Short Term Effects of Increasing Sleep Duration

NCT ID: NCT01428687

Last Updated: 2016-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-08-31

Brief Summary

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A series of studies are proposed to develop an intervention to increase sleep duration and study the effects on eating, exercise, and weight control. The hypothesis is that increasing sleep duration will help improve weight loss and maintenance.

Detailed Description

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Study 1 is conducted in a sleep laboratory. Participants sleep short duration (approximately four hours per night) on one weekend and long duration (approximately nine hours per night) on another weekend.

Study 2 is examining ways to increase sleep duration in overweight individuals with short sleep and examining the effects on short term weight loss.

Study 3 is comparing a standard weight loss program with a novel Sleep+Weight Loss intervention.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Increase Sleep Gradually

Subjects in this condition are taught to increase their sleep by 30 minutes per night during week 1 of the intervention; 60 minutes during week 2; and 90 minutes during week 3. Following the sleep intervention, these participants receive a standard behavioral with loss intervention.

Group Type ACTIVE_COMPARATOR

Sleep Duration

Intervention Type BEHAVIORAL

Subjects are taught sleep hygiene strategies to increase their sleep; they record their sleep in a diary and wear an actigraph and call in their sleep to the office each day.

Increase Sleep Immediately

Subjects in this condition are taught to increase their sleep by 90 minutes per night starting in week 1. Following the sleep intervention, these participants receive a standard behavioral with loss intervention.

Group Type ACTIVE_COMPARATOR

Sleep Duration

Intervention Type BEHAVIORAL

Subjects are taught sleep hygiene strategies to increase their sleep; they record their sleep in a diary and wear an actigraph and call in their sleep to the office each day.

No Intervention: Control Group

This group is told to make no changes in their sleep habits. Following the sleep intervention, these participants receive a standard behavioral with loss intervention.

Group Type ACTIVE_COMPARATOR

No change in sleep

Intervention Type BEHAVIORAL

This group is taught to maintain their current sleep habits.

Interventions

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Sleep Duration

Subjects are taught sleep hygiene strategies to increase their sleep; they record their sleep in a diary and wear an actigraph and call in their sleep to the office each day.

Intervention Type BEHAVIORAL

No change in sleep

This group is taught to maintain their current sleep habits.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age 25 to 45;
* BMI 25 to 50;
* healthy;
* sleep 6.5 hours or less per night

Exclusion Criteria

* use of sleep medications;
* sleep apnea;
* third shift worker
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rena R. Wing

Professor of Psychiatry and Human Behavior

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rena R. Wing, PhD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Locations

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Weight Control & Diabetes Research Center

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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U01CA150387

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U01CA150387 - Study 2

Identifier Type: -

Identifier Source: org_study_id

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