Getting in Balance: A Workplace Diabetes Prevention Intervention Trial
NCT ID: NCT02589873
Last Updated: 2018-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
157 participants
INTERVENTIONAL
2015-09-30
2017-08-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Assiamira Ferrara, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Locations
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City and County of San Francisco
San Francisco, California, United States
Countries
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Other Identifiers
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CN-15-2318-H
Identifier Type: -
Identifier Source: org_study_id
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