Community Based Programs, Lifestyle, Healthy, Obesity, Primary Care Referrals
Conditions
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.
Interventions
BEHAVIORALReferral to weight loss program
16 weeks Diabetes Prevention Program based weight loss program at a local community partner
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants to withdrawn or terminate study participation | Through study completion, approximately 28 weeks | Total number of participants to withdrawn or terminate study participation |
| Participants recruited | Through study completion, approximately 28 weeks | Total number of participants recruited |
| Participants enrolled | Through study completion, approximately 28 weeks | Total number of participants enrolled |
| Participants accrued | Through study completion, approximately 28 weeks | Total number of participants accrued |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Change in weight | Baseline, week 16, week 28 | Change in participant's weight measure in kilograms (kg) |
| 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) |
Countries
United States
Outcome results
None listed