Clinical trial NCT02589873: Getting in Balance: A Workplace Diabetes Prevention Intervention Trial
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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Overweight
Obesity
Keywords: Lifestyle Intervention
Workplace
Diabetes Prevention
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Body weight lost
timeFrame: 12 months
Secondary outcomes:
measure: Change in minutes of physical activity
timeFrame: 12 months
measure: Change in dietary fat intake
timeFrame: 12 months
measure: Participant engagement
timeFrame: 12 months
measure: Stress and well-being
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: City and County of San Francisco
state: California
Study officials:
affiliation: Kaiser Permanente
name: Assiamira Ferrara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: