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NCT Number: NCT01428687

Short Term Effects of Increasing Sleep Duration

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.

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Key information

Conditions

Overweight and Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Weight Control & Diabetes Research Center

Providence, Rhode Island, 02903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep duration

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 change in sleep

Behavioral

This group is taught to maintain their current sleep habits.

Primary outcomes

  1. Sleep Duration

    Time frame: 4 weeks

    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.

Secondary outcomes

  1. Eating Behavior

    Time frame: 4 weeks

    24-hour recalls are used to estimate dietary intake at baseline and after 4 weeks of sleep intervention.

  2. Physical Activity

    Time frame: 4 weeks

    Objective measures of physical activity are obtained before and after the 4-week sleep intervention.

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Registry information

Official study title

Increasing Sleep Duration: A Novel Approach to Weight Control

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Sep 5, 2011
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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