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The purpose of this research is to gather preliminary information on the effectiveness of Low Level Laser Therapy (LLLT) in helping people reduce their weight gain in the central body region.
This will be an open label clinical trial with all study participants receiving LLLT. Preliminary data will be collected on the efficacy of LLLT based on varying frequency of treatments. The focus of this study on 60 overweight adults with a BMI of 25 to 29.9, and assess changes in weight and waist circumference at end of treatment for group 1 (week 4) and group 2 (week 6) and group 3 (week 12). Participants will be randomized to receive LLLT treatments either 3 times a week; 2 times a week; or once a week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser for 4 weeks | Active Comparator | 3 Low-Level Laser Therapy Treatments Weekly |
|
| Laser for 6 weeks | Active Comparator | 2 Low-Level Laser Therapy Treatments Weekly |
|
| Laser for 12 weeks | Active Comparator | 1 Low-Level Laser Therapy Treatment Weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 Low-Level Laser Therapy Treatments Weekly | Device | Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Comparison of weight change from baseline between arms | baseline and 4 weeks |
| Change in Waist Circumference | Comparison of waist circumference change from baseline between arms | baseline and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivana T Croghan, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31473867 | Result | Croghan IT, Hurt RT, Schroeder DR, Fokken SC, Jensen MD, Clark MM, Ebbert JO. Low-level laser therapy for weight reduction: a randomized pilot study. Lasers Med Sci. 2020 Apr;35(3):663-675. doi: 10.1007/s10103-019-02867-5. Epub 2019 Aug 31. |
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After consent, patients were screened for study entry criteria. Only those who passed all criteria were invited to be randomized to study.
Participants recruited from the local community of Rochester, MN, 09/16-08/17. All interested individuals called a central number and underwent a 10-minute phone pre-screen. If they passed the telephone pre-screen, they were invited to attend an in-person consent visit. All study visits and treatments took place in Mayo Clinic - Rochester Campus.
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| ID | Title | Description |
|---|---|---|
| FG000 | Laser for 4 Weeks | 3 Low-Level Laser Therapy Treatments Weekly 3 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks |
| FG001 | Laser for 6 Weeks | 2 Low-Level Laser Therapy Treatments Weekly 2 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks |
| FG002 | Laser for 12 Weeks | 1 Low-Level Laser Therapy Treatment Weekly 1 Low-Level Laser Therapy Treatment Weekly: Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laser for 4 Weeks | 3 Low-Level Laser Therapy Treatments Weekly 3 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks |
| BG001 | Laser for 6 Weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Weight | Comparison of weight change from baseline between arms | Posted | Mean | Standard Deviation | Kg | baseline and 4 weeks |
|
Adverse events were collected during LLLT treatment for each group (4 weeks for group A; 6 weeks for group B; 12 weeks for group C).
All Adverse Events that met criteria for being Serious Adverse Events were recorded and followed up; In addition, adverse events not meeting SAE criteria and considered to be potentially related to the LLLT were also documented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laser for 4 Weeks | 3 Low-Level Laser Therapy Treatments Weekly 3 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Pregnancy - not considered related to treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ivana Croghan | Mayo Clinic | 507-266-1944 | nicotineresearch@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2016 | Aug 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 2 Low-Level Laser Therapy Treatments Weekly | Device | Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks |
|
| 1 Low-Level Laser Therapy Treatment Weekly | Device | Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks |
|
2 Low-Level Laser Therapy Treatments Weekly
2 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks
| BG002 | Laser for 12 Weeks | 1 Low-Level Laser Therapy Treatment Weekly 1 Low-Level Laser Therapy Treatment Weekly: Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Weight (kg) | Mean | Standard Deviation | Kg |
|
| Waist Circumference (cm) | Mean | Standard Deviation | cm |
|
1 Low-Level Laser Therapy Treatment Weekly 1 Low-Level Laser Therapy Treatment Weekly: Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks |
|
|
|
| Primary | Change in Waist Circumference | Comparison of waist circumference change from baseline between arms | Posted | Mean | Standard Deviation | cm | baseline and 4 weeks |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Laser for 6 Weeks | 2 Low-Level Laser Therapy Treatments Weekly 2 Low-Level Laser Therapy Treatments Weekly: Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Laser for 12 Weeks | 1 Low-Level Laser Therapy Treatment Weekly 1 Low-Level Laser Therapy Treatment Weekly: Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks | 0 | 20 | 1 | 20 | 0 | 20 |
|
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