Diabetes Mellitus, Type 2GIBWNCT02589873

Getting in Balance: A Workplace Diabetes Prevention Intervention Trial

A study testing In-Person Diabetes Prevention Program and Online Diabetes Prevention Program in people with Diabetes Mellitus, Type 2 and Overweight, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2, Overweight, Obesity
What is being tested?: In-Person Diabetes Prevention Program and Online Diabetes Prevention Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 157 participants
Where: 1 siteUnited States
Study dates: Sep 2015to 15 Aug 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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:

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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.

Who cannot join

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);

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

City and County of San Francisco
San Francisco, California, 94103

Other trials in United States

About this study

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

Read the 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.

Conditions: Diabetes Mellitus, Type 2, Overweight, Obesity
Being tested: In-Person Diabetes Prevention Program, Online Diabetes Prevention Program
Keywords: Lifestyle Intervention, Workplace, Diabetes Prevention
Medical subject headings: Diabetes Mellitus, Type 2, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

In-Person Diabetes Prevention ProgramBehavioural
Also called YMCA DPP
Lifestyle intervention program involving group-based educational sessions, diet and physical activity tracking, and weekly weigh ins. Participants complete the intervention over 12 months.
Online Diabetes Prevention ProgramBehavioural
Also called Virtual Lifestyle Management
Lifestyle intervention program involving web-based educational videos, diet and physical activity tracking, and recording weight. Participants complete the intervention over 12 months.

Study groups in NCT02589873
Study group	Role	What they receive
In-Person Diabetes Prevention Program	Active comparator	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. Receives: Behavioral: In-Person Diabetes Prevention Program
Online Diabetes Prevention Program	Active comparator	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. Receives: Behavioral: Online Diabetes Prevention Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (4)

Change in minutes of physical activity
Change in physical activity duration per week - measured using the International Physical Activity Questionnaire (IPAQ);
Measured: 12 months
Change in dietary fat intake
Change in daily dietary fat intake - measured using the Block Fat Screener
Measured: 12 months
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.
Measured: 12 months
Stress and well-being
Change in well-being - measured using SF-8 Health Survey
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201515 Aug 2017

First posted28 Oct 2015 (estimated)
Study startSep 2015
Primary completion15 Aug 2017
Study completion15 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Kaiser PermanenteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 157 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02589873
Sponsor's protocol ID: CN-15-2318-H
Acronym: GIBW
Status last verified: Oct 2018
First submitted: 26 Oct 2015
Last updated: 10 Oct 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Workplace Intervention Trial Comparing Two Diabetes Prevention Programs - In-person and Online - Delivered in a Large Urban Workplace Environment.
ClinicalTrials.gov ID: NCT02589873
Acronym / sponsor ID: GIBW / CN-15-2318-H
Conditions: Diabetes Mellitus, Type 2, Overweight, Obesity
Keywords: Lifestyle Intervention, Workplace, Diabetes Prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 157 participants (actual)
Lead sponsor: Kaiser PermanenteUniversity, hospital or other
Study start: Sep 2015
Primary completion: 15 Aug 2017 (actual)
Study completion: 15 Aug 2017 (actual)
First posted: 28 Oct 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
In-Person Diabetes Prevention Program	Active comparator	Behavioral: In-Person Diabetes Prevention ProgramAn 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.
Online Diabetes Prevention Program	Active comparator	Behavioral: Online Diabetes Prevention ProgramAn 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (18 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
In-Person Diabetes Prevention ProgramAlso: YMCA DPPLifestyle intervention program involving group-based educational sessions, diet and physical activity tracking, and weekly weigh ins. Participants complete the intervention over 12 months.	Behavioural	In-Person Diabetes Prevention Program
Online Diabetes Prevention ProgramAlso: Virtual Lifestyle ManagementLifestyle intervention program involving web-based educational videos, diet and physical activity tracking, and recording weight. Participants complete the intervention over 12 months.	Behavioural	Online Diabetes Prevention Program

Primary outcome

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.

4 secondary outcomes

Change in minutes of physical activity
Time frame: 12 months
Change in dietary fat intake
Time frame: 12 months
Participant engagement
Time frame: 12 months
Stress and well-being
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Assiamira Ferrara, MD, PhD principal investigator

Kaiser Permanente

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body weight lost (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02589873.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.