Primary Care Referrals to Community-based Lifestyle Programs for Management of Obesity

Study Overview
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Brief Summary
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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.

Official Title
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The Feasibility of Primary Care Referrals to Community-based Lifestyle Programs for Management of Obesity

Conditions
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Obesity, Lifestyle, Healthy, Community Based Programs, Primary Care Referrals

Intervention / Treatment
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* Behavioral: Referral to weight loss program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>25 subjects, all referred to community based program for weight loss at ExercisAbilities | Behavioral: Referral to weight loss program<br>* 16 weeks Diabetes Prevention Program based weight loss program at a local community partner<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants recruited | Total number of participants recruited | Through study completion, approximately 28 weeks | 
| Participants enrolled | Total number of participants enrolled | Through study completion, approximately 28 weeks | 
| Participants accrued | Total number of participants accrued | Through study completion, approximately 28 weeks | 
| Participants to withdrawn or terminate study participation | Total number of participants to withdrawn or terminate study participation | Through study completion, approximately 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Change in weight | Change in participant's weight measure in kilograms (kg) | Baseline, week 16, week 28 | 
| 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 |