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Augmented Care at Worksite for Diabetes Prevention

Primary Purpose

PreDiabetes

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Group Lifestyle Balance (GLB)

Group Lifestyle Balance Plus (GLB+)

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring Hyperglycemia, Obese, Overweight

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Benefits-eligible Ohio State University employee
Intend to be employed by OSU through the length of the follow-up phase
Body mass index: >24 kg/m2 non-Asians; >22 kg/m2 Asians
American Diabetes Association risk score of ≥ 5
Fasting blood glucose of 100-125 mg/dL
Blood glucose of 110-199 (if non-fasting in previous 2 hours)

Exclusion Criteria:

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

Sites / Locations

The Ohio State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group Lifestyle Balance (GLB)

Group Lifestyle Balance Plus (GLB+)

Arm Description

Implement the first 4-sessions of the core 16-session phase of the GLB intervention for diabetes prevention to all participants. Determine percent weight change at week 5. Those who achieve >2.5% weight loss at week 5 will remain in the GLB arm.

Implement the first 4-sessions of the core 16-session phase of the GLB intervention for diabetes prevention to all participants. Determine percent weight change at week 5. Those who fail to achieve >2.5% weight loss at week 5 will transfer to the GLB+ arm.

Outcomes

Primary Outcome Measures

Weight loss

Weight will be used to calculate percentage change in body weight.

Secondary Outcome Measures

Decreased Glycemia

Glucose level will be assessed from a fingerstick capillary blood sample.

Full Information

NCT ID

NCT03382873

First Posted

December 19, 2017

Last Updated

February 23, 2021

Sponsor

Ohio State University

1. Study Identification

Unique Protocol Identification Number

NCT03382873

Brief Title

Augmented Care at Worksite for Diabetes Prevention

Official Title

Impact of Augmented Care at the Worksite for Diabetes Prevention

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Recruiting

Study Start Date

February 8, 2018 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of the study is to evaluate the impact of augmented care at the worksite through a lifestyle intervention for diabetes prevention among employees with prediabetes who are slower to respond to a standard diabetes prevention intervention.

Detailed Description

Employees at The Ohio State University (OSU) with prediabetes will participate in a standard lifestyle intervention for diabetes prevention. Participants who do not achieve >2.5% weight loss by week 5 of the intervention will transition into augmented care with an enhanced training program that addresses values clarification, decision making, planning, and problem solving. The impact of the enhanced intervention will be evaluated at 4, 12 and 18 months from baseline to determine if implementing early enhanced training helps participants achieve and maintain weight loss similar to those who received the standard intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PreDiabetes

Keywords

Hyperglycemia, Obese, Overweight

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The proposed translational study applies an innovative experimental approach, an adaptive design, to optimize treatment for weight loss and weight loss maintenance in individuals with prediabetes. All participants will begin a standard lifestyle intervention to promote weight loss. Those who do not achieve >2.5% weight loss during the first month of the intervention will transition to augmented care to enhance weight loss during the intensive intervention phase. Following the intensive phase, participants will be 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 will be evaluated.

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group Lifestyle Balance (GLB)

Arm Type

Active Comparator

Arm Description

Arm Title

Group Lifestyle Balance Plus (GLB+)

Arm Type

Experimental

Arm Description

Implement the first 4-sessions of the core 16-session phase of the GLB intervention for diabetes prevention to all participants. Determine percent weight change at week 5. Those who fail to achieve >2.5% weight loss at week 5 will transfer to the GLB+ arm.

Intervention Type

Behavioral

Intervention Name(s)

Group Lifestyle Balance (GLB)

Intervention Description

The intervention includes the following key features: 1) individual case managers or "lifestyle coaches;" 2) frequent contact with participants; 3) a structured, state-of-the-art, 16-session core-curriculum that teaches behavioral self-management strategies for weight loss and physical activity; 4) a more flexible maintenance intervention, combining group and individual approaches and motivational campaigns; 6) individualization through a "toolbox" of adherence strategies; and 7) tailoring of materials and strategies utilizing a network of training, feedback, and support.

Intervention Type

Behavioral

Intervention Name(s)

Group Lifestyle Balance Plus (GLB+)

Intervention Description

The GLB+ intervention arm will include participants who did not achieve the targeted percentage of weight loss by week 5, and will add enhanced training to the program that will focus on values clarification, mindful decision making, planning, and problem solving.

Primary Outcome Measure Information:

Title

Weight loss

Description

Weight will be used to calculate percentage change in body weight.

Time Frame

Weight will be taken at baseline, 4 months (mos), 12 months, and 18 months

Secondary Outcome Measure Information:

Title

Decreased Glycemia

Description

Glucose level will be assessed from a fingerstick capillary blood sample.

Time Frame

Glucose will be taken at baseline, 4 mos, 12 mos, and 18 mos.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Benefits-eligible Ohio State University employee Intend to be employed by OSU through the length of the follow-up phase Body mass index: >24 kg/m2 non-Asians; >22 kg/m2 Asians American Diabetes Association risk score of ≥ 5 Fasting blood glucose of 100-125 mg/dL Blood glucose of 110-199 (if non-fasting in previous 2 hours) Exclusion Criteria: 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 Score of ≥ 27 on the Binge Eating Scale Unwilling to accept randomization Planning to move from the area or changing employment.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carla Miller, Ph.D.

Phone

614-292-1391

miller.4453@osu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carla Miller, Ph.D.

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carla Miller, Ph.D.

Phone

614-292-1391

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

To be developed

Citations:

PubMed Identifier

26605710

Citation

Weinhold KR, Miller CK, Marrero DG, Nagaraja HN, Focht BC, Gascon GM. A Randomized Controlled Trial Translating the Diabetes Prevention Program to a University Worksite, Ohio, 2012-2014. Prev Chronic Dis. 2015 Nov 25;12:E210. doi: 10.5888/pcd12.150301.

Results Reference

result

PubMed Identifier

26095435

Citation

Miller CK, Nagaraja HN, Weinhold KR. Early weight-loss success identifies nonresponders after a lifestyle intervention in a worksite diabetes prevention trial. J Acad Nutr Diet. 2015 Sep;115(9):1464-71. doi: 10.1016/j.jand.2015.04.022. Epub 2015 Jun 19.

Results Reference

result

PubMed Identifier

36041053

Citation

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.

Results Reference

derived

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Augmented Care at Worksite for Diabetes Prevention

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