CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Sleep Intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03596983
NCT03596983N/ACompleted

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

NYU Langone Health·interventional·Posted Jul 24, 2018·Updated Nov 19, 2024

In Brief

A clinical study evaluating Sleep Intervention and Week 2 Intervention for Metabolic Syndrome. Completed, enrolled 44 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 24, 2018
Enrollment StartApr 10, 2019
Primary CompletionJun 4, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.9 years ago

Interventions

Sleep Interventionbehavioral

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

Week 2 Interventionbehavioral

* 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)