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

NCT ID: NCT04433806

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2022-05-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

25 subjects, all referred to community based program for weight loss at ExercisAbilities

Group Type: EXPERIMENTAL

Referral to weight loss program

Intervention Type: BEHAVIORAL

16 weeks Diabetes Prevention Program based weight loss program at a local community partner

Interventions

Referral to weight loss program

16 weeks Diabetes Prevention Program based weight loss program at a local community partner

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Tamim I. Rajjo, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamim Rajjo, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

19-010206

Identifier Type: -

Identifier Source: org_study_id