Augmented Care at Worksite for Diabetes Prevention

NCT03382873 | Completed Results DMC

• 1 other identifier: R01DK112930-01A1
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

PreDiabetes

Keywords

Hyperglycemia; Obese; Overweight

Outcome Measures

Primary Outcomes (3)

• Percent Weight Change

  Change in weight as measured in light clothing and shoes removed

  baseline and 4-months

• Percent Weight Change

  Change in weight as measured in light clothing and shoes removed

  baseline and 12-months

• Percent Weight Change

  Change in weight as measured in light clothing and shoes removed

  12-months and 18-months

Secondary Outcomes (3)

• Fasting Glucose

  baseline and 4-months

• Fasting Glucose

  baseline and 12-months

• Fasting Glucose

  12-months and 18-months

Study Arms (2)

Group Lifestyle Balance (GLB)

ACTIVE COMPARATOR

Standard lifestyle intervention to promote weight loss

Behavioral: Group Lifestyle Balance (GLB)

Group Lifestyle Balance Plus (GLB+)

EXPERIMENTAL

Augmented lifestyle intervention for early slow responders

Behavioral: Group Lifestyle Balance Plus (GLB+)

Interventions

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 (GLB)

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.

Group Lifestyle Balance Plus (GLB+)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (3)

• 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.

  PMID: 37226352 DERIVED

• 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.

  PMID: 36933057 DERIVED

• 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.

  PMID: 36041053 DERIVED

MeSH Terms

Conditions

Prediabetic State; Hyperglycemia; Obesity; Overweight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Carla Miller (current affiliation)
• Organization: Indiana University

ckm1@iu.edu

812-855-1608

Study Officials

• Carla Miller, Ph.D.

  The Ohio State University (during study implementation)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (current affiliation at Indiana University)

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 26, 2017
• Study Start: February 8, 2018
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: April 11, 2024
• Results First Posted: April 11, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• 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

Locations

US (1)