Improving Sleep In Midlife Women

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Poor Sleep Quality

Treatments: Other: Snack 1; Behavioral: HealthyHabits1; Other: Snack 2; Behavioral: HealthyHabits2

Study type: Interventional

Funder types: Other

Identifiers

NCT07337915

25-0194

Details and patient eligibility

About

This study purpose of this study to see how consuming pistachios and completing a health intervention session a study therapist may improve sleep health in midlife women with poor sleep. Participants in this study will be asked to consume a study snack for about one month, complete a health education session with a study therapist and record information about their sleep. At baseline and after the intervention we will collect information about sleep, alertness, body composition, and blood lipids.

Enrollment: 72 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All races and ethnic backgrounds
• 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

• Pregnancy or lactation

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 3 patient groups

Snack 1 + HeathyHabits1

Other group

Description:

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).

Treatment:

Behavioral: HealthyHabits1

Other: Snack 1

Snack 2 + HealthyHabits2

Other group

Description:

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.

Treatment:

Other: Snack 2

Behavioral: HealthyHabits2

Snack 2 + HealthyHabits1

Other group

Description:

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).

Treatment:

Other: Snack 2

Behavioral: HealthyHabits1