Getting in Balance: A Workplace Diabetes Prevention Intervention Trial



Status:Completed
Conditions:Obesity Weight Loss, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:10/12/2018
Start Date:September 2015
End Date:August 15, 2017

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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).

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.

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.
We found this trial at
1
site
San Francisco, California 94103
Phone: 510-891-3505
?
mi
from
San Francisco, CA
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