Getting in Balance: A Workplace Diabetes Prevention Intervention Trial (GIBW)

October 9, 2018 updated by: Kaiser Permanente

A Workplace Intervention Trial Comparing Two Diabetes Prevention Programs - In-person and Online - Delivered in a Large Urban Workplace Environment.

This study evaluates two group-based Diabetes Prevention Program (DPP) lifestyle interventions delivered in the workplace to individuals at risk for pre-diabetes: 1) an in-person group-based lifestyle intervention; and 2) an internet-based intervention delivered using an online platform with lifestyle coaching support. Eligible participants will be randomized equally to each intervention program (120 participants in each).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study seeks to compare weight loss, changes in physical activity and dietary fat intake, and participant engagement in two Diabetes Prevention Program (DPP) interventions derived from the Centers for Disease Control and Prevention (CDC) curriculum: an in-person and an internet-based intervention program.

We hypothesize that the internet-based intervention will be more effective in achieving weight loss than the in-person intervention, given its convenience for participants to complete sessions and therefore greater potential engagement in the program.

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94103
        • City and County of San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ethnicity: All ethnic groups;
  • Sex: all genders;
  • Age (as of date of enrollment): Lower age limit: 18 years; Upper age limit: NONE;
  • Body mass index ≥ 25.0 kg/m2; ≥23 kg/m2 if Asian
  • Having pre-diabetes based on a score of 9+ on the CDC pre-diabetes screener
  • Able and willing to enroll and provide written, informed consent, i.e., to:
  • meet the time and data collection requirements of the study;
  • be randomized to one of the two intervention programs;
  • adhere to the recommendations of the study intervention as assigned; and
  • participate in follow-up for 12 months.

Exclusion Criteria:

  • Does not work at one of the participating employer work locations/departments;
  • Inability to speak, read, or understand English;
  • No regular access to a computer with internet capabilities;
  • Diagnosis of Type 1 or Type 2 diabetes mellitus;
  • Systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 100 mm Hg on more than one occasion during the last year;
  • Having a medical or physical condition that make moderate intensity physical activity (like a brisk walk) difficult or unsafe, such as exercise induced asthma or chronic obstructive pulmonary disease (COPD);
  • Use of weight-loss medications in the past 3 months;
  • Regular use (> 5 days/month) of medications that affect appetite or weight (e.g., oral corticosteroids, insulin, oral hypoglycemics etc.);
  • Currently enrolled in a weight loss program;
  • Planning to undergo bariatric surgery during the study period;
  • Heart disease (angina, heart attack (myocardial infarction), congestive heart failure (CHF)), stroke;
  • Renal insufficiency;
  • Diagnosis of cancer (other than non-melanoma skin cancer) that was active or treated with radiation or chemotherapy within the past 2 years;
  • Pregnant, lactating or planning to become pregnant during the study period;
  • Already enrolled or planning to enroll in a research study that would limit full participation in this study or confound the observation and interpretation of the study's findings;
  • Planning to transfer to another department location during the study period;
  • Planning to move out of the area during the study period;
  • Investigator discretion for clinical safety or protocol adherence reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: In-Person Diabetes Prevention Program
An in-person group delivery modality of a CDC recognized Diabetes Prevention Program (DPP), delivered by the Young Men's Christian Association (YMCA). This group receives lifestyle coaching in a group setting, meeting weekly for 16 weeks followed by 3 biweekly sessions, and 5 monthly maintenance sessions.
Behavioral: In-Person Diabetes Prevention Program
Lifestyle intervention program involving group-based educational sessions, diet and physical activity tracking, and weekly weigh ins. Participants complete the intervention over 12 months.
Other Names:
  • YMCA DPP
Active Comparator: Online Diabetes Prevention Program
An online delivery modality of a CDC recognized Diabetes Prevention Program (DPP), delivered by Canary Health's Virtual Lifestyle Management program. This group completes online learning sessions weekly for 16 weeks followed by 8 monthly maintenance sessions.
Behavioral: Online Diabetes Prevention Program
Lifestyle intervention program involving web-based educational videos, diet and physical activity tracking, and recording weight. Participants complete the intervention over 12 months.
Other Names:
  • Virtual Lifestyle Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight lost
Time Frame: 12 months
Percentage of body weight lost and the amount of weight lost (in pounds) on average over the 12 month follow-up, and at 6 and 12 months compared to baseline, by intervention arm. Body weight will be collected at baseline, 6 months, and 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in minutes of physical activity
Time Frame: 12 months
Change in physical activity duration per week - measured using the International Physical Activity Questionnaire (IPAQ);
12 months
Change in dietary fat intake
Time Frame: 12 months
Change in daily dietary fat intake - measured using the Block Fat Screener
12 months
Participant engagement
Time Frame: 12 months
Participant engagement - measured by the number of intervention sessions completed by 6 months, as well as the number of maintenance sessions completed between 6 and 12 months.
12 months
Stress and well-being
Time Frame: 12 months
Change in well-being - measured using SF-8 Health Survey
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Investigators

  • Principal Investigator: Assiamira Ferrara, MD, PhD, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

August 15, 2017

Study Completion (Actual)

August 15, 2017

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN-15-2318-H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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