_DEVIATION 7.4 • n=93 Participants
|
80.8 mmHg
STANDARD_DEVIATION 7.5 • n=4 Participants
|
80.9 mmHg
STANDARD_DEVIATION 7.4 • n=27 Participants
|
|
Fasting Glucose
|
18 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Cholesterol (Lipid Panel)
|
19 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTo characterize the ability to recruit Veterans to participate in this pilot study, the proportion of Veterans screened who are eligible to participate and the proportion of eligible participants who agree to participate will be calculated. The rate of referrals to the program by providers in the local community-based outpatient clinic will also be monitored.
Outcome measures
| Measure |
Proportion of Eligible Participants of Total Screened
n=118 Participants
This reports the total number of participants who were screened and determined to be eligible for the study.
|
Proportion of Eligible Participants Who Were Randomized
n=58 Participants
This reports the total number of participants who were randomized of those eligible for participation.
|
|---|---|---|
|
Recruitment of Study Participants
|
58 Participants
|
51 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTo characterize the ability to retain Veterans in this pilot study, the percentage of participants who complete the study (attendance at the 6-month assessment visit) as a measure of overall study retention will be calculated.
Outcome measures
| Measure |
Proportion of Eligible Participants of Total Screened
n=25 Participants
This reports the total number of participants who were screened and determined to be eligible for the study.
|
Proportion of Eligible Participants Who Were Randomized
n=25 Participants
This reports the total number of participants who were randomized of those eligible for participation.
|
|---|---|---|
|
Retention of Study Participants
|
21 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants in the Enhanced Usual Care Group were not asked to attend intervention sessions.
The proportion of intervention sessions attended will be calculated.
Outcome measures
| Measure |
Proportion of Eligible Participants of Total Screened
n=25 Participants
This reports the total number of participants who were screened and determined to be eligible for the study.
|
Proportion of Eligible Participants Who Were Randomized
This reports the total number of participants who were randomized of those eligible for participation.
|
|---|---|---|
|
Adherence to the Lifestyle Weight Loss Intervention
|
14 sessions attended
Interval 5.0 to 20.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsThe means and standard deviations at 6 months will be calculated.
Outcome measures
| Measure |
Proportion of Eligible Participants of Total Screened
n=20 Participants
This reports the total number of participants who were screened and determined to be eligible for the study.
|
Proportion of Eligible Participants Who Were Randomized
n=22 Participants
This reports the total number of participants who were randomized of those eligible for participation.
|
|---|---|---|
|
Weight
|
210.4 pounds
Standard Deviation 32.4
|
229.5 pounds
Standard Deviation 34.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsThe means and standard deviations at 6 months will be calculated.
Outcome measures
| Measure |
Proportion of Eligible Participants of Total Screened
n=20 Participants
This reports the total number of participants who were screened and determined to be eligible for the study.
|
Proportion of Eligible Participants Who Were Randomized
n=22 Participants
This reports the total number of participants who were randomized of those eligible for participation.
|
|---|---|---|
|
Systolic Blood Pressure
|
133.4 mmHg
Standard Deviation 14.1
|
133.8 mmHg
Standard Deviation 13.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsThe means and standard deviations at 6 months will be calculated.
Outcome measures
| Measure |
Proportion of Eligible Participants of Total Screened
n=20 Participants
This reports the total number of participants who were screened and determined to be eligible for the study.
|
Proportion of Eligible Participants Who Were Randomized
n=22 Participants
This reports the total number of participants who were randomized of those eligible for participation.
|
|---|---|---|
|
Diastolic Blood Pressure
|
79.9 mmHg
Standard Deviation 11.6
|
82.3 mmHg
Standard Deviation 8.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsIn order to assess the feasibility of collecting this data from the medical record, the proportion of participants for whom this data is available at 6-months post-randomization (+/- 90 days) will be reported.
Outcome measures
| Measure |
Proportion of Eligible Participants of Total Screened
n=25 Participants
This reports the total number of participants who were screened and determined to be eligible for the study.
|
Proportion of Eligible Participants Who Were Randomized
n=25 Participants
This reports the total number of participants who were randomized of those eligible for participation.
|
|---|---|---|
|
Proportion of Participants for Whom Fasting Glucose is Available at 6-months Post-randomization
|
22 Participants
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsIn order to assess the feasibility of collecting this data from the medical record, the proportion of participants for whom this data is available at 6-months post-randomization (+/- 90 days) will be reported.
Outcome measures
| Measure |
Proportion of Eligible Participants of Total Screened
n=25 Participants
This reports the total number of participants who were screened and determined to be eligible for the study.
|
Proportion of Eligible Participants Who Were Randomized
n=25 Participants
This reports the total number of participants who were randomized of those eligible for participation.
|
|---|---|---|
|
Proportion of Participants for Whom Cholesterol (Lipid Panel) is Available at 6-months Post-randomization
|
17 Participants
|
19 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Data not collected
The means and standard deviations at 6 months will be calculated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Data not collected
The means and standard deviations at 6 months will be calculated.
Outcome measures
Outcome data not reported
Adverse Events
Lifestyle Weight Loss
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Usual Care
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
Mara Z. Vitolins, DrPH, MPH, RDN
Wake Forest School of Medicine
Phone: (336) 716-2886
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place