PreDiabetes
Conditions
Keywords
Hyperglycemia, Obese, Overweight
Brief summary
The purpose of the study was to evaluate the impact of augmented care at the worksite through a lifestyle intervention for diabetes prevention among employees with prediabetes who were slower to respond to a standard diabetes prevention intervention.
Detailed description
Employees at the Ohio State University (OSU) with prediabetes participated in a standard lifestyle intervention (Group Lifestyle Balance) for diabetes prevention. Participants who did not achieve \>2.5% weight loss at week 5 of the intervention were stratified to the augmented intervention (Group Lifestyle Balance Plus) at week 5. The impact of the augmented intervention compared to the standard intervention was determined at 4, 12 and 18 months from baseline to determine if implementing early enhanced training helped participants achieve and maintain weight loss similar to those who received the standard intervention.
Interventions
BEHAVIORALGroup Lifestyle Balance (GLB)
The intervention included the following key features: group-based sessions led by a lifestyle coach; a structured, state-of-the-art, 16-session core-curriculum that emphasized behavioral self-management strategies for weight loss and physical activity; 8-months of extended care with bimonthly or monthly sessions; self-monitoring of diet and physical activity.
BEHAVIORALGroup Lifestyle Balance Plus (GLB+)
The GLB+ intervention arm included participants who did not achieve the targeted percent weight loss by week 5 and incorporated enhanced training in values clarification, mindful decision making, planning, and problem solving. GLB+ included the same number of group-based sessions as GLB.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The proposed translational study applied an innovative experimental approach, an adaptive design, to optimize treatment for weight loss and weight loss maintenance in individuals with prediabetes. All participants initiated a standard lifestyle intervention to promote weight loss. Those who did not achieve \>2.5% weight loss during the first month of the intervention were stratified to augmented care to enhance weight loss during the intensive intervention phase. Following the intensive phase, participants were randomly assigned to either the standard intervention or the enhanced intervention for the maintenance study phase. By randomly assigning participants to either the standard maintenance phase of the intervention or the innovative maintenance phase of the intervention following the initial core phase, the impact of extended training in self-regulation for weight loss maintenance was evaluated.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Benefits-eligible Ohio State University (OSU) employee 2. Intend to be employed by OSU through the length of the follow-up phase 3. Body mass index: \>24 kg/m\^2 non-Asians; \>22 kg/m\^2 Asians 4. Fasting blood glucose of 100-125 mg/dL or an A1c of 5.7-6.4% 5. Blood glucose of 110-199 (if non-fasting in previous 2 hours)
Exclusion criteria
1. Blood glucose level of ≥ 200 mg/dL 2. Conditions that would limit adoption of light/moderate physical activity (i.e., cardiac event, severe chronic obstructive pulmonary disease, advanced arthritis, poorly controlled hypertension) 3. Chronic use of medications that affect blood glucose levels (i.e., corticosteroids) 4. Concurrent participation in a structured weight loss program or counseling for bariatric surgery 5. Pregnant or breastfeeding 6. Score of ≥ 10 on the Patient Health Questionnaire-8 indicating moderate to severe depressive symptoms 7. Score of ≥ 27 on the Binge Eating Scale indicating the potential for binge eating 8. Unwilling to accept randomization 9. Planning to move from the area or changing employment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Weight Change | baseline and 4-months | Change in weight as measured in light clothing and shoes removed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Glucose | baseline and 4-months | Fasting glucose from a fingerstick sample |
Countries
United States
Participant flow
Recruitment details
Employees from a Midwestern university with overweight or obesity and prediabetes were recruited from 2018-2021.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Group Lifestyle Balance (GLB) Standard lifestyle intervention | 80 |
| Group Lifestyle Balance Plus (GLB+) Augmented lifestyle intervention for slow responders | 111 |
| Total | 191 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 10 |
| Overall Study | Visit not completed due to pandemic | 16 | 41 |
| Overall Study | Withdrawal by Subject | 6 | 11 |
Baseline characteristics
| Characteristic | Total | Group Lifestyle Balance Plus (GLB+) | Group Lifestyle Balance (GLB) |
|---|---|---|---|
| Age, Continuous | 52.1 years STANDARD_DEVIATION 10.1 | 51.5 years STANDARD_DEVIATION 10.2 | 52.7 years STANDARD_DEVIATION 10 |
| Body weight | 102.5 kg STANDARD_DEVIATION 1.8 | 102.5 kg STANDARD_DEVIATION 2.3 | 102.6 kg STANDARD_DEVIATION 2.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 184 Participants | 105 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Fasting glucose | 108.1 mg/dL STANDARD_DEVIATION 0.71 | 107.58 mg/dL STANDARD_DEVIATION 0.99 | 109.24 mg/dL STANDARD_DEVIATION 1.14 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 18 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 151 Participants | 81 Participants | 70 Participants |
| Sex: Female, Male Female | 140 Participants | 90 Participants | 50 Participants |
| Sex: Female, Male Male | 51 Participants | 21 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 1 / 122 |
| other Total, other adverse events | 4 / 86 | 13 / 122 |
| serious Total, serious adverse events | 2 / 86 | 3 / 122 |
Outcome results
Primary
Percent Weight Change
Change in weight as measured in light clothing and shoes removed
Time frame: baseline and 4-months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group Lifestyle Balance (GLB) | Percent Weight Change | -8.13 percent change | Standard Error 0.48 |
| Group Lifestyle Balance Plus (GLB+) | Percent Weight Change | -3.46 percent change | Standard Error 0.31 |
p-value: <0.0001ANOVA
Primary
Percent Weight Change
Change in weight as measured in light clothing and shoes removed
Time frame: baseline and 12-months
Population: Compares the change for the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest at 12-months)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group Lifestyle Balance (GLB) | Percent Weight Change | -9.55 percent change | Standard Error 0.96 |
| Group Lifestyle Balance Plus (GLB+) | Percent Weight Change | -4.00 percent change | Standard Error 1.05 |
Comparison: Compares the change for the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest)p-value: 0.0001ANOVA
Primary
Percent Weight Change
Change in weight as measured in light clothing and shoes removed
Time frame: 12-months and 18-months
Population: Compares the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest at 18-months for weight loss maintenance)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group Lifestyle Balance (GLB) | Percent Weight Change | 2.22 percent change | Standard Error 0.59 |
| Group Lifestyle Balance Plus (GLB+) | Percent Weight Change | 2.28 percent change | Standard Error 0.56 |
Comparison: Comparison of the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest).p-value: 0.9476ANOVA
Secondary
Fasting Glucose
Fasting glucose from a fingerstick sample
Time frame: baseline and 4-months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group Lifestyle Balance (GLB) | Fasting Glucose | -7.01 mg/dL | Standard Error 1.13 |
| Group Lifestyle Balance Plus (GLB+) | Fasting Glucose | -3.18 mg/dL | Standard Error 0.98 |
p-value: 0.0112ANOVA
Secondary
Fasting Glucose
Fasting glucose from a fingerstick sample
Time frame: baseline and 12-months
Population: Compares the GLB/GLB intervention sequence to GLB+/GLB+ intervention sequence (the primary comparison of interest at 12-months)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group Lifestyle Balance (GLB) | Fasting Glucose | -4.30 mg/dL | Standard Error 1.57 |
| Group Lifestyle Balance Plus (GLB+) | Fasting Glucose | -4.04 mg/dL | Standard Error 1.7 |
Comparison: Comparison of GLB/GLB intervention sequence to GLB+/GLB+ intervention sequence (the primary comparison of interest).p-value: 0.9085ANOVA
Secondary
Fasting Glucose
Fasting glucose from a fingerstick sample
Time frame: 12-months and 18-months
Population: Compares the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest at 18-months)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Group Lifestyle Balance (GLB) | Fasting Glucose | -1.21 mg/dL | Standard Error 2.28 |
| Group Lifestyle Balance Plus (GLB+) | Fasting Glucose | 2.71 mg/dL | Standard Error 2.08 |
Comparison: Comparison between the GLB/GLB intervention sequence and the GLB+/GLB+ intervention sequence (the primary comparison of interest)p-value: 0.2063ANOVA