Improving Sleep In Midlife Women
Purpose
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.
Condition
- Poor Sleep Quality
Eligibility
- Eligible Ages
- Between 45 Years and 65 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other 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). |
|
|
Other 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. |
|
|
Other 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). |
|
Recruiting Locations
University of Texas Medical Branch
Galveston, Texas 77555
Galveston, Texas 77555
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Medical Branch, Galveston