P20 Extending Sleep to Reverse Metabolic Syndrome

NCT03596983 | Completed Results

• 1 other identifier: 18-00707
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolic Syndrome

Keywords

sleep intervention; metabolic syndrome; hypertension; type 2 diabetes; abdominal obesity; dyslipidemia

Outcome Measures

Primary Outcomes (5)

• SASI Acceptability Questionnaire Score at Pre-Intervention

  14-item questionnaire assessing acceptability of SASI. Items are ranked on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is the average item score and ranges from 1-5. Higher total scores indicate greater overall acceptability.

  Baseline

• SASI Acceptability Questionnaire Score at Post-Intervention

  14-item questionnaire assessing acceptability of SASI. Items are ranked on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score is the average item score and ranges from 1-5. Higher total scores indicate greater overall acceptability.

  Week 15

• Recruitment Rate

  The percentage of screened participants who were enrolled in the study.

  Baseline

• Retention Rate

  Percentage of Enrolled Participants who completed the 15-Week intervention.

  Up to Week 15

• Protocol Adherence Rate

  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.

  Week 15

Secondary Outcomes (6)

• Change in Sleep Duration

  Baseline, Week 15

• Change in SAFTEE Questionnaire Scores

  Baseline, Week 15

• Change in Physical Activity

  Baseline, Week 15

• Change in Index of Self-Regulation (Sleep) Score

  Baseline, Week 15

• Change in PROMIS Fatigue 6a Morning Score

  Baseline, Week 15

Study Arms (1)

Short Sleep Patients

EXPERIMENTAL

Intervention: Self-management for Adequate Sleep Intervention (SASI). SASI was developed Dr. Michael Grandner. SASI is based on Cognitive Behavioral Therapy for Insomnia (CBTI), an established and effective approach for treating insomnia. Like CBTI, SASI extends sleep duration based on sleep efficiency (the proportion of time spent sleeping during a sleep episode). Bed times and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains \>90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules.

Behavioral: Sleep Intervention; Behavioral: Week 2 Intervention

Interventions

Sleep Intervention BEHAVIORAL

* Sleep Diaries (Daily) * Fitbit 24/7 * Phone/ video conference calls (weekly with study team) * Epworth Sleepiness Scale (weekly) * PROMIS fatigue scale-evening (weekly)

Short Sleep Patients

Week 2 Intervention BEHAVIORAL

* 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)

Short Sleep Patients

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University

New York, New York, 10010, United States

Location

Related Publications (3)

• Malone SK, Patterson F, Grunin L, Goyal C, Hu J, Perez NB, Munroe K, Dickson VV, Melkus GD. Single-arm pilot study of racial differences in sleep extension intervention outcomes among middle-aged adults at risk for metabolic syndrome. J Behav Med. 2026 Jan 13. doi: 10.1007/s10865-025-00624-4. Online ahead of print.

  PMID: 41528656 DERIVED

• Malone SK, Patterson F, Hu J, Goyal C, Goel N, Vaughan Dickson V, D'Eramo Melkus G, Aouizerat B. Association between dim light melatonin onset predicted from gene expression profiles with sleep time and chronotype preference: A pilot study. Chronobiol Int. 2025 Oct;42(10):1350-1359. doi: 10.1080/07420528.2025.2546006. Epub 2025 Aug 22.

  PMID: 40844144 DERIVED

• 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.

  PMID: 35067645 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Hypertension; Diabetes Mellitus, Type 2; Obesity, Abdominal; Dyslipidemias

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders

Results Point of Contact

• Title: Susan Malone, PhD, RN
• Organization: NYU Langone Health

Susan.Malone@nyulangone.org

212 992-7047

Study Officials

• Susan Malone, MD

  New York Langone Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 24, 2018
• Study Start: April 10, 2019
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: November 19, 2024
• Results First Posted: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available after all publications and presentations of the aims for this study are completed.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

Locations

US (1)