PreDiabetesNCT03382873

Augmented Care at Worksite for Diabetes Prevention

A study testing Group Lifestyle Balance (GLB) and Group Lifestyle Balance Plus (GLB+) in people with PreDiabetes, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: PreDiabetes
What is being tested?: Group Lifestyle Balance (GLB) and Group Lifestyle Balance Plus (GLB+)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 208 participants
Where: 1 siteUnited States
Study dates: 8 Feb 2018to 15 Apr 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Benefits-eligible Ohio State University (OSU) employee
Intend to be employed by OSU through the length of the follow-up phase
Body mass index: >24 kg/m^2 non-Asians; >22 kg/m^2 Asians
Fasting blood glucose of 100-125 mg/dL or an A1c of 5.7-6.4%
Blood glucose of 110-199 (if non-fasting in previous 2 hours)

Who cannot join

Blood glucose level of ≥ 200 mg/dL
Conditions that would limit adoption of light/moderate physical activity (i.e., cardiac event, severe chronic obstructive pulmonary disease, advanced arthritis, poorly controlled hypertension)
Chronic use of medications that affect blood glucose levels (i.e., corticosteroids)
Concurrent participation in a structured weight loss program or counseling for bariatric surgery
Pregnant or breastfeeding
Score of ≥ 10 on the Patient Health Questionnaire-8 indicating moderate to severe depressive symptoms

Show all 9Show fewer

Score of ≥ 27 on the Binge Eating Scale indicating the potential for binge eating
Unwilling to accept randomization
Planning to move from the area or changing employment.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University
Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Impact of Augmented Care at the Worksite for Diabetes Prevention

Read the 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.

Conditions: PreDiabetes
Being tested: Group Lifestyle Balance (GLB), Group Lifestyle Balance Plus (GLB+)
Keywords: Hyperglycemia, Obese, Overweight
Medical subject headings: Prediabetic State, Hyperglycemia, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group Lifestyle Balance (GLB)Behavioural
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.
Group Lifestyle Balance Plus (GLB+)Behavioural
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.

Study groups in NCT03382873
Study group	Role	What they receive
Group Lifestyle Balance (GLB)	Active comparator	Standard lifestyle intervention to promote weight loss Receives: Behavioral: Group Lifestyle Balance (GLB)
Group Lifestyle Balance Plus (GLB+)	Experimental	Augmented lifestyle intervention for early slow responders Receives: Behavioral: Group Lifestyle Balance Plus (GLB+)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Weight Change
Change in weight as measured in light clothing and shoes removed
Measured: baseline and 4-months
Percent Weight Change
Change in weight as measured in light clothing and shoes removed
Measured: baseline and 12-months
Percent Weight Change
Change in weight as measured in light clothing and shoes removed
Measured: 12-months and 18-months

Secondary outcomes (3)

Fasting Glucose
Fasting glucose from a fingerstick sample
Measured: baseline and 4-months
Fasting Glucose
Fasting glucose from a fingerstick sample
Measured: baseline and 12-months
Fasting Glucose
Fasting glucose from a fingerstick sample
Measured: 12-months and 18-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 201815 Apr 2022

First posted26 Dec 2017
Study start8 Feb 2018
Primary completion15 Apr 2022
Study completion15 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for PreDiabetesStudies of the same condition, open and under way.
More trials run by Ohio State UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 208 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03382873
Sponsor's protocol ID: R01DK112930-01A1
Status last verified: Mar 2024
First submitted: 19 Dec 2017
Last updated: 11 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Publications

Miller CK, Nagaraja HN, Cheavens JS, Fujita K, Lazarus SA, Brunette DS. Sex Differences in Early Weight Loss Success During a Diabetes Prevention Intervention. Am J Health Behav. 2023 Apr 30;47(2):337-348. doi: 10.5993/AJHB.47.2.13.
PubMed 37226352
Miller CK, King D, Nagaraja HN, Fujita K, Cheavens J, Focht BC. Impact of an augmented intervention on self-regulatory, dietary and physical activity outcomes in a diabetes prevention trial among adults with prediabetes. J Behav Med. 2023 Oct;46(5):770-780. doi: 10.1007/s10865-023-00406-w. Epub 2023 Mar 18.
PubMed 36933057
Miller CK, Nagaraja HN, Cheavens J, Fujita K, Lazarus S. Impact of a Novel Diabetes Prevention Intervention for Early Slow Weight Loss Responders Among Adults With Prediabetes: An Adaptive Trial. Diabetes Care. 2022 Oct 1;45(10):2452-2455. doi: 10.2337/dc22-0824.
PubMed 36041053

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Augmented Care at the Worksite for Diabetes Prevention
ClinicalTrials.gov ID: NCT03382873
Acronym / sponsor ID: R01DK112930-01A1
Conditions: PreDiabetes
Keywords: Hyperglycemia, Obese, Overweight
Study type: Interventional
Recruitment status: Completed
Enrolment: 208 participants (actual)
Lead sponsor: Ohio State UniversityUniversity, hospital or other
Study start: 8 Feb 2018 (actual)
Primary completion: 15 Apr 2022 (actual)
Study completion: 15 Apr 2022 (actual)
First posted: 26 Dec 2017 (actual)
Results: Posted 11 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Group Lifestyle Balance (GLB)	Active comparator	Behavioral: Group Lifestyle Balance (GLB)Standard lifestyle intervention to promote weight loss
Group Lifestyle Balance Plus (GLB+)	Experimental	Behavioral: Group Lifestyle Balance Plus (GLB+)Augmented lifestyle intervention for early slow responders

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Benefits-eligible Ohio State University (OSU) employee
Intend to be employed by OSU through the length of the follow-up phase
Body mass index: >24 kg/m^2 non-Asians; >22 kg/m^2 Asians
Fasting blood glucose of 100-125 mg/dL or an A1c of 5.7-6.4%
Blood glucose of 110-199 (if non-fasting in previous 2 hours)

Key exclusion criteria (9 listed)

Blood glucose level of ≥ 200 mg/dL
Conditions that would limit adoption of light/moderate physical activity (i.e., cardiac event, severe chronic obstructive pulmonary disease, advanced arthritis, poorly controlled hypertension)
Chronic use of medications that affect blood glucose levels (i.e., corticosteroids)
Concurrent participation in a structured weight loss program or counseling for bariatric surgery
Pregnant or breastfeeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Group 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.	Behavioural	Group Lifestyle Balance (GLB)
Group 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.	Behavioural	Group Lifestyle Balance Plus (GLB+)

Primary outcome

Percent Weight Change
Time frame: baseline and 4-months
Change in weight as measured in light clothing and shoes removed
Percent Weight Change
Time frame: baseline and 12-months
Change in weight as measured in light clothing and shoes removed
Percent Weight Change
Time frame: 12-months and 18-months
Change in weight as measured in light clothing and shoes removed

3 secondary outcomes

Fasting Glucose
Time frame: baseline and 4-months
Fasting Glucose
Time frame: baseline and 12-months
Fasting Glucose
Time frame: 12-months and 18-months

Results and safety

Results posted to the registry on 11 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group Lifestyle Balance (GLB)	86	55
Group Lifestyle Balance Plus (GLB+)	122	60

Primary outcome: Percent Weight Change

Time frame: baseline and 4-months. Least squares mean (Standard Error). Unit: percent change

Measure	Group Lifestyle Balance (GLB) n = 80	Group Lifestyle Balance Plus (GLB+) n = 111
Value	-8.13 (0.48)	-3.46 (0.31)

Group Lifestyle Balance (GLB) vs Group Lifestyle Balance Plus (GLB+): p <0.0001, ANOVA

Primary outcome: Percent Weight Change

Time frame: baseline and 12-months. Least squares mean (Standard Error). Unit: percent change

Measure	Group Lifestyle Balance (GLB) n = 47	Group Lifestyle Balance Plus (GLB+) n = 59
Value	-9.55 (0.96)	-4.00 (1.05)

Group Lifestyle Balance (GLB) vs Group Lifestyle Balance Plus (GLB+): p = 0.0001, ANOVA

Population analysed: Compares the change for the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest at 12-months)

Primary outcome: Percent Weight Change

Time frame: 12-months and 18-months. Least squares mean (Standard Error). Unit: percent change

Measure	Group Lifestyle Balance (GLB) n = 27	Group Lifestyle Balance Plus (GLB+) n = 42
Value	2.22 (0.59)	2.28 (0.56)

Group Lifestyle Balance (GLB) vs Group Lifestyle Balance Plus (GLB+): p = 0.9476, ANOVA

Population analysed: Compares the GLB/GLB intervention sequence to the GLB+/GLB+ intervention sequence (the primary comparison of interest at 18-months for weight loss maintenance)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group Lifestyle Balance (GLB)	2 of 86 (2.3%)	4 of 86 (4.7%)	0 of 86
Group Lifestyle Balance Plus (GLB+)	3 of 122 (2.5%)	13 of 122 (10.7%)	1 of 122

Limitations and caveats (from the sponsor): Four participant cohorts did not complete the 18-month visit due to pandemic-related restrictions during the SARS-CoV-2 pandemic. Thus, the 18-month outcomes include a smaller sample and should be interpreted with caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37226352Miller CK, Nagaraja HN, Cheavens JS, Fujita K, Lazarus SA, Brunette DS. Sex Differences in Early Weight Loss Success During a Diabetes Prevention Intervention. Am J Health Behav. 2023 Apr 30;47(2):337-348. doi: 10.5993/AJHB.47.2.13.
Derived from this study: PubMed 36933057Miller CK, King D, Nagaraja HN, Fujita K, Cheavens J, Focht BC. Impact of an augmented intervention on self-regulatory, dietary and physical activity outcomes in a diabetes prevention trial among adults with prediabetes. J Behav Med. 2023 Oct;46(5):770-780. doi: 10.1007/s10865-023-00406-w. Epub 2023 Mar 18.
Derived from this study: PubMed 36041053Miller CK, Nagaraja HN, Cheavens J, Fujita K, Lazarus S. Impact of a Novel Diabetes Prevention Intervention for Early Slow Weight Loss Responders Among Adults With Prediabetes: An Adaptive Trial. Diabetes Care. 2022 Oct 1;45(10):2452-2455. doi: 10.2337/dc22-0824.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carla Miller, Ph.D. principal investigator

The Ohio State University (during study implementation)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Group Lifestyle Balance (GLB) and Group Lifestyle Balance Plus (GLB+) in people with PreDiabetes, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Weight Change (time frame: baseline and 4-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03382873, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.