NCT01428687

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

5 years

First QC Date

September 1, 2011

Last Update Submit

August 29, 2016

Conditions

Overweight and Obesity

Keywords

Weight lossSleep duration

Outcome Measures

Primary Outcomes (1)

  • Sleep Duration

    Participants with verified short sleep are taught to increase their sleep either gradually or immediately. These two groups are compared to a control group who makes no changes in their sleep. The primary outcome is sleep duration per night as determined by actigraphy.

    4 weeks

Secondary Outcomes (2)

  • Eating Behavior

    4 weeks

  • Physical Activity

    4 weeks

Study Arms (3)

Increase Sleep Gradually

ACTIVE COMPARATOR

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.

Behavioral: Sleep Duration

Increase Sleep Immediately

ACTIVE COMPARATOR

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.

Behavioral: Sleep Duration

No Intervention: Control Group

ACTIVE COMPARATOR

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.

Behavioral: No change in sleep

Interventions

Sleep DurationBEHAVIORAL

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 GraduallyIncrease Sleep Immediately
No change in sleepBEHAVIORAL

This group is taught to maintain their current sleep habits.

No Intervention: Control Group

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • use of sleep medications;
  • sleep apnea;
  • third shift worker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control & Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

OverweightObesityWeight Loss

Interventions

Sleep DurationSleep

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rena R. Wing, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Human Behavior

Study Record Dates

First Submitted

September 1, 2011

First Posted

September 5, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations

US(1)