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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04433806
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 27.3
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Lifestyle, Healthy; Community Based Programs; Primary Care Referrals	Behavioral: Referral to weight loss program	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Feasibility of Primary Care Referrals to Community-based Lifestyle Programs for Management of Obesity
• Actual Study Start Date: Sep 21, 2020
• Actual Primary Completion Date: May 1, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Participants recruited [Through study completion, approximately 28 weeks]

   Total number of participants recruited

2. Participants enrolled [Through study completion, approximately 28 weeks]

   Total number of participants enrolled

3. Participants accrued [Through study completion, approximately 28 weeks]

   Total number of participants accrued

4. Participants to withdrawn or terminate study participation [Through study completion, approximately 28 weeks]

   Total number of participants to withdrawn or terminate study participation

Secondary Outcome Measures

1. Participant satisfaction [At study completion, approximately 28 weeks]

   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.

2. Staff satisfaction [At study completion, approximately 28 weeks]

   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.

3. Change in weight [Baseline, week 16, week 28]

   Change in participant's weight measure in kilograms (kg)

4. Change in Body Mass Index (BMI) [Baseline, week 16, week 28]

   Change in participant's BMI calculated by weight in kilograms divided by the square of height in meters (kg/m2)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Tamim I. Rajjo, M.D., Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04433806
• Other Study ID Numbers: 19-010206
• First Posted: Jun 16, 2020
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of Aug 9, 2022