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Adding Sleep Intervention to Traditional Diet and Exercise Approach to Weight Loss

Primary Purpose

Sleep Initiation and Maintenance Disorders, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet and exercise
Cognitive Behavioral Therapy
Passion and Balance
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep Initiation and Maintenance Disorders focused on measuring Insomnia, Weight loss, Adults

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Gender: Both women and men
  • Age: > or = 18 years
  • Ethnicity and race: All ethnic and racial backgrounds welcome

  • The following, which will be measured at the screening clinic visit:

    • Body Mass Index: 28-40 (kg/m-squared)
    • Chronic Short Sleep: total sleep time < 6.5 hours, greater than or equal to 4 days per week (determined by 1-week sleep log) for the past 6 months or longer (based on self-report).
    • Insomnia: sleep latency and/or wake after sleep onset > 30 minutes, greater than or equal to 4 days per week, insomnia severity index > 10, and complaint of at least one negative effect during waking hours (such as fatigue, sleepiness, impaired functioning, mood disturbance) attributed to sleep (as determined by self report).
    • Eligible sleep disorder: sleep apnea or upper airway resistance syndrome treated by positive airway therapy for > or = 3 months resulting in improved sleep.
    • Psychiatric disorders that are stable on SSRI, SNRI, or bupropion antidepressant for greater than or equal to 3 months if no anticipated changes in medications to occur during the trial if they are weight stable.
    • Planning to be available for clinic visits and for the 8 weeks of study participation
    • Ability and willingness to give written informed consent.

Exclusion Criteria:At screening:

  • Sleep apnea (apnea-hypopnea index > 15/hr) determined by portable sleep diagnostic system Periodic limb movements during sleep (PLM with arousal index > 15/hr) determined by polysomnography.
  • Any suspected sleep disorders identified by the Global Sleep Assessment Questionnaire, including circadian rhythm disorders (including shift work), parasomnias, narcolepsy, and restless leg.
  • Self reported personal history of:
  • DSM-IV Axis-I and Axis-II diagnoses (i.e. eating disorders, bi-polar disorder, schizophrenia and other psychotic disorders, substance-related disorders, personality disorders, poorly controlled major depression and anxiety disorders determined by SCID) except those allowed under Inclusions.

  • Subjects currently receiving the following medications known to affect sleep(self report):

    • sedative hypnotics
    • sedative antidepressants
    • systemic steroids
    • anticonvulsants
    • histamine-1
    • receptor antagonists
    • narcotic analgesics
    • CNS stimulants
  • Body Mass Index (BMI) greater than 40.
  • Pregnant, Lactating, or <6 months post-partum.
  • Inability to communicate effectively with study personnel.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Diet & Exercise plus Sleep Intervention

Diet & Exercise plus Passion and Balance

Arm Description

Diet and exercise instruction to promote weight loss plus cognitive behavioral therapy for insomnia.

Diet and exercise instruction to promote weight loss plus sessions that are of general interest, but unrelated to diet, exercise, or sleep.

Outcomes

Primary Outcome Measures

Change from baseline in weight at 8 months
Change was calculated as the value at 8 months minus the value at baseline.

Secondary Outcome Measures

Change from baseline in scores of Insomnia Severity Index
Change was calculated as the value at 8 months minus the value at baseline.
Change from baseline in scores of Insomnia Frequency Questionnaire
Change was calculated as the value at 8 months minus the value at baseline.
Change from baseline in scores of Pittsburgh Sleep Quality Index
Change was calculated as the value at 8 months minus the value at baseline.
Change from baseline in scores of Monk Social Rhythm Questionnaire
Change was calculated as the value at 8 months minus the value at baseline.

Full Information

First Posted
June 1, 2010
Last Updated
February 18, 2023
Sponsor
Stanford University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01135342
Brief Title
Adding Sleep Intervention to Traditional Diet and Exercise Approach to Weight Loss
Official Title
Adding Sleep Intervention to Traditional Diet and Exercise Approach to Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal is to determine if improved sleep will increase/enhance weight loss among overweight adults with insomnia.
Detailed Description
The major purpose of this study is to examine the effect of sleep quality and quantity on weight loss. The outcomes being studied are weight loss and improved sleep. The subjects being studied are those with body mass index 28-40kg/m2 who report sleeping less than 6.5 hours per day for 4 day per week or more for the past 6 months or longer and would likely benefit the most from the sleep intervention should it prove to be effective. We hope to learn if improved sleep habits among overweight adults with insomnia will help them to adhere to a diet and exercise program and increase their success with weight loss. Given the current world-wide obesity epidemic and the established difficulties many people have with weight control, any approaches that can be demonstrated to contribute to successful weight loss have direct public health significance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders, Obesity
Keywords
Insomnia, Weight loss, Adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet & Exercise plus Sleep Intervention
Arm Type
Experimental
Arm Description
Diet and exercise instruction to promote weight loss plus cognitive behavioral therapy for insomnia.
Arm Title
Diet & Exercise plus Passion and Balance
Arm Type
Sham Comparator
Arm Description
Diet and exercise instruction to promote weight loss plus sessions that are of general interest, but unrelated to diet, exercise, or sleep.
Intervention Type
Behavioral
Intervention Name(s)
Diet and exercise
Intervention Description
Standardized instruction to eat less and exercise more to create an energy balance deficit to promote weight loss (16 classes)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Standardized cognitive behavioral therapy for insomnia (8 classes)
Intervention Type
Behavioral
Intervention Name(s)
Passion and Balance
Intervention Description
Attention-match sessions of general interest, but unrelated to diet, exercise, or sleep (8 sessions)
Primary Outcome Measure Information:
Title
Change from baseline in weight at 8 months
Description
Change was calculated as the value at 8 months minus the value at baseline.
Time Frame
Baseline and 8 months
Secondary Outcome Measure Information:
Title
Change from baseline in scores of Insomnia Severity Index
Description
Change was calculated as the value at 8 months minus the value at baseline.
Time Frame
Baseline and 8 months
Title
Change from baseline in scores of Insomnia Frequency Questionnaire
Description
Change was calculated as the value at 8 months minus the value at baseline.
Time Frame
Baseline and 8 months
Title
Change from baseline in scores of Pittsburgh Sleep Quality Index
Description
Change was calculated as the value at 8 months minus the value at baseline.
Time Frame
Baseline and 8 months
Title
Change from baseline in scores of Monk Social Rhythm Questionnaire
Description
Change was calculated as the value at 8 months minus the value at baseline.
Time Frame
Baseline and 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Gender: Both women and men Age: > or = 18 years Ethnicity and race: All ethnic and racial backgrounds welcome The following, which will be measured at the screening clinic visit: Body Mass Index: 28-40 (kg/m-squared) Chronic Short Sleep: total sleep time < 6.5 hours, greater than or equal to 4 days per week (determined by 1-week sleep log) for the past 6 months or longer (based on self-report). Insomnia: sleep latency and/or wake after sleep onset > 30 minutes, greater than or equal to 4 days per week, insomnia severity index > 10, and complaint of at least one negative effect during waking hours (such as fatigue, sleepiness, impaired functioning, mood disturbance) attributed to sleep (as determined by self report). Eligible sleep disorder: sleep apnea or upper airway resistance syndrome treated by positive airway therapy for > or = 3 months resulting in improved sleep. Psychiatric disorders that are stable on SSRI, SNRI, or bupropion antidepressant for greater than or equal to 3 months if no anticipated changes in medications to occur during the trial if they are weight stable. Planning to be available for clinic visits and for the 8 weeks of study participation Ability and willingness to give written informed consent. Exclusion Criteria:At screening: Sleep apnea (apnea-hypopnea index > 15/hr) determined by portable sleep diagnostic system Periodic limb movements during sleep (PLM with arousal index > 15/hr) determined by polysomnography. Any suspected sleep disorders identified by the Global Sleep Assessment Questionnaire, including circadian rhythm disorders (including shift work), parasomnias, narcolepsy, and restless leg. Self reported personal history of: DSM-IV Axis-I and Axis-II diagnoses (i.e. eating disorders, bi-polar disorder, schizophrenia and other psychotic disorders, substance-related disorders, personality disorders, poorly controlled major depression and anxiety disorders determined by SCID) except those allowed under Inclusions. Subjects currently receiving the following medications known to affect sleep(self report): sedative hypnotics sedative antidepressants systemic steroids anticonvulsants histamine-1 receptor antagonists narcotic analgesics CNS stimulants Body Mass Index (BMI) greater than 40. Pregnant, Lactating, or <6 months post-partum. Inability to communicate effectively with study personnel.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D Gardner
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://med.stanford.edu/nutrition/research/completed-studies/sleep-and-weight-loss.html
Description
Study description and summary of results.

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Adding Sleep Intervention to Traditional Diet and Exercise Approach to Weight Loss

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