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

Primary Purpose

Obesity, Lifestyle, Healthy, Community Based Programs

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Referral to weight loss program

About this trial

This is an interventional supportive care trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Participants recruited

Total number of participants recruited

Participants enrolled

Total number of participants enrolled

Participants accrued

Total number of participants accrued

Participants to withdrawn or terminate study participation

Total number of participants to withdrawn or terminate study participation

Secondary Outcome Measures

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.

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.

Change in weight

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

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)

Full Information

NCT ID

NCT04433806

First Posted

June 10, 2020

Last Updated

September 13, 2022

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT04433806

Brief Title

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

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

September 21, 2020 (Actual)

Primary Completion Date

May 1, 2022 (Actual)

Study Completion Date

May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Referral to weight loss program

Intervention Description

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

Primary Outcome Measure Information:

Title

Participants recruited

Description

Total number of participants recruited

Time Frame

Through study completion, approximately 28 weeks

Title

Participants enrolled

Description

Total number of participants enrolled

Time Frame

Through study completion, approximately 28 weeks

Title

Participants accrued

Description

Total number of participants accrued

Time Frame

Through study completion, approximately 28 weeks

Title

Participants to withdrawn or terminate study participation

Description

Total number of participants to withdrawn or terminate study participation

Time Frame

Through study completion, approximately 28 weeks

Secondary Outcome Measure Information:

Title

Participant satisfaction

Description

Time Frame

At study completion, approximately 28 weeks

Title

Staff satisfaction

Description

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.

Time Frame

At study completion, approximately 28 weeks

Title

Change in weight

Description

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

Time Frame

Baseline, week 16, week 28

Title

Change in Body Mass Index (BMI)

Description

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

Time Frame

Baseline, week 16, week 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tamim Rajjo, MD, MPH

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Links:

URL

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

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

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