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Sleep During Weight Loss and Weight Loss Maintenance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774563
Recruitment Status : Completed
First Posted : December 13, 2018
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Jessica.K.Salwen-Deremer, Dartmouth-Hitchcock Medical Center

Brief Summary:
The purpose of the study is to examine the changes of sleep during weight loss and weight loss management. The research staff will also obtain data on sleep disturbances, insomnia symptoms, risk of sleep apnea, circadian preferences, weight loss self-efficacy, emotional eating, executive functioning, loneliness and social isolation, and patients' beliefs about how sleep might impact their weight control or vice versa.

Condition or disease
Sleep Weight Loss

Detailed Description:
This study is an observational study using a longitudinal data collection design with non-invasive measures. Fifty participants who are about to begin the Healthy Lifestyle Program (HLP) at the Weight and Wellness Clinic (WWC) and another 50 participants who are about to complete HLP will be recruited to the study. After informed consent is obtained, the patient will be asked to complete several questionnaires about sleep and wellbeing. Their height and weight will also be measured by the research staff. The patient will then be given a wrist-worn accelerometer to wear for 16 weeks to measure their sleep and physical activity. They will be asked to complete the same set of questions at approximately the 8th and 16th week at a research visit. Data on existing diagnosis of sleep disorders will be extracted from the patients' electronic medical records.

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep During Weight Loss and Weight Loss Maintenance
Actual Study Start Date : January 28, 2019
Actual Primary Completion Date : November 5, 2019
Actual Study Completion Date : November 5, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in sleep duration [ Time Frame: Week 1 and 16th week ]
    Sleep parameters measured by the ActiGraph model wGT3X-BT, a wrist-accelerometer. Measured in minutes of sleep per night. Higher number indicating longer sleep duration. Change from week 1 to week 16 will be measured.

  2. Changes in physical activity [ Time Frame: Week 1 and 16th week ]
    Measured by the Actigraph model wGT3X-BT, a wrist accelerometer. Measured in minutes of moderate to vigorous activity.

  3. Change in sleep quality [ Time Frame: Week 1, 8th week, and 16th week ]
    Pittsburgh Sleep Quality Index (PSQI) will be used to assess a range of sleep disturbances including insomnia, sleep-related breathing difficulties, and use of sleep aids. A total score of 5 or more is indicative of poor sleep quality. Possible score range is 0-21.

  4. Change in Severity of Insomnia [ Time Frame: Week 1, 8th week, and 16th week ]
    Insomnia Severity Index (ISI) will be used to assess the severity of insomnia symptoms and subjective daytime impairments.The total score ranges from 0 to 63, with higher scores indicating more severe anxiety symptoms.

  5. Change in Risk for sleep apnea [ Time Frame: Week 1, 8th week, and 16th week ]
    The STOP-BANG Questionnaire will be used to assess the patient's risk for sleep apnea. Scores range from 0-8. The higher the score indicates an increase in the probability of sleep apnea.

  6. Change in Peak alertness [ Time Frame: Week 1, 8th week, and 16th week ]
    The Morningness-Eveningness Questionnaire (MEQ) will be used to assess whether the patient's circadian rhythm produces peak alertness in the morning or the evening. Multiple choice, 4-5 point scale. The sum gives a score ranging from 16 to 86; scores of 41 and below indicate "evening types", scores of 59 and above indicate "morning types", scores between 42-58 indicate "intermediate types".

  7. Change in self-efficacy in one's ability to lose or maintain weight [ Time Frame: Week 1, 8th week, and 16th week ]
    The Weight Loss Self-Efficacy Scale will be used to assess self-efficacy in one's ability to lose or maintain weight. Measured by subjective rating percentages of confidence, 0-100%. The higher the percentage the higher the ability to maintain or lose weight.

  8. Change in strategies to lose weight [ Time Frame: Week 1, 8th week, and 16th week ]
    The Weight Control Strategies Scale will be used to assess strategies used to lose weight. The sum of scores ranges from 0-120. The higher the scores the more strategies being used to lose weight.

  9. Change in emotional and disinhibited eating [ Time Frame: Week 1, 8th week, and 16th week ]
    Three Factors Eating Questionnaire will be used to measure emotional and disinhibited eating. Comprised of 18 items , which are aggregated to three separate scale scores. A 4-point response format is used.

  10. Mood symptoms [ Time Frame: Week 1, 8th week, and 16th week ]
    will be assessed using the Patient Healthy Questionnaire (PHQ9). The PHQ9 scores range from 0-27, with lower numbers indicating minimal to no depression and higher numbers indicating severe depression.

  11. Change in Delayed Discounting Index [ Time Frame: Week 1, 8th week, and 16th week ]
    Executive functioning will be assessed using the delay discounting task and the response disinhibition task. K index corresponding to the degree to which a participant discounts future rewards compared to immediate rewards. Will be computed based on a validated algorithm.

  12. Change in social isolation [ Time Frame: Week 1, 8th week, and 16th week ]
    Social isolation will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) isolation scale. The PROMIS scale has six items each with a response options ranging in value from one to five. The lowest possible score is 6 and highest possible score is 30.

  13. Anxiety symptoms [ Time Frame: Week 1, 8th week, and 16th week ]
    will be assessed using the Generalized Anxiety Disorder-7 (GAD7). The GAD7 scores range from 5-21, with 5-9 indicating mild, 10-14 moderate, and greater than 15 severe anxiety.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Individuals who are about to begin the Healthy Lifestyle Program at the Weight and Wellness Clinic.
Criteria

Inclusion Criteria:

  • Adult overweight or obese patients who are enrolled in or who completed the Healthy Lifestyle Program at Weight and Wellness Center.Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774563


Locations
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United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
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Principal Investigator: Wai S Chan, Phd Dartmouth College
Principal Investigator: Sivan Rotenberg, Phd Dartmouth College
Principal Investigator: Jessica K Salwen-Deremer, Phd Dartmouth-Hitchcock Medical Center
  Study Documents (Full-Text)

Documents provided by Jessica.K.Salwen-Deremer, Dartmouth-Hitchcock Medical Center:
Study Protocol  [PDF] November 14, 2018

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Responsible Party: Jessica.K.Salwen-Deremer, Clinical Psychologist, Phd, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03774563    
Other Study ID Numbers: D19005
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessica.K.Salwen-Deremer, Dartmouth-Hitchcock Medical Center:
weight loss
sleep
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Body Weight Changes