Trial Outcomes & Findings for Augmented Care at Worksite for Diabetes Prevention (NCT NCT03382873)
NCT ID: NCT03382873
Last Updated: 2024-04-11
Results Overview
Change in weight as measured in light clothing and shoes removed
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
208 participants
Primary outcome timeframe
baseline and 4-months
Results posted on
2024-04-11
Participant Flow
Employees from a Midwestern university with overweight or obesity and prediabetes were recruited from 2018-2021.
Participants completed 4 weeks of the standard Group Lifestyle Balance (GLB) intervention. Those who achieved \>2.5% weight loss at week 5 remained in GLB at week 5. Those who achieved \<2.5% weight loss at week 5 were stratified to the GLB Plus (GLB+) intervention at week 5. Participants were paired based on percent weight change at month 5. Each member in the pair was randomized to group at month 5 for the study duration. Thus, group sample sizes are different at month 5 compared to month 4.
Participant milestones
| Measure |
Group Lifestyle Balance (GLB)
Standard lifestyle intervention
|
Group Lifestyle Balance Plus (GLB+)
Augmented lifestyle intervention for slow responders
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
122
|
|
Overall Study
Completed 4-months
|
80
|
111
|
|
Overall Study
Randomized at 5-months
|
94
|
96
|
|
Overall Study
Completed 12-months
|
87
|
88
|
|
Overall Study
Completed 18-months
|
55
|
60
|
|
Overall Study
COMPLETED
|
55
|
60
|
|
Overall Study
NOT COMPLETED
|
31
|
62
|
Reasons for withdrawal
| Measure |
Group Lifestyle Balance (GLB)
Standard lifestyle intervention
|
Group Lifestyle Balance Plus (GLB+)
Augmented lifestyle intervention for slow responders
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
10
|
|
Overall Study
Withdrawal by Subject
|
6
|
11
|
|
Overall Study
Visit not completed due to pandemic
|
16
|
41
|
Baseline Characteristics
Augmented Care at Worksite for Diabetes Prevention
Baseline characteristics by cohort
| Measure |
Group Lifestyle Balance (GLB)
n=80 Participants
Standard lifestyle intervention
|
Group Lifestyle Balance Plus (GLB+)
n=111 Participants
Augmented lifestyle intervention for slow responders
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
52.1 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Body weight
|
102.6 kg
STANDARD_DEVIATION 2.7 • n=5 Participants
|
102.5 kg
STANDARD_DEVIATION 2.3 • n=7 Participants
|
102.5 kg
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Fasting glucose
|
109.24 mg/dL
STANDARD_DEVIATION 1.14 • n=5 Participants
|
107.58 mg/dL
STANDARD_DEVIATION 0.99 • n=7 Participants
|
108.1 mg/dL
STANDARD_DEVIATION 0.71 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 4-monthsChange in weight as measured in light clothing and shoes removed
Outcome measures
| Measure |
Group Lifestyle Balance (GLB)
n=80 Participants
Standard lifestyle intervention
|
Group Lifestyle Balance Plus (GLB+)
n=111 Participants
Augmented lifestyle intervention for slow responders
|
|---|---|---|
|
Percent Weight Change
|
-8.13 percent change
Standard Error 0.48
|
-3.46 percent change
Standard Error 0.31
|
PRIMARY outcome
Timeframe: baseline and 12-monthsPopulation: Compares the change for the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest at 12-months)
Change in weight as measured in light clothing and shoes removed
Outcome measures
| Measure |
Group Lifestyle Balance (GLB)
n=47 Participants
Standard lifestyle intervention
|
Group Lifestyle Balance Plus (GLB+)
n=59 Participants
Augmented lifestyle intervention for slow responders
|
|---|---|---|
|
Percent Weight Change
|
-9.55 percent change
Standard Error 0.96
|
-4.00 percent change
Standard Error 1.05
|
PRIMARY outcome
Timeframe: 12-months and 18-monthsPopulation: Compares the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest at 18-months for weight loss maintenance)
Change in weight as measured in light clothing and shoes removed
Outcome measures
| Measure |
Group Lifestyle Balance (GLB)
n=27 Participants
Standard lifestyle intervention
|
Group Lifestyle Balance Plus (GLB+)
n=42 Participants
Augmented lifestyle intervention for slow responders
|
|---|---|---|
|
Percent Weight Change
|
2.22 percent change
Standard Error 0.59
|
2.28 percent change
Standard Error 0.56
|
SECONDARY outcome
Timeframe: baseline and 4-monthsFasting glucose from a fingerstick sample
Outcome measures
| Measure |
Group Lifestyle Balance (GLB)
n=80 Participants
Standard lifestyle intervention
|
Group Lifestyle Balance Plus (GLB+)
n=111 Participants
Augmented lifestyle intervention for slow responders
|
|---|---|---|
|
Fasting Glucose
|
-7.01 mg/dL
Standard Error 1.13
|
-3.18 mg/dL
Standard Error 0.98
|
SECONDARY outcome
Timeframe: baseline and 12-monthsPopulation: Compares the GLB/GLB intervention sequence to GLB+/GLB+ intervention sequence (the primary comparison of interest at 12-months)
Fasting glucose from a fingerstick sample
Outcome measures
| Measure |
Group Lifestyle Balance (GLB)
n=47 Participants
Standard lifestyle intervention
|
Group Lifestyle Balance Plus (GLB+)
n=59 Participants
Augmented lifestyle intervention for slow responders
|
|---|---|---|
|
Fasting Glucose
|
-4.30 mg/dL
Standard Error 1.57
|
-4.04 mg/dL
Standard Error 1.70
|
SECONDARY outcome
Timeframe: 12-months and 18-monthsPopulation: Compares the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest at 18-months)
Fasting glucose from a fingerstick sample
Outcome measures
| Measure |
Group Lifestyle Balance (GLB)
n=27 Participants
Standard lifestyle intervention
|
Group Lifestyle Balance Plus (GLB+)
n=42 Participants
Augmented lifestyle intervention for slow responders
|
|---|---|---|
|
Fasting Glucose
|
-1.21 mg/dL
Standard Error 2.28
|
2.71 mg/dL
Standard Error 2.08
|
Adverse Events
Group Lifestyle Balance (GLB)
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Group Lifestyle Balance Plus (GLB+)
Serious events: 3 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group Lifestyle Balance (GLB)
n=86 participants at risk
Standard lifestyle intervention
|
Group Lifestyle Balance Plus (GLB+)
n=122 participants at risk
Augmented lifestyle intervention for slow responders
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hamstring tear
|
0.00%
0/86 • 18 months
Adverse events were collected at every participant contact using a standardized form.
|
0.82%
1/122 • Number of events 1 • 18 months
Adverse events were collected at every participant contact using a standardized form.
|
|
Surgical and medical procedures
Hip replacement
|
0.00%
0/86 • 18 months
Adverse events were collected at every participant contact using a standardized form.
|
0.82%
1/122 • Number of events 1 • 18 months
Adverse events were collected at every participant contact using a standardized form.
|
|
Congenital, familial and genetic disorders
Arrythmia
|
0.00%
0/86 • 18 months
Adverse events were collected at every participant contact using a standardized form.
|
0.82%
1/122 • Number of events 1 • 18 months
Adverse events were collected at every participant contact using a standardized form.
|
|
Gastrointestinal disorders
Colon abscess
|
1.2%
1/86 • Number of events 1 • 18 months
Adverse events were collected at every participant contact using a standardized form.
|
0.00%
0/122 • 18 months
Adverse events were collected at every participant contact using a standardized form.
|
|
Surgical and medical procedures
Hand surgery
|
1.2%
1/86 • Number of events 1 • 18 months
Adverse events were collected at every participant contact using a standardized form.
|
0.00%
0/122 • 18 months
Adverse events were collected at every participant contact using a standardized form.
|
Other adverse events
| Measure |
Group Lifestyle Balance (GLB)
n=86 participants at risk
Standard lifestyle intervention
|
Group Lifestyle Balance Plus (GLB+)
n=122 participants at risk
Augmented lifestyle intervention for slow responders
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle soreness
|
2.3%
2/86 • Number of events 2 • 18 months
Adverse events were collected at every participant contact using a standardized form.
|
6.6%
8/122 • Number of events 8 • 18 months
Adverse events were collected at every participant contact using a standardized form.
|
|
Musculoskeletal and connective tissue disorders
Knee or hip pain
|
4.7%
4/86 • Number of events 4 • 18 months
Adverse events were collected at every participant contact using a standardized form.
|
4.1%
5/122 • Number of events 5 • 18 months
Adverse events were collected at every participant contact using a standardized form.
|
Additional Information
Dr. Carla Miller (current affiliation)
Indiana University
Phone: 812-855-1608
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place