Obesity Clinical Trial
Official title:
The Feasibility of Primary Care Referrals to Community-based Lifestyle Programs for Management of Obesity
Verified date | September 2022 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purposes of this study is to evaluate the feasibility of providing a community based referral to Mayo Clinic Employee and Community Health patients for weight loss.
Status | Completed |
Enrollment | 23 |
Est. completion date | May 1, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patients who are between 18-65 years of age - Patients who have a BMI between 25-39.9 kg/m2 - Ability to provide informed consent - Ability to complete the Diabetes Prevention Program including dietary and physical activity recommendations - Motivated to lose weight (assessed to be in the preparation or action stage) Exclusion Criteria: - Have used weight loss medications or participated in a weight loss program within the past 30 days. - Are currently enrolled in DPP or other ExercisAbilities weight loss programs - Are currently taking supplements known to affect weight. - Have had weight fluctuations of 20 pounds or more in the past 6 months (EMR check and self-report) - Have an active untreated clinically significant psychiatric condition (psychosis, bipolar disorder, or depression) - Are currently pregnant or breastfeeding, or are of child-bearing potential and are likely to become pregnant during the study (within the next 4 months following enrollment) - Have a history in the past 4 months of any major cardiovascular events including heart valve disease, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease - Have current uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 95 mm Hg) documented on 2 separate occasions - Have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease (such as diabetes) or active cancer or are within 1 year of cancer remission - Have a known history of any condition or factor judged by the investigator/study team to preclude participation in the study or which might hinder adherence - Have any co-morbidity that is deemed exclusionary at the discretion of the provider. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participants recruited | Total number of participants recruited | Through study completion, approximately 28 weeks | |
Primary | Participants enrolled | Total number of participants enrolled | Through study completion, approximately 28 weeks | |
Primary | Participants accrued | Total number of participants accrued | Through study completion, approximately 28 weeks | |
Primary | Participants to withdrawn or terminate study participation | Total number of participants to withdrawn or terminate study participation | Through study completion, approximately 28 weeks | |
Secondary | Participant satisfaction | Measured using the self-reported Was It Worth It (WIWI) Questionnaire that uses a total of 13 questions that asks feedback on participants experience and satisfaction with the Mayo Clinic/ExercisAbilities weight loss program. | At study completion, approximately 28 weeks | |
Secondary | Staff satisfaction | Measured using the self-reported ExercisAbilities Staff Survey (Post-Intervention) that uses a total of 3 questions to rate experience on a scale of very satisfied to extremely not satisfied. | At study completion, approximately 28 weeks | |
Secondary | Change in weight | Change in participant's weight measure in kilograms (kg) | Baseline, week 16, week 28 | |
Secondary | Change in Body Mass Index (BMI) | Change in participant's BMI calculated by weight in kilograms divided by the square of height in meters (kg/m2) | Baseline, week 16, week 28 |
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