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P20 Extending Sleep to Reverse Metabolic Syndrome

NCT03596983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-11-19

Study results available
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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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Susan Malone, MD · New York Langone Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2021-06-04
Completion
2021-06-04

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03596983 on ClinicalTrials.gov