An interventional study of Exercise instruction with motivational interview and Self-monitoring in Obesity, Physical Activity and Exercise, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2019-01-24.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Prevention
Among 106 studies in Obesity by Mayo Clinic — 17 open to participants now, 24 under way, none of them phase 3. Obesity · Mayo Clinic.
Among the 106 studies in Obesity by Mayo Clinic, this one is the 75th largest by enrollment of the 97 interventional ones that give a count, is one of 7 that started in 2017, is one of 51 with no phase, and was the 64th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →17 of the 106 studies in Obesity by Mayo Clinic are open now, in 1 country. Recruiting first, the newest first:
Mayo Clinic · Sites in United States
Mayo Clinic · Sites in United States
Mayo Clinic · Sites in United States
Mayo Clinic · Sites in United States
Mayo Clinic · Sites in United States
By country, each count listing its studies:
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 18 Years to 59 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
106 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 16 · Phase 2 10 · Phase 3 8 · Phase 4 16
First in 2003; this study’s year is marked. 7 started in 2017.
This study's enrollment of 19 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 32 across the 97 interventional studies, 49 across the 8 observational. Of the 79 that completed or were terminated, 30 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
9 of the studies in Obesity by Mayo Clinic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03866408Mayo ClinicInsulin Regulation of Lipolysis and Lipolysis Proteins | 2026-12-30 |
| NCT07057310Mayo ClinicAging Well: Targeting Obesity With GLP-1 Agonists to Enhance Physical and Vascular Health in Postmenopausal Women | 2026-12-31 |
| NCT04297592Mayo ClinicAntibiotic Prophylaxis in High-Risk Arthroplasty Patients | 2027-01 |
| NCT03238794Mayo ClinicBariatric Surgery Versus Diet Alone in the Bile Acid Pathway and Weight Loss | 2027-01-11 |
| NCT06782529Mayo ClinicKnee Injections for Obese Patients With Knee Arthritis | 2027-01-24 |
Among the 106 studies in Obesity by Mayo Clinic, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Many kinds of wearable technology have become available, but the superiority of those devices in weight loss compared to the standard care without them is uncertain. The possible problems are long-term self-motivation, utility and validity of the device, and outcome measures in clinical trials. The connected health care with motivational interviewing as an intervention, and body composition parameters in addition to body weight as outcome measures are employed in the project. The expected outcome is that connected health care, which is more individualized approach by heath care professionals, is more effective compared to self-monitoring using wearable devices. Two types of wearable device are going to be used to monitor 1) body activity and 2) heart rate variables during exercise which reflect fitness level in this study in order to investigate appropriate monitoring parameters to predict outcome measures.
The hypothesis is that addition of connected health system will result in improvement of body composition and fitness level compared to self-monitoring.
Patients with age 18 to 59 years old and body mass index between 30 to 39.9 are to be enrolled at Mayo Clinic in Arizona. All enrolled subjects receive wearable monitoring devices with remote tracking capability and brochure regarding nutrition and physical exercise with basic instruction. Subjects are randomly assigned to connected health care group versus self-monitoring group. Connected health care group will have 2 interviews about physical exercise and 6 communications with individualized instruction and counseling of their exercise including the usage of the monitoring devices. Self-monitoring group will do physical exercise following the initial basic instruction and self-monitor them.
All subjects visit Mayo Clinic to get outcome measures at 0, 12, and 24weeks. Outcome measures will be compared before, at 12 weeks, and after the 24 weeks of the fitness program.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will get 2 interviews about physical exercise (exercise instruction with motivational interview) and 6 communications with individualized instruction and counseling of their physical exercise (investigators can access activity data and exercise log) including the usage of the monitoring device.
Behavioral: Exercise instruction with motivational interview
This group will do physical exercise following the initial instruction and self-monitor them. Investigators can access activity data and exercise log but will not discuss with the subjects about the data.
Behavioral: Self-monitoring
An activity tracker and a heart rate monitor to track the participants activity and exercise records will be used. In addition to the basic instruction of exercise and nutrition, an exercise physiologist provides individualized exercise instruction with a motivational interviewing skill, which is a different style from traditional persuasive style of communication between the healthcare professionals and patients.
An activity tracker and a heart rate monitor to track the participants activity and exercise records will be used. Basic instruction about exercise and nutrition is provided at the initial visit.
Change in Waist circumference
Waist circumference is measured by tape at the end expiration while the patient is standing. Units centimeters.
Time frame: Baseline and 24 weeks
Change in weight
Weight is measured using a commercially available body weight scale (TANITA body composition monitors). Units kg.
Time frame: Baseline and 24 weeks
Change in body fat percentage
Body fat percentage is measured using a commercially available body fat scale (TANITA body composition monitors). Units percentage.
Time frame: Baseline and 24 weeks
Change in physical activity score
International Physical Activity Questionnaire is filled out by patients. The International Physical Activity Questionnaire Long Form (IPAQ) (www.ipaq.ki.se) is to assess levels and patterns of physical activity. Continuous score expressed as "MET (metabolic equivalent)-min/week: MET level\*minutes of activity/day\*days per week" is calculated. Higher number means higher level of physical activity that a subject performed during last 7 days. The estimated range is from 0 to 3000. Units MET-minutes.
Time frame: Baseline and 24 weeks
Change in Physical Activity Vital Sign
Physical Activity Vital Sign (PAVS) (Greenwood JL, 2010) is a short physical activity assessment using closed ended questions to ask how many days a subject performed physical activity during the past week. Higher number means a subject spent more days on performing physical activity. The range is from 0 to 7. Units days.
Time frame: Baseline and 24 weeks
Change in Veterans Specific Activity Questionnaire
Veterans Specific Activity Questionnaire (VASQ) (Myers J, 2001) is a brief self administered questionnaire to predict exercise capacity (METs, metabolic equivalents). A subject select the minimum activity level that cause fatigue, short of breath, or discomfort. Higher number means higher fitness level of a subject. the range is from 1 to 13. Units METs.
Time frame: Baseline and 24 weeks
Change in heart rate variables
Heart rate recovery after 6 minute walk test is evaluated. Units beats/minute.
Time frame: Baseline and 24 weeks
Change in 6 minute walk test
Walking distance is evaluated. Units meters.
Time frame: Baseline and 24 weeks
Ran from Dec 2017 to primary completion in Aug 2018, 8 months.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 8 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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