NCT04433806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 21, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

1.6 years

First QC Date

June 10, 2020

Last Update Submit

September 13, 2022

Conditions

ObesityLifestyle, HealthyCommunity Based ProgramsPrimary Care Referrals

Outcome Measures

Primary Outcomes (4)

  • 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  • Participants to withdrawn or terminate study participation

    Total number of participants to withdrawn or terminate study participation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 Outcomes (4)

  • Participant satisfaction

    At study completion, approximately 28 weeks

  • Staff satisfaction

    At study completion, approximately 28 weeks

  • Change in weight

    Baseline, week 16, week 28

  • Change in Body Mass Index (BMI)

    Baseline, week 16, week 28

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: Referral to weight loss program

Interventions

Referral to weight loss programBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tamim Rajjo, MD, MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 16, 2020

Study Start

September 21, 2020

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations

US(1)