P20 Extending Sleep to Reverse Metabolic Syndrome in Middle-Aged Adults: Acceptability and Feasibility of a Sleep Intervention

This pilot study will test the acceptability and feasibility of a sleep extension intervention in community-dwelling, short-sleeping, racially/ethnically diverse middle-aged adults with MetS. Baseline sleep habits will be assessed and used to guide individualized strategies to extend sleep. A 1-group pretest-posttest study design will test the efficacy of this 18-week study (2 weeks of baseline data collection, 1 week of study intervention planning, 12 weeks of sleep intervention delivery, final follow up 3 weeks after last day of the 12-week intervention) on sleep duration, MetS risk behaviors (reduced physical activity, increased sedentary behavior, poor diet quality), symptoms associated with MetS risk behaviors (poor affective well-being, fatigue), and self-regulation. Socio-ecological barriers and facilitators to the intervention will be identified using a quantitative and qualitative approac

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: Sleep Intervention; Behavioral: Week 2 Intervention

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • New York University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Greater than or equal to 35 years of age and less than or equal to 60 years of age. Middle aged adults have the highest prevalence of short sleep compared to other stages of adulthood.
• Objectively confirmed MetS defined by three or more of the following: a) waist circumference greater than 120cm (men) or 88cm (women), b) blood pressure greater than or equal to 135 mmHg systolic or greater than or equal to 85 mmHg diastolic or antihypertensive medication use, c) fasting glucose greater than or equal to 110 mg/dL or insulin or oral hypoglycemic medication use, d) serum triglycerides greater than or equal to 150mg/dL or hypertriglyceride medication use, e) HDL-c less than 40mg/dL (women) or less than 50 mg/dL (men) or medication use for low HDL-c1. MetS was selected because individuals with MetS are at high risk for multiple chronic conditions.
• Accelerometry confirmed short sleep (average work day sleep less than or equal to 6.5 hours/night). Self-reported sleep may overestimate sleep duration. This will ensure that participants will have short sleep patterns that are associated with MetS outcomes.
• English speaking. Participants will need to demonstrate adequate English comprehension (assessed during informed consent).

Exclusion Criteria:

• Pregnancy/lactation (self-reported). Pregnancy and lactation can disrupt habitual sleep patterns, and hormonal changes during pregnancy increase insulin resistance and may confound MetS.
• Current chemotherapy treatments (self-reported). Current chemotherapy treatments may contribute to fatigue and sleep disturbances.
• Alcohol abuse/dependence will be assessed with the Alcohol Use Disorders Identification Test (a measure that has demonstrated good reliability and validity). Alcohol abuse/dependence may contribute to sleep disturbances and limit the participant's ability to take part in sleep interventions.
• Night shift or shift work (previous 2 months), trans-meridian travel (previous 4 weeks), or planned shift work or trans-meridian travel during intervention period (self-reported). These will be to ensure that sleep estimates from baseline represent participants' habitual sleep and to ensure adherence with the sleep intervention.
• Moderate-severe or severe depression will be assessed with the PHQ-9. Moderate-severe depression or severe depression may contribute to sleep disturbances and interfere with the participant's ability to adhere to the sleep interventions.
• Chronic use of sleep-promoting medications (self-reported). These may interfere with sleep patterns and limit the participant's ability to take part in the sleep interventions.
• Habitual napping, defined as 2 naps per day or > 90 minutes of napping on 3 or more days of the week will be assessed during baseline with accelerometry. This will be to ensure adherence with the sleep intervention.
• Diagnosed but untreated obstructive sleep apnea.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Short Sleep Patients

Behavioral: Sleep Intervention; Sleep Diaries (Daily); Fitbit 24/7; Phone/ video conference calls (weekly with study team); Epworth Sleepiness Scale (weekly); PROMIS fatigue scale-evening (weekly); Behavioral: Week 2 Intervention; Sleep Diaries (Daily); Phone Calls (weekly with study team); Wrist Accelerometry and fitbit 24/7 for 14 days; SAFTEE Questionnaire; ASA24; Behavioral risk factor surveillance system (smoking and alcohol use questions); Psychological well-being (SF36); Index of Self Regulation; PROMIS fatigue scale-morning (weekly); PROMIS fatigue scale-evening (weekly); Epworth Sleepiness Scale (weekly)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of participants rating SASI	acceptable (overall acceptability survey scores greater than 21),neutral (overall acceptability survey scores equal to 21), and unacceptable (overall acceptability survey scores less than 21) at each of two time points (pre-intervention and post intervention).	18 Weeks
Recruitment rate measured by the percentage of potential participants screened in order to enroll 30 participants		18 Weeks
Attrition rate measured by the percentage of enrolled participants completing the 15-week intervention		18 Weeks
Protocol adherence rates measured by the percentage of participants completing greater than or equal to 4 daily sleep diary entries per week for 80% or more of the intervention period.		18 Weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Susan Malone, MD, New York Langone Medical Center

Publications and helpful links

General Publications

• Wright F, Malone SK, Wong A, D'Eramo Melkus G, Dickson VV. Addressing Challenges in Recruiting Diverse Populations for Research: Practical Experience From a P20 Center. Nurs Res. 2022 May-Jun 01;71(3):218-226. doi: 10.1097/NNR.0000000000000577. Epub 2022 Jan 24.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2019
• Primary Completion (Actual): June 4, 2021
• Study Completion (Actual): June 4, 2021

Study Registration Dates

• First Submitted: July 12, 2018
• First Submitted That Met QC Criteria: July 12, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: hypertension; type 2 diabetes; metabolic syndrome; dyslipidemia; abdominal obesity; sleep intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 18-00707

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No