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OpenTrials
Completed

NCT Number: NCT04433806

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.

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Referral to weight loss program

Behavioral

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

Primary outcomes

  1. Participants recruited

    Time frame: Through study completion, approximately 28 weeks

    Total number of participants recruited

  2. Participants enrolled

    Time frame: Through study completion, approximately 28 weeks

    Total number of participants enrolled

  3. Participants accrued

    Time frame: Through study completion, approximately 28 weeks

    Total number of participants accrued

  4. Participants to withdrawn or terminate study participation

    Time frame: Through study completion, approximately 28 weeks

    Total number of participants to withdrawn or terminate study participation

Secondary outcomes

  1. Participant satisfaction

    Time frame: 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

    Time frame: 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

    Time frame: Baseline, week 16, week 28

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

  4. Change in Body Mass Index (BMI)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2020
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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