Trial Outcomes & Findings for An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis (NCT NCT04259788)
NCT ID: NCT04259788
Last Updated: 2026-04-13
Results Overview
Pain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
COMPLETED
NA
109 participants
Baseline to 12 weeks
2026-04-13
Participant Flow
Tailored, adaptive social media advertisements were developed and implemented by BuildClinical, LLC, and the Fred Hutch Marketing and Communications Social Media Team. Flyers/brochures were distributed at local and national organizations. Participants were also recruited from Kaiser Permanente Washington (KPW). Potentially eligible KPW members aged 18-45 years were identified using Kaiser Permanente Washington Health Research Institute (KPWHRI) electronic administrative and clinical data.
Participant milestones
| Measure |
Intervention
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines. Participants in this arm will be asked to consume this diet for a 12-week period. During the first 4 weeks meals and snacks will be shipped to the participant. During the last 8 weeks of the intervention, the study will provide the participants with a 14-day meal plan (3 meals and 2 snacks) that adheres to the AHEI maximum score criteria to help facilitate adherence to the diet.
|
Control
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
58
|
|
Overall Study
COMPLETED
|
36
|
43
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
Reasons for withdrawal
| Measure |
Intervention
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines. Participants in this arm will be asked to consume this diet for a 12-week period. During the first 4 weeks meals and snacks will be shipped to the participant. During the last 8 weeks of the intervention, the study will provide the participants with a 14-day meal plan (3 meals and 2 snacks) that adheres to the AHEI maximum score criteria to help facilitate adherence to the diet.
|
Control
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
15
|
Baseline Characteristics
An AHEI Dietary Intervention to Reduce Pain in Women With Endometriosis
Baseline characteristics by cohort
| Measure |
Control
n=58 Participants
Participants in this arm will not receive the dietary intervention.
|
Intervention
n=48 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines. Participants in this arm will be asked to consume this diet for a 12-week period. During the first 4 weeks meals and snacks will be shipped to the participant. During the last 8 weeks of the intervention, the study will provide the participants with a 14-day meal plan (3 meals and 2 snacks) that adheres to the AHEI maximum score criteria to help facilitate adherence to the diet.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.1 years
STANDARD_DEVIATION 6.2 • n=193 Participants
|
32.8 years
STANDARD_DEVIATION 8.1 • n=193 Participants
|
32.8 years
STANDARD_DEVIATION 6.2 • n=386 Participants
|
|
Sex/Gender, Customized
Female
|
58 Participants
n=193 Participants
|
48 Participants
n=193 Participants
|
106 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
White
|
44 Participants
n=193 Participants
|
34 Participants
n=193 Participants
|
78 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
5 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
9 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Multiple races
|
4 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
9 Participants
n=386 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
2 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
6 Participants
n=386 Participants
|
|
Baseline acyclic pelvic pain
|
7.0 units on a scale
STANDARD_DEVIATION 2.6 • n=193 Participants
|
7.1 units on a scale
STANDARD_DEVIATION 3.0 • n=193 Participants
|
7.0 units on a scale
STANDARD_DEVIATION 2.8 • n=386 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksPain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
Outcome measures
| Measure |
Intervention
n=48 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=58 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Pain Measurement - Acyclic Pain
Baseline
|
7.1 VAS pain score
95% Confidence Interval 3.0 • Interval 6.3 to 7.9
|
7.0 VAS pain score
95% Confidence Interval 2.6 • Interval 6.2 to 7.7
|
|
Pain Measurement - Acyclic Pain
12-weeks
|
4.7 VAS pain score
Interval 3.8 to 5.6
|
6.7 VAS pain score
Interval 5.9 to 7.5
|
PRIMARY outcome
Timeframe: BaselinePain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).
Outcome measures
| Measure |
Intervention
n=48 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=58 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Pain Measurement - Pain Catastrophizing
|
24.3 Pain catastrophizing score
95% Confidence Interval 20.7 • Interval 20.7 to 27.9
|
25.5 Pain catastrophizing score
95% Confidence Interval 22.2 • Interval 22.2 to 28.8
|
PRIMARY outcome
Timeframe: BaselinePain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.
Outcome measures
| Measure |
Intervention
n=48 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=58 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Pain Measurement - Pills
|
16.4 Pain pills per week
Interval 11.5 to 21.2
|
17.4 Pain pills per week
Interval 13.0 to 21.8
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksQOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Outcome measures
| Measure |
Intervention
n=48 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=58 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Quality of Life EHP-30
Baseline
|
58.2 score on a scale
Interval 53.8 to 62.7
|
61.8 score on a scale
Interval 57.8 to 65.9
|
|
Quality of Life EHP-30
12 weeks
|
36.7 score on a scale
Interval 30.1 to 43.2
|
51.5 score on a scale
Interval 45.6 to 57.4
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksMental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Outcome measures
| Measure |
Intervention
n=48 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=58 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Quality of Life SF-12 MC
Baseline
|
37.7 score on a scale
Interval 35.5 to 40.0
|
35.9 score on a scale
Interval 33.8 to 38.0
|
|
Quality of Life SF-12 MC
12 weeks
|
42.3 score on a scale
Interval 39.4 to 45.2
|
38.8 score on a scale
Interval 36.2 to 41.4
|
PRIMARY outcome
Timeframe: BaselinePhysical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Outcome measures
| Measure |
Intervention
n=48 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=58 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Quality of Life SF-12 PC
|
41.1 score on a scale
Interval 38.6 to 43.6
|
41.8 score on a scale
Interval 39.5 to 44.1
|
PRIMARY outcome
Timeframe: BaselineMeasurement of circulating levels of inflammatory markers (interleukin (IL)-6) with SomaScan
Outcome measures
| Measure |
Intervention
n=5 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=12 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Inflammatory Markers
|
243.6 relative fluorescence units (RFU)
Interval 207.0 to 280.2
|
235.9 relative fluorescence units (RFU)
Interval 212.3 to 259.6
|
PRIMARY outcome
Timeframe: BaselineMeasurement of circulating levels of high sensitivity-C-reactive protein with SomaScan
Outcome measures
| Measure |
Intervention
n=5 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=12 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Protein Measurement
|
43421 relative fluorescence units (RFU)
Interval 13720.0 to 73122.0
|
42929 relative fluorescence units (RFU)
Interval 23757.0 to 62101.0
|
PRIMARY outcome
Timeframe: BaselineMeasurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 with SomaScan
Outcome measures
| Measure |
Intervention
n=12 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=5 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Tumor Necrosis Factor Measurement
|
8270.7 relative fluorescence units (RFU)
Interval 6920.6 to 9620.7
|
7542.2 relative fluorescence units (RFU)
Interval 5450.7 to 9633.8
|
PRIMARY outcome
Timeframe: BaselineMeasurement of circulating levels of soluble TNF alpha-receptor 2 with SomaScan
Outcome measures
| Measure |
Intervention
n=5 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=12 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Tumor Necrosis Factor Measurement #2
|
1517.6 relative fluorescence units (RFU)
Interval 1088.4 to 1964.8
|
1584.7 relative fluorescence units (RFU)
Interval 1307.77 to 1861.8
|
PRIMARY outcome
Timeframe: Week 4Pain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
Outcome measures
| Measure |
Intervention
n=40 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=48 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Pain Measurement - Acyclic Pain
|
6.3 score on a scale
Interval 5.5 to 7.1
|
6.9 score on a scale
Interval 6.2 to 7.7
|
PRIMARY outcome
Timeframe: Week 4Pain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).
Outcome measures
| Measure |
Intervention
n=40 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=48 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Pain Measurement - Pain Catastrophizing
|
16.7 pain catastrophizing score
Interval 13.0 to 20.3
|
23.0 pain catastrophizing score
Interval 19.7 to 26.2
|
PRIMARY outcome
Timeframe: Week 4Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.
Outcome measures
| Measure |
Intervention
n=41 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=50 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Pain Measurement - Pills
|
12.4 Pain pills per week
Interval 8.4 to 16.5
|
15.1 Pain pills per week
Interval 11.5 to 18.7
|
PRIMARY outcome
Timeframe: Week 4QOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Outcome measures
| Measure |
Intervention
n=40 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=48 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Quality of Life EHP-30
|
39.3 score on a scale
Interval 34.1 to 44.5
|
56.0 score on a scale
Interval 51.3 to 60.7
|
PRIMARY outcome
Timeframe: Week 4Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Outcome measures
| Measure |
Intervention
n=40 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=48 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Quality of Life SF-12 PC
|
44.8 score on a scale
Interval 41.9 to 47.6
|
41.2 score on a scale
Interval 38.6 to 43.8
|
PRIMARY outcome
Timeframe: Week 4Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Outcome measures
| Measure |
Intervention
n=40 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=48 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Quality of Life SF-12 MC
|
42.2 score on a scale
Interval 39.8 to 44.5
|
38.3 score on a scale
Interval 36.2 to 40.5
|
PRIMARY outcome
Timeframe: Week 4Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 with SomaScan
Outcome measures
| Measure |
Intervention
n=5 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=9 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Inflammatory Markers
|
243.8 relative fluorescence units (RFU)
Interval 217.7 to 269.8
|
232.2 relative fluorescence units (RFU)
Interval 214.8 to 249.7
|
PRIMARY outcome
Timeframe: Week 4Measurement of circulating levels of high sensitivity-C-reactive protein with SomaScan
Outcome measures
| Measure |
Intervention
n=5 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=9 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Protein Measurement
|
34550 relative fluorescence units (RFU)
Interval 5808.6 to 63292.0
|
35078 relative fluorescence units (RFU)
Interval 16323.0 to 53833.0
|
PRIMARY outcome
Timeframe: Week 4Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan
Outcome measures
| Measure |
Intervention
n=5 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=9 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Tumor Necrosis Factor Measurement
|
7528.1 relative fluorescence units (RFU)
Interval 6227.7 to 8828.5
|
7853.3 relative fluorescence units (RFU)
Interval 6923.1 to 8782.4
|
PRIMARY outcome
Timeframe: Week 4Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan
Outcome measures
| Measure |
Intervention
n=5 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=9 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Tumor Necrosis Factor Measurement #2
|
1474.3 relative fluorescence units (RFU)
Interval 1189.4 to 1759.3
|
1511.4 relative fluorescence units (RFU)
Interval 1300.0 to 1722.1
|
PRIMARY outcome
Timeframe: Week 8Pain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
Outcome measures
| Measure |
Intervention
n=36 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=45 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Pain Measurement - Acyclic Pelvic Pain
|
5.5 VAS pain score
Interval 4.6 to 6.4
|
6.2 VAS pain score
Interval 5.4 to 7.0
|
PRIMARY outcome
Timeframe: Week 8Pain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).
Outcome measures
| Measure |
Intervention
n=37 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=45 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Pain Measurement - Pain Catastrophizing Score
|
14.2 pain catastrophizing score
Interval 10.2 to 18.2
|
21.7 pain catastrophizing score
Interval 18.1 to 24.4
|
PRIMARY outcome
Timeframe: Week 8Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.
Outcome measures
| Measure |
Intervention
n=37 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=48 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Pain Measurement - Pills
|
11.9 Pain pills per week
Interval 8.3 to 15.5
|
12.7 Pain pills per week
Interval 9.5 to 15.9
|
PRIMARY outcome
Timeframe: Week 8QOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Outcome measures
| Measure |
Intervention
n=36 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=45 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Quality of Life EHP-30
|
37.7 score on a scale
Interval 31.7 to 43.7
|
52.2 score on a scale
Interval 46.8 to 57.5
|
PRIMARY outcome
Timeframe: Week 8Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Outcome measures
| Measure |
Intervention
n=37 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=46 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Quality of Life SF-12 PC
|
46.1 score on a scale
Interval 43.2 to 48.9
|
43.3 score on a scale
Interval 40.7 to 45.8
|
PRIMARY outcome
Timeframe: Week 8Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Outcome measures
| Measure |
Intervention
n=37 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=46 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Quality of Life SF-12 MC
|
42.1 score on a scale
Interval 39.6 to 44.5
|
36.2 score on a scale
Interval 34.0 to 38.4
|
PRIMARY outcome
Timeframe: Week 8Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan
Outcome measures
| Measure |
Intervention
n=3 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=8 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Inflammatory Markers
|
267.7 relative fluorescence units (RFU)
Interval 211.3 to 323.9
|
227.4 relative fluorescence units (RFU)
Interval 190.6 to 264.2
|
PRIMARY outcome
Timeframe: Week 8Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan
Outcome measures
| Measure |
Intervention
n=3 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=8 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Protein Measurement
|
31649 relative fluorescence units (RFU)
Interval 1199.4 to 62098.0
|
34127 relative fluorescence units (RFU)
Interval 14924.0 to 53425.0
|
PRIMARY outcome
Timeframe: Week 8Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan
Outcome measures
| Measure |
Intervention
n=3 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=8 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Tumor Necrosis Factor Measurement
|
8429.8 relative fluorescence units (RFU)
Interval 5578.1 to 11282.0
|
8136.6 relative fluorescence units (RFU)
Interval 6306.3 to 9966.9
|
PRIMARY outcome
Timeframe: Week 8Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan
Outcome measures
| Measure |
Intervention
n=3 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=8 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Tumor Necrosis Factor Measurement #2
|
1694.3 relative fluorescence units (RFU)
Interval 1184.1 to 2204.4
|
1591 relative fluorescence units (RFU)
Interval 1258.0 to 1924.0
|
PRIMARY outcome
Timeframe: Week 12Pain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
Outcome measures
| Measure |
Intervention
n=36 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=43 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Pain Measurement - Acyclic Pelvic Pain
|
4.7 score on a scale
Interval 3.8 to 5.6
|
6.7 score on a scale
Interval 5.9 to 7.5
|
PRIMARY outcome
Timeframe: Week 12Pain will be measured with components of the EPHect participant questionnaire using the pain catastrophizing scale. Scores range from 0 to 52, higher scores indicate a greater amount of catastrophizing (worse).
Outcome measures
| Measure |
Intervention
n=36 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=43 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Pain Measurement - Pain Catastrophizing Score
|
13.6 pain catastrophizing score
Interval 9.5 to 17.7
|
21.3 pain catastrophizing score
Interval 17.6 to 25.0
|
PRIMARY outcome
Timeframe: Week 12Pain will be measured with components of the EPHect participant questionnaire using the mean number of analgesic and/or opioid pills taken per week.
Outcome measures
| Measure |
Intervention
n=38 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=45 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Pain Measurement - Pills
|
12.2 Pain pills per week
Interval 8.8 to 15.6
|
12.4 Pain pills per week
Interval 9.3 to 15.5
|
PRIMARY outcome
Timeframe: Week 12QOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Outcome measures
| Measure |
Intervention
n=36 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=43 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Quality of Life EHP-30
|
36.7 score on a scale
Interval 30.1 to 43.2
|
51.5 score on a scale
Interval 45.6 to 57.4
|
PRIMARY outcome
Timeframe: Week 12Physical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Outcome measures
| Measure |
Intervention
n=36 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=43 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Quality of Life SF-12 PC
|
45.5 score on a scale
Interval 42.9 to 48.1
|
43.4 score on a scale
Interval 41.1 to 45.8
|
PRIMARY outcome
Timeframe: Week 12Mental QOL will be measured with the SF-12 Mental Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Outcome measures
| Measure |
Intervention
n=36 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=43 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Quality of Life SF-12 MC
|
42.3 score on a scale
Interval 39.4 to 45.2
|
38.8 score on a scale
Interval 36.2 to 41.4
|
PRIMARY outcome
Timeframe: Week 12Measurement of circulating levels of inflammatory markers (interleukin (IL)-6 from SomaScan
Outcome measures
| Measure |
Intervention
n=4 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=7 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Inflammatory Markers
|
236.0 relative fluorescence units (RFU)
Interval 181.8 to 290.3
|
228.6 relative fluorescence units (RFU)
Interval 181.8 to 290.3
|
PRIMARY outcome
Timeframe: Week 12Measurement of circulating levels of high sensitivity-C-reactive protein from SomaScan
Outcome measures
| Measure |
Intervention
n=4 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=7 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Protein Measurement
|
33287 relative fluorescence units (RFU)
Interval 4128.5 to 62446.0
|
34894 relative fluorescence units (RFU)
Interval 15707.0 to 54080.0
|
PRIMARY outcome
Timeframe: Week 12Measurement of circulating levels of soluble tumor necrosis factor (TNF) alpha-receptor 1 from SomaScan
Outcome measures
| Measure |
Intervention
n=4 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=7 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Tumor Necrosis Factor Measurement
|
7136.3 relative fluorescence units (RFU)
Interval 4808.0 to 9464.6
|
7503.6 relative fluorescence units (RFU)
Interval 5826.5 to 9180.8
|
PRIMARY outcome
Timeframe: Week 12Measurement of circulating levels of soluble TNF alpha-receptor 2 from SomaScan
Outcome measures
| Measure |
Intervention
n=4 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=7 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Tumor Necrosis Factor Measurement #2
|
1531.6 relative fluorescence units (RFU)
Interval 981.2 to 2082.1
|
1677 relative fluorescence units (RFU)
Interval 1314.4 to 2040.1
|
SECONDARY outcome
Timeframe: 6 monthsPain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
Outcome measures
| Measure |
Intervention
n=32 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=33 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Pain Measurement - Acyclic Pelvic Pain
|
5 VAS pain score
Standard Deviation 3
|
5 VAS pain score
Standard Deviation 3
|
SECONDARY outcome
Timeframe: 12 monthsPain will be measured with components of the EPHect participant questionnaire using the VAS pain score. Scores range from 0 to 10, higher score is more pain (worse).
Outcome measures
| Measure |
Intervention
n=25 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=28 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Pain Measurement - Acyclic Pelvic Pain
|
4 VAS pain score
Standard Deviation 3
|
5 VAS pain score
Standard Deviation 3
|
SECONDARY outcome
Timeframe: 6 monthsQOL will be measured with the Endometriosis Health Profile Questionnaire. Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Outcome measures
| Measure |
Intervention
n=32 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=33 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Quality of Life EHP-30
|
40 score on a scale
Standard Deviation 20
|
48 score on a scale
Standard Deviation 26
|
SECONDARY outcome
Timeframe: 12 monthsPhysical QOL will be measured with the SF-12 Physical Component Summary (MCS). Scores range from 0 to 100, higher scores reflect more symptoms and worse health status.
Outcome measures
| Measure |
Intervention
n=25 Participants
The intervention group will receive in-person dietary counseling from a registered dietitian to help participants consume a diet that is consistent the AHEI dietary guidelines.
|
Control
n=28 Participants
Participants in this arm will not receive the dietary intervention.
|
|---|---|---|
|
Quality of Life SF-12 PC
|
31 score on a scale
Standard Deviation 21
|
44 score on a scale
Standard Deviation 30
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place