Endocrine Disruptors and Men's Reproductive Health: A Randomized Behavioral Intervention to Increase Environmental Health Literacy and Reduce Exposures Among Men With Low Semen Quality
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Environmental Health Literacy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Non-Reproductive Age
- •Poor Health
- •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
研究组 & 干预措施
Education Intervention
Study participants receive lifestyle audit and educational intervention program in addition to urine and sperm testing.
干预措施: EDC Education Intervention (Behavioral)
Control
Study participants receive urine and sperm testing only.
结局指标
主要结局
Change in Environmental Health Literacy
时间窗: 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
时间窗: 12 Weeks
Changes measured from Fellow Sperm Test- total motile count at the baseline and post intervention.
Change in Readiness to Change
时间窗: 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
时间窗: 12 weeks
Urinary EDC metabolites include bisphenols, phthalates, parabens and oxybenzone.
次要结局
- Change in Sexual Satisfaction (From the International Index of Erectile Function (IIEF) Survey)(12-weeks)
- Change in Sexual Health Inventory (SHIM)(12-weeks)
- Product Usage(12 Weeks)
- System Usability Score (SUS)(12-weeks)
- Change in Stress(12-weeks)
- Intervention Completion(At the end of intervention (12-weeks))
- Change in General Health(12 weeks)
- Change in Sleep(12 weeks)
- Change in Physical Activity(12 Weeks)
研究者
Jenna Hua
Environmental Health Scientist
Million Marker Wellness, Inc.
