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Completed

NCT Number: NCT03382873

Augmented Care at Worksite for Diabetes Prevention

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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 indicating the potential for binge eating
  • Unwilling to accept randomization
  • Planning to move from the area or changing employment.

Treatment and study plan

Group Lifestyle Balance (GLB)

Behavioral

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+)

Behavioral

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.

Primary outcomes

  1. Percent Weight Change

    Time frame: baseline and 4-months

    Change in weight as measured in light clothing and shoes removed

  2. Percent Weight Change

    Time frame: baseline and 12-months

    Change in weight as measured in light clothing and shoes removed

  3. Percent Weight Change

    Time frame: 12-months and 18-months

    Change in weight as measured in light clothing and shoes removed

Secondary outcomes

  1. Fasting Glucose

    Time frame: baseline and 4-months

    Fasting glucose from a fingerstick sample

  2. Fasting Glucose

    Time frame: baseline and 12-months

    Fasting glucose from a fingerstick sample

  3. Fasting Glucose

    Time frame: 12-months and 18-months

    Fasting glucose from a fingerstick sample

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Impact of Augmented Care at the Worksite for Diabetes Prevention

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 26, 2017
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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