Clinical trial NCT04433806: Primary Care Referrals to Community-based Lifestyle Programs for Management of Obesity
Official title: The Feasibility of Primary Care Referrals to Community-based Lifestyle Programs for Management of Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lifestyle, Healthy
Community Based Programs
Primary Care Referrals
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Participants recruited
timeFrame: Through study completion, approximately 28 weeks
measure: Participants enrolled
timeFrame: Through study completion, approximately 28 weeks
measure: Participants accrued
timeFrame: Through study completion, approximately 28 weeks
measure: Participants to withdrawn or terminate study participation
timeFrame: Through study completion, approximately 28 weeks
Secondary outcomes:
measure: Participant satisfaction
timeFrame: At study completion, approximately 28 weeks
measure: Staff satisfaction
timeFrame: At study completion, approximately 28 weeks
measure: Change in weight
timeFrame: Baseline, week 16, week 28
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, week 16, week 28
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Tamim Rajjo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: