Improving Sleep In Midlife Women
ConditionPoor Sleep Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-65
SponsorThe University of Texas Medical Branch, Galveston
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Pregnancy or lactation
including, systemic steroids, anabolic steroids, growth hormone, immunosuppressants, psychotherapy)
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.
Trial design
Design model
Parallel
Treatments tested in this trial
HealthyHabits1
BehavioralParticipants 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
BehavioralParticipants in this group will coached in a one hour session by a study therapist on how to improve sleep habits.
Snack 2
Other interventionParticipants in this group will consume 2 servings of pistachios daily for 30 days
Snack 1
Other interventionParticipants in the group will consume 2 servings of potato chips daily for 30 days.
Treatment groups
72 Participants
are divided into 3 treatment groupsGroup A: Snack 1 + HeathyHabits1Other 2 interventions
Group B: Snack 2 + HealthyHabits2Other 2 interventions
Group C: Snack 2 + HealthyHabits1Other 2 interventions
Trial outcomes
Primary outcomes
1
Change in Pittsburgh Sleep Quality Index (PSQI)
PSQI is a questionnaire that assesses sleep quality, including both subjective experiences and objective parameters. There are 19 questions that are grouped into 7 components to create a global score. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.
Time frame
Baseline, End of intervention period (up to Week 4)Secondary outcomes
1
Change in Seated blood pressure
In-office diastolic and systolic blood pressure will be measured using standard equipment. Blood pressure will be measures in mmHg.
Time frame
Baseline, End of intervention period (up to Week 4)2
Change in Body Weight
Body Weight will be measured using a standardized scale and reported in kg.
Time frame
Baseline, End of intervention period (up to Week 4)3
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance
PROMIS Sleep Disturbance assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. It is an 4-item questionnaire that has participants answer questions about perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep ranked from "not at all" to "always". A higher score indicates more severe sleep issues.
Time frame
Baseline, End of intervention (up to Week 4)4
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment
The PROMIS Sleep Related Impairment questionnaire measures perception of sleepiness during usual awake hours. It is an 4-item questionnaire that has participants answer questions about how sleepiness interfered with their awake-time activities ranked from "not at all" to "always". A higher score indicates greater inference with sleepiness related interference.
Time frame
Baseline, End of intervention period (up to Week 4)Other outcomes
1
Energy intake assessed 3-day food record
Participants will be asked to complete a 3-day food record using ASA24. The three day average energy intake will be calculated.
Time frame
Baseline2
Energy intake assessed by 3-day food record
Participants will be asked to complete a 3-day food record using ASA24. The three day average energy intake will be calculated.
Time frame
End of intervention period (up to Week 4)3
Satisfaction Survey
Treatment Satisfaction Scale is a 11-question measure provided after treatment. It measures participants' perceptions on the treatment's effectiveness, benefits, and influence on quality of life (e.g., improvements in work productivity, mood, etc.). Questions are measured on a 5-point Likert scale from Not at all to Very Much (6 questions) and also include 5 open ended questions.
Time frame
End of intervention period (up to Week 4)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Medical Branch, Galveston
Lead sponsor
American Pistachio Growers
Collaborator
Source ClinicalTrials.gov