Primary Care Referrals to Community-based Lifestyle Programs for Management of Obesity
- Conditions
- Lifestyle, HealthyObesityPrimary Care ReferralsCommunity Based Programs
- Registration Number
- NCT04433806
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Participants enrolled Through study completion, approximately 28 weeks Total number of participants enrolled
Participants recruited Through study completion, approximately 28 weeks Total number of participants recruited
Participants accrued Through study completion, approximately 28 weeks Total number of participants accrued
Participants to withdrawn or terminate study participation Through study completion, approximately 28 weeks Total number of participants to withdrawn or terminate study participation
- Secondary Outcome Measures
Name Time Method Change in Body Mass Index (BMI) Baseline, week 16, week 28 Change in participant's BMI calculated by weight in kilograms divided by the square of height in meters (kg/m2)
Participant satisfaction At study completion, approximately 28 weeks 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.
Change in weight Baseline, week 16, week 28 Change in participant's weight measure in kilograms (kg)
Staff satisfaction At study completion, approximately 28 weeks 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.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Mayo Clinic in Rochester🇺🇸Rochester, Minnesota, United States