Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
72 participants
INTERVENTIONAL
2026-01-15
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Snack 1 + HeathyHabits1
Participants in this arm will consume 2 servings of potato chips per day for 30 days. They will also meet once with a study therapist for discussion and suggestions to improve healthy habits (e.g.,diet/nutrition, activity, sleep).
HealthyHabits1
Participants in this group will be coached in a one hour session with a study therapist how to improve healthy habits (e.g.,diet/nutrition, activity, sleep).
Snack 1
Participants in the group will consume 2 servings of potato chips daily for 30 days.
Snack 2 + HealthyHabits2
Participants in this arm will consume 2 servings of pistachios for 30 days. They will also meet once with a study therapist for discussion and suggestions to improve sleep habits.
HealthyHabits2
Participants in this group will coached in a one hour session by a study therapist on how to improve sleep habits.
Snack 2
Participants in this group will consume 2 servings of pistachios daily for 30 days
Snack 2 + HealthyHabits1
Participants in this arm will consume 2 servings of pistachios per day for 30 days. They will also meet once with a study therapist for discussion and suggestions to improve healthy habits (e.g.,diet/nutrition, activity, sleep).
HealthyHabits1
Participants in this group will be coached in a one hour session with a study therapist how to improve healthy habits (e.g.,diet/nutrition, activity, sleep).
Snack 2
Participants in this group will consume 2 servings of pistachios daily for 30 days
Interventions
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HealthyHabits1
Participants in this group will be coached in a one hour session with a study therapist how to improve healthy habits (e.g.,diet/nutrition, activity, sleep).
HealthyHabits2
Participants in this group will coached in a one hour session by a study therapist on how to improve sleep habits.
Snack 2
Participants in this group will consume 2 servings of pistachios daily for 30 days
Snack 1
Participants in the group will consume 2 servings of potato chips daily for 30 days.
Eligibility Criteria
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Inclusion Criteria
* Between the ages of 45-65 years old
* Women who meet STRAW staging criteria for late peri-menopause (STRAW score of -1) defined as interval of amenorrhea of 60 days OR meet STRAW staging criteria for early post-menopause (STRAW score of +1a, +1b or +1c) defined as \>12 months since last menstrual period
* History of poor sleep quality (Pittsburgh Sleep Quality Index score \> 5)
* Able and willing to provide informed consent
* Access to an electronic device with teleconferencing capabilities (Teams, etc)
* Willing to consume study intervention
* Fluent (able to read and write) in English
Exclusion Criteria
* Recent (within the last 3 months) or current use of any prescription or over the counter medications that may impact sleep quality:
1. including, systemic steroids, anabolic steroids, growth hormone, immunosuppressants, psychotherapy)
2. recent (within the last 3 months) change in antidepressant medication useage or dosage
* Untreated comorbid sleep disorders that are no known to be responsive to the behavioral interventions: These sleep disorders include but are not limited to narcolepsy, circadian rhythm disorder/shift work, restless leg syndrome, periodic leg movement disorder, obstructive sleep apnea.
* Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in past 3 years) that would, in the opinion of the investigator, affect sleep and/or make it difficult for the participant to the investigators instructions.
* Recent (within past 3 years) treated cancer other than basal cell carcinoma
* Current adherence to a weight-loss or weight-gain diet or use of GLP-1 RA medications
* Active or recent (within the past 12 months) alcohol or substance use disorder
* Allergy to study intervention (tree nuts)
* Any other condition or event considered exclusionary by study PI
45 Years
65 Years
FEMALE
No
Sponsors
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American Pistachio Growers
OTHER
The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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Emily Lantz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Locations
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University of Texas Medical Branch
Galveston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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25-0194
Identifier Type: -
Identifier Source: org_study_id
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