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

Primary Purpose

Diabetes Mellitus, Type 2, Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In-Person Diabetes Prevention Program
Online Diabetes Prevention Program
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Lifestyle Intervention, Workplace, Diabetes Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • City and County of San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

In-Person Diabetes Prevention Program

Online Diabetes Prevention Program

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Body weight lost
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.

Secondary Outcome Measures

Change in minutes of physical activity
Change in physical activity duration per week - measured using the International Physical Activity Questionnaire (IPAQ);
Change in dietary fat intake
Change in daily dietary fat intake - measured using the Block Fat Screener
Participant engagement
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.
Stress and well-being
Change in well-being - measured using SF-8 Health Survey

Full Information

First Posted
October 26, 2015
Last Updated
October 9, 2018
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT02589873
Brief Title
Getting in Balance: A Workplace Diabetes Prevention Intervention Trial
Acronym
GIBW
Official Title
A Workplace Intervention Trial Comparing Two Diabetes Prevention Programs - In-person and Online - Delivered in a Large Urban Workplace Environment.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 15, 2017 (Actual)
Study Completion Date
August 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Overweight, Obesity
Keywords
Lifestyle Intervention, Workplace, Diabetes Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-Person Diabetes Prevention Program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Online Diabetes Prevention Program
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
In-Person Diabetes Prevention Program
Other Intervention Name(s)
YMCA DPP
Intervention Description
Lifestyle intervention program involving group-based educational sessions, diet and physical activity tracking, and weekly weigh ins. Participants complete the intervention over 12 months.
Intervention Type
Behavioral
Intervention Name(s)
Online Diabetes Prevention Program
Other Intervention Name(s)
Virtual Lifestyle Management
Intervention Description
Lifestyle intervention program involving web-based educational videos, diet and physical activity tracking, and recording weight. Participants complete the intervention over 12 months.
Primary Outcome Measure Information:
Title
Body weight lost
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in minutes of physical activity
Description
Change in physical activity duration per week - measured using the International Physical Activity Questionnaire (IPAQ);
Time Frame
12 months
Title
Change in dietary fat intake
Description
Change in daily dietary fat intake - measured using the Block Fat Screener
Time Frame
12 months
Title
Participant engagement
Description
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.
Time Frame
12 months
Title
Stress and well-being
Description
Change in well-being - measured using SF-8 Health Survey
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assiamira Ferrara, MD, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
City and County of San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94103
Country
United States

12. IPD Sharing Statement

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Getting in Balance: A Workplace Diabetes Prevention Intervention Trial

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