Sleep During Weight Loss and Weight Loss Maintenance
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|ClinicalTrials.gov Identifier: NCT03774563|
Recruitment Status : Completed
First Posted : December 13, 2018
Last Update Posted : May 14, 2020
|Condition or disease|
|Sleep Weight Loss|
|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|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|
- 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.
- 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.
- 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.
- 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.
- 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.
- 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".
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|United States, New Hampshire|
|Dartmouth Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03766|
|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|