ObesityNCT04433806
Primary Care Referrals to Community-based Lifestyle Programs for Management of Obesity
A study testing Referral to weight loss program in people with Obesity and Lifestyle, Healthy, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Lifestyle, Healthy, Community Based Programs
- What is being tested?
- Referral to weight loss program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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.
- Being tested
- Referral to weight loss program
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral to weight loss programBehavioural
16 weeks Diabetes Prevention Program based weight loss program at a local community partner
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 25 subjects, all referred to community based program for weight loss at ExercisAbilities Receives: Behavioral: Referral to weight loss program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants recruited
Total number of participants recruited
Measured: Through study completion, approximately 28 weeks
Participants enrolled
Total number of participants enrolled
Measured: Through study completion, approximately 28 weeks
Participants accrued
Total number of participants accrued
Measured: Through study completion, approximately 28 weeks
Participants to withdrawn or terminate study participation
Total number of participants to withdrawn or terminate study participation
Measured: Through study completion, approximately 28 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: At study completion, approximately 28 weeks
Change in weight
Change in participant's weight measure in kilograms (kg)
Measured: 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)
Measured: Baseline, week 16, week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start21 Sep 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamim I. Rajjo, M.D., Mayo Clinic
- Investigators
- Tamim Rajjo, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433806
- Sponsor's protocol ID
- 19-010206
- Status last verified
- Sep 2022
- First submitted
- 10 Jun 2020
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Primary Care Referrals to Community-based Lifestyle Programs for Management of Obesity
- ClinicalTrials.gov ID
- NCT04433806
- Acronym / sponsor ID
- 19-010206
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Referral to weight loss program25 subjects, all referred to community based program for weight loss at ExercisAbilities |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Referral to weight loss program16 weeks Diabetes Prevention Program based weight loss program at a local community partner | Behavioural | Intervention |
Primary outcome
Participants recruited
Time frame: Through study completion, approximately 28 weeks
Total number of participants recruited
Participants enrolled
Time frame: Through study completion, approximately 28 weeks
Total number of participants enrolled
Participants accrued
Time frame: Through study completion, approximately 28 weeks
Total number of participants accrued
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
4 secondary outcomes
Participant satisfaction
Time frame: At study completion, approximately 28 weeks
Staff satisfaction
Time frame: At study completion, approximately 28 weeks
Change in weight
Time frame: Baseline, week 16, week 28
Change in Body Mass Index (BMI)
Time frame: Baseline, week 16, week 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamim Rajjo, MD, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Referral to weight loss program in people with Obesity and Lifestyle, Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants recruited (time frame: Through study completion, approximately 28 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.