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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04433806
• Other study ID #: 19-010206
• Status: Completed
• Phase: N/A
• Start date: September 21, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: September 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Referral to weight loss program
16 weeks Diabetes Prevention Program based weight loss program at a local community partner

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants recruited	Total number of participants recruited	Through study completion, approximately 28 weeks
Primary	Participants enrolled	Total number of participants enrolled	Through study completion, approximately 28 weeks
Primary	Participants accrued	Total number of participants accrued	Through study completion, approximately 28 weeks
Primary	Participants to withdrawn or terminate study participation	Total number of participants to withdrawn or terminate study participation	Through study completion, approximately 28 weeks
Secondary	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
Secondary	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
Secondary	Change in weight	Change in participant's weight measure in kilograms (kg)	Baseline, week 16, week 28
Secondary	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

External Links

•   Mayo Clinic Clinical Trials