Fertility, Male Fertility, Sperm Count, Low, Sperm Quality
Conditions
Keywords
EDCs, Endocrine Disrupting Chemicals, Fertility, Sperm Quality, Sperm Count, Male Fertility
Brief summary
The proposed research aims to 1) measure male participants' urinary levels of EDCs and sperm quality before and after report-back and EDC reduction intervention and assess changes, 2) assess the extent to which MM's program (testing, curriculum, and report-back) alters participant environmental health literacy (EHL), readiness to change (RtC), and product/lifestyle choices, and 3) test the feasibility and acceptability of MM's program to male participants. The primary study subjects are adult men of reproductive age. The study aims to have 60 participants complete the study.
Detailed description
The SEED study hypothesizes that our report-back and intervention program will increase environmental health literacy and EDC-reduction behavior, reduce urinary EDCs, and improve semen quality in a sample of US men with low semen quality. And the intervention program will have a larger effect than report-back only. The study will consist of three Aims: 1) Measure male participants' urinary levels of EDCs and semen quality before and after report-back and EDC reduction intervention and assess change. 60 men, with previously established low semen quality, will be recruited from Fellow Health customers (a direct-to-consumer semen testing company). All participants' EDC exposures will be assessed via the MM test kit and receive personalized report-back. Subsequently, in a randomized-controlled trial, 30 participants (i.e. the intervention group) will engage in an 8-session online EDC environmental health literacy curriculum, as well as an online forum and coaching sessions, aimed to increase environmental health literacy and exposure reduction behavior. Thirty participants (i.e. the control group) will receive the report-back only. After completion of the curriculum, participants will retest urinary EDCs. Semen quality at these two time points will also be collected. Differences between the intervention and control groups will be assessed. 2) Assess the extent to which MM's program (testing, curriculum, and report-back) alters participant environmental health literacy, readiness to change, and product/lifestyle choices. Measures of environmental health literacy, willingness/readiness to reduce exposure, exposure reduction behavior, and sources of exposure will be assessed pre- and post-testing/intervention via previously validated surveys, including environmental health literacy and readiness to change (i.e. ready to reduce exposure), and lifestyle audits (including product use, diet, and lifestyle factors). Differences between the intervention and control groups will be assessed. 3) Test the feasibility and acceptability of MM's program to male participants. The usability, feasibility, and overall acceptability of the MM intervention program (i.e. testing, report-back, curriculum, coaching sessions) will be assessed in participants via the System Usability Score and other participant satisfaction questions. Further, focus groups and key informant interviews will be conducted in a subset of participants following the study to gather both qualitative and quantitative information to assess and improve the MM program.
Interventions
BEHAVIORALEDC Education Intervention
Participants receive a 14 module intervention program about endocrine disrupting chemicals and reducing exposures. Participants must complete at least 8 modules over the course of 8 weeks.
Sponsors
Million Marker Wellness, Inc.
Fellow Health, Inc.
National Institute of Environmental Health Sciences (NIEHS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men, * Reproductive Age, * Good Health, * Non-Smoker * English-Speaking * No Occupational/Medical Risks * not using steroids or TRT/hormone replacement supplements * low sperm count=total motile count below 20 million/ml * tested by Fellow in the last 3 months
Exclusion criteria
* Women * Non-Reproductive Age * Poor Health * Smoker * Non-English Speaking * Occupational/Medical Risks * using steroids or TRT/hormone replacement supplements * total motile count over 20 mil/ml, tested by Fellow over 3 months ago
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Environmental Health Literacy | 12-weeks | This surveys assesses EDC-specific environmental health literacy, based on questions in a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree) or 1 (never) to 5 (always). Responses will be reverse coded during analysis as needed so that higher numbers reflect positive outcomes (higher EDC-EHL). |
| Change in Sperm Count | 12 Weeks | Changes measured from Fellow Sperm Test- total motile count at the baseline and post intervention. |
| Change in Readiness to Change | 12 weeks | The Readiness to Change question asks participants to choose the response (sentence) that most accurately describes their current efforts and interest in limiting their exposure to harmful chemicals. Responses will be coded from 1 to 5 with 5 reflecting greater readiness to reduce risky behaviors. |
| Change in Metabolites | 12 weeks | Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sexual Satisfaction (From the International Index of Erectile Function (IIEF) Survey) | 12-weeks | Measured pre and post intervention to Likert style questions from 1 to 5 on overall self reported sexual satisfaction with higher score indicating more satisfied. Two questions taken from validated survey questions from the international index of erectile function survey including "how satisfied have you been with your overall sex life?" https://www.browardurologycenter.com/pdf/International-Index-of-Erectile-Function-IIEF-Questionnaire.pdf |
| Change in Sexual Health Inventory (SHIM) | 12-weeks | Validated survey measured pre and post intervention Add the numbers corresponding to questions 1-5. TOTAL: The Sexual Health Inventory for Men further classifies ED severity with the following breakpoints: 1-7 Severe ED 8-11 Moderate ED 12-16 Mild to Moderate ED 17-21 Mild ED |
| Product Usage | 12 Weeks | Changes in # of reported product usage including personal care, household, and hair products with more products being worse and less products being better. |
| System Usability Score (SUS) | 12-weeks | SUS is a validated survey measuring the usability of the intervention program at the end of intervention. The score is calculated from 0 to 100 with the greater the score indicating better perceived usability. Scores 60 and greater are considered acceptable. |
| Change in Stress | 12-weeks | Change in stress (from validated survey Perceived Stress Scale (PSS-4)). Summarize 4 questions for a score of 0-16. Higher score equals greater stress. |
| Intervention Completion | At the end of intervention (12-weeks) | Number of total modules completed/requirements completed |
| Change in General Health | 12 weeks | Change in self rated general health ( Behavioral Risk Factor Surveillance System (BRFSS)) "In general my health is" from very good to very bad (coded 1 to 5, 5 being very good). These variables are exploratory and may or may not be included in final analysis. |
| Change in Sleep | 12 weeks | Change in sleep (BRFSS- Behavioral Risk Factor Surveillance System), including self reported hours of sleep and sleep quality from very good to very bad(coded 1 to 5, 5 being very good). These variables are exploratory and may or may not be included in final analysis. |
| Change in Physical Activity | 12 Weeks | Change in physical activity (validated survey International Physical Activity Questionnaire (IPAQ)) using calculated MET (Metabolic Equivalent of Task) scores to classify into low, moderate or high physical activity (higher being better). MET score = (how many days × how many minutes × how hard the activity is), added across all activity types." Walking= 3.3 METs Moderate activity=4.0 METs Vigorous activity=8.0 METs These variables are exploratory and may or may not be included in final analysis. |
Countries
United States
Contacts
CONTACTJenna Hua, MPH, PhD
CONTACTChris Ribbens
STUDY_DIRECTORJohanna Rochester, PhD
Million Marker Wellness
Outcome results
None listed