An interventional study of Group Lifestyle Balance (GLB) and Group Lifestyle Balance Plus (GLB+) in PreDiabetes, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.
Sponsored by Ohio State University · Not applicable, Interventional, and Prevention
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Among 10 studies in Prediabetic State by Ohio State University — 1 open to participants now, 3 under way, none of them phase 3. Prediabetic State · Ohio State University.
Among the 10 studies in Prediabetic State by Ohio State University, this one is the 2nd largest by enrollment, is the only one that started in 2018, is one of 9 with no phase, and was the 6th registered.
918 studies on the registry are indexed under Prediabetic State; 231 are open to participants now.
Browse Prediabetic State studies →1 of the 10 studies in Prediabetic State by Ohio State University is open now, in 1 country. Recruiting first, the newest first:
Ohio State University · Sites in United States
Ages 18+ · Women only
By country, each count listing its studies:
Of the 144 Prediabetic State studies recruiting now, 51 (35%) set no upper age limit and 83 (58%) stop at 75 or younger; 12 take children under 18; 54 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 208 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Median enrollment 72 across the 10 interventional studies. Of the 7 that completed or were terminated, 5 (71%) have results posted.
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Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
1 of the studies in Prediabetic State by Ohio State University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05909046Ohio State UniversityA Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE | 2026-12 |
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Among the 10 studies in Prediabetic State by Ohio State University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard lifestyle intervention to promote weight loss
Behavioral: Group Lifestyle Balance (GLB)
Augmented lifestyle intervention for early slow responders
Behavioral: Group Lifestyle Balance Plus (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.
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.
Percent Weight Change
Change in weight as measured in light clothing and shoes removed
Time frame: baseline and 4-months
Percent Weight Change
Change in weight as measured in light clothing and shoes removed
Time frame: baseline and 12-months
Percent Weight Change
Change in weight as measured in light clothing and shoes removed
Time frame: 12-months and 18-months
Fasting Glucose
Fasting glucose from a fingerstick sample
Time frame: baseline and 4-months
Fasting Glucose
Fasting glucose from a fingerstick sample
Time frame: baseline and 12-months
Fasting Glucose
Fasting glucose from a fingerstick sample
Time frame: 12-months and 18-months
Employees from a Midwestern university with overweight or obesity and prediabetes were recruited from 2018-2021.
| Milestone | Group Lifestyle Balance (GLB) | Group Lifestyle Balance Plus (GLB+) |
|---|---|---|
| Started | 86 | 122 |
| Completed 4-months | 80 | 111 |
| Randomized at 5-months | 94 | 96 |
| Completed 12-months | 87 | 88 |
| Completed 18-months | 55 | 60 |
| Completed | 55 | 60 |
| Not completed | 31 | 62 |
| Withdrew: Lost to follow-up | 9 | 10 |
| Withdrew: Withdrawal by subject | 6 | 11 |
| Withdrew: Visit not completed due to pandemic | 16 | 41 |
Change in weight as measured in light clothing and shoes removed
| percent change | Group Lifestyle Balance (GLB) | Group Lifestyle Balance Plus (GLB+) |
|---|---|---|
| Percent Weight Change | -8.13 ± 0.48 | -3.46 ± 0.31 |
Change in weight as measured in light clothing and shoes removed
| percent change | Group Lifestyle Balance (GLB) | Group Lifestyle Balance Plus (GLB+) |
|---|---|---|
| Percent Weight Change | -9.55 ± 0.96 | -4.00 ± 1.05 |
Change in weight as measured in light clothing and shoes removed
| percent change | Group Lifestyle Balance (GLB) | Group Lifestyle Balance Plus (GLB+) |
|---|---|---|
| Percent Weight Change | 2.22 ± 0.59 | 2.28 ± 0.56 |
Fasting glucose from a fingerstick sample
| mg/dL | Group Lifestyle Balance (GLB) | Group Lifestyle Balance Plus (GLB+) |
|---|---|---|
| Fasting Glucose | -7.01 ± 1.13 | -3.18 ± 0.98 |
Fasting glucose from a fingerstick sample
| mg/dL | Group Lifestyle Balance (GLB) | Group Lifestyle Balance Plus (GLB+) |
|---|---|---|
| Fasting Glucose | -4.30 ± 1.57 | -4.04 ± 1.70 |
Fasting glucose from a fingerstick sample
| mg/dL | Group Lifestyle Balance (GLB) | Group Lifestyle Balance Plus (GLB+) |
|---|---|---|
| Fasting Glucose | -1.21 ± 2.28 | 2.71 ± 2.08 |
Collected over 18 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group Lifestyle Balance (GLB) | 0/86 (0%) | 2/86 (2.3%) | 4/86 (4.7%) |
| Group Lifestyle Balance Plus (GLB+) | 1/122 (0.8%) | 3/122 (2.5%) | 13/122 (10.7%) |
| Event | Group Lifestyle Balance (GLB) | Group Lifestyle Balance Plus (GLB+) |
|---|---|---|
| Colon abscessGastrointestinal disorders | 1/86 | 0/122 |
| Hand surgerySurgical and medical procedures | 1/86 | 0/122 |
| Hamstring tearMusculoskeletal and connective tissue disorders | 0/86 | 1/122 |
| Hip replacementSurgical and medical procedures | 0/86 | 1/122 |
| ArrythmiaCongenital, familial and genetic disorders | 0/86 | 1/122 |
| Event | Group Lifestyle Balance (GLB) | Group Lifestyle Balance Plus (GLB+) |
|---|---|---|
| Muscle sorenessMusculoskeletal and connective tissue disorders | 2/86 | 8/122 |
| Knee or hip painMusculoskeletal and connective tissue disorders | 4/86 | 5/122 |
Excludes people who withdrew from the study following stratification to treatment group
| Age, Continuous(years) | Group Lifestyle Balance (GLB) | Group Lifestyle Balance Plus (GLB+) | Total |
|---|---|---|---|
| Mean | 52.7 ± 10.0 | 51.5 ± 10.2 | 52.1 ± 10.1 |
| Sex: Female, Male(Participants) | Group Lifestyle Balance (GLB) | Group Lifestyle Balance Plus (GLB+) | Total |
|---|---|---|---|
| Female | 50 | 90 | 140 |
| Male | 30 | 21 | 51 |
| Ethnicity (NIH/OMB)(Participants) | Group Lifestyle Balance (GLB) | Group Lifestyle Balance Plus (GLB+) | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 4 | 5 |
| Not Hispanic or Latino | 79 | 105 | 184 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Group Lifestyle Balance (GLB) | Group Lifestyle Balance Plus (GLB+) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 5 | 8 | 13 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 18 | 23 |
| White | 70 | 81 | 151 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Body weight(kg) | Group Lifestyle Balance (GLB) | Group Lifestyle Balance Plus (GLB+) | Total |
|---|---|---|---|
| Least squares mean | 102.6 ± 2.7 | 102.5 ± 2.3 | 102.5 ± 1.8 |
| Fasting glucose(mg/dL) | Group Lifestyle Balance (GLB) | Group Lifestyle Balance Plus (GLB+) | Total |
|---|---|---|---|
| Least squares mean | 109.24 ± 1.14 | 107.58 ± 0.99 | 108.1 ± 0.71 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified data will be released to other researchers using a data-sharing agreement that specifies that the data will be used only for research purposes and only by the specified individuals to whom the data are released. Documentation of Institutional Review Board approval for the proposed use must be provided in advance to the PI. The data must be either destroyed or returned to the PI after all analyses are completed.
Supporting information: Clinical study report
Time frame: The data will be available following all analyses and publication of primary and secondary study results. The data will be available upon request.
Access criteria: To be developed
Ran from Feb 2018 to primary completion in Apr 2022, 50 months.
Results were first posted in Apr 2024, 1 year 11 months after primary completion.
Of 378 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 38. This study's 50 months is above that.
Counting every sponsor, half of 424 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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