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Weight Outlooks by Restriction of Diet and Sleep (WORDS)

Primary Purpose

Weight

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Calorie restriction only

Sleep & calorie restriction

About this trial

This is an interventional other trial for Weight focused on measuring body composition, anthropometry

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

age between 35-55 years,
BMI between 30-35 kg/meters squared,
total sleep time between 6.5-8 hours

Exclusion Criteria:

work requiring changing schedule,
use of sleep aids or sleep medication

Sites / Locations

University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Calorie Restriction Only

Sleep & Calorie Restriction

Arm Description

Participants in this group will be decreasing their caloric intake to approximately 95% of their resting metabolic rate. We will provide one meal for 4 days of the week, and participants will be required to keep an accurate dietary record of all food and drink. Participants assigned to this group will be instructed to keep a fixed sleep schedule based on their own sleep/napping habits.

Participants in this group will decrease their caloric intake to approximately 95% of their resting metabolic rate in addition to reducing their total time in bed by 90 minutes 5 days a week.

Outcomes

Primary Outcome Measures

body composition measured via DXA scans

Body composition will be measured via DXA scans prior to intervention and post intervention to compare losses in lean body mass and fat mass.

Secondary Outcome Measures

Full Information

NCT ID

NCT02413866

First Posted

April 7, 2015

Last Updated

April 17, 2019

Sponsor

University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT02413866

Brief Title

Weight Outlooks by Restriction of Diet and Sleep

Acronym

WORDS

Official Title

Weight Outlooks by Restriction of Diet and Sleep

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of South Carolina

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to examine whether chronic moderate sleep restriction effects the amount of body fat and lean mass loss, and calorie expenditure, in individuals who are participating in a dietary weight loss program.

Detailed Description

Participants will be randomly assigned to an 8-week program of either restricted diet alone, or restricted diet with restricted sleep for 5 days a week. The total expected duration of participation is approximately 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Weight

Keywords

body composition, anthropometry

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Calorie Restriction Only

Arm Type

Experimental

Arm Description

Arm Title

Sleep & Calorie Restriction

Arm Type

Experimental

Arm Description

Participants in this group will decrease their caloric intake to approximately 95% of their resting metabolic rate in addition to reducing their total time in bed by 90 minutes 5 days a week.

Intervention Type

Behavioral

Intervention Name(s)

Calorie restriction only

Intervention Description

Participants randomly assigned to this group will be instructed to reduce their daily energy intake to 95% of their resting metabolic rate.

Intervention Type

Behavioral

Intervention Name(s)

Sleep & calorie restriction

Intervention Description

Participants randomly assigned to this group will be instructed to reduce their total time in bed by 90 minutes 5 days a week, in addition to restricting their dietary intake to approximately 95% of their resting metabolic rate.

Primary Outcome Measure Information:

Title

body composition measured via DXA scans

Description

Body composition will be measured via DXA scans prior to intervention and post intervention to compare losses in lean body mass and fat mass.

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age between 35-55 years, BMI between 30-35 kg/meters squared, total sleep time between 6.5-8 hours Exclusion Criteria: work requiring changing schedule, use of sleep aids or sleep medication

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xuewen Wang, PhD

Organizational Affiliation

University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of South Carolina

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29208

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33644759

Citation

Sparks JR, Porter RR, Youngstedt SD, Bowyer KP, Durstine JL, Wang X. Effects of moderate sleep restriction during 8-week calorie restriction on lipoprotein particles and glucose metabolism. Sleep Adv. 2021 Jan 28;1(1):zpab001. doi: 10.1093/sleepadvances/zpab001. eCollection 2020.

Results Reference

derived

PubMed Identifier

29438540

Citation

Wang X, Sparks JR, Bowyer KP, Youngstedt SD. Influence of sleep restriction on weight loss outcomes associated with caloric restriction. Sleep. 2018 May 1;41(5):10.1093/sleep/zsy027. doi: 10.1093/sleep/zsy027.

Results Reference

derived

Learn more about this trial

Weight Outlooks by Restriction of Diet and Sleep

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