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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Lifestyle, Healthy; Community Based Programs; Primary Care Referrals
• Intervention / Treatment: Behavioral: Referral to weight loss program

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Tamim Rajjo, MD, MPH, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 19-010206

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No