Obesity Clinical Trial
— GIBWOfficial title:
A Workplace Intervention Trial Comparing Two Diabetes Prevention Programs - In-person and Online - Delivered in a Large Urban Workplace Environment.
Verified date | October 2018 |
Source | Kaiser Permanente |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 157 |
Est. completion date | August 15, 2017 |
Est. primary completion date | August 15, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | City and County of San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Kaiser Permanente |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 months | |
Secondary | Change in minutes of physical activity | Change in physical activity duration per week - measured using the International Physical Activity Questionnaire (IPAQ); | 12 months | |
Secondary | Change in dietary fat intake | Change in daily dietary fat intake - measured using the Block Fat Screener | 12 months | |
Secondary | 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. | 12 months | |
Secondary | Stress and well-being | Change in well-being - measured using SF-8 Health Survey | 12 months |
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