Sleep During Weight Loss and Weight Loss Maintenance

Sleep Clinical Trial

Official title:

Sleep During Weight Loss and Weight Loss Maintenance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03774563
• Other study ID #: D19005
• Status: Completed
• Start date: January 28, 2019
• Est. completion date: November 5, 2019

Study information

• Verified date: May 2020
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 5, 2019
• Est. primary completion date: November 5, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Body Weight
• Sleep
• Weight Loss

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sleep duration	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.	Week 1 and 16th week
Primary	Changes in physical activity	Measured by the Actigraph model wGT3X-BT, a wrist accelerometer. Measured in minutes of moderate to vigorous activity.	Week 1 and 16th week
Primary	Change in sleep quality	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.	Week 1, 8th week, and 16th week
Primary	Change in Severity of Insomnia	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.	Week 1, 8th week, and 16th week
Primary	Change in Risk for sleep apnea	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.	Week 1, 8th week, and 16th week
Primary	Change in Peak alertness	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".	Week 1, 8th week, and 16th week
Primary	Change in self-efficacy in one's ability to lose or maintain weight	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.	Week 1, 8th week, and 16th week
Primary	Change in strategies to lose weight	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.	Week 1, 8th week, and 16th week
Primary	Change in emotional and disinhibited eating	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.	Week 1, 8th week, and 16th week
Primary	Mood symptoms	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.	Week 1, 8th week, and 16th week
Primary	Change in Delayed Discounting Index	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.	Week 1, 8th week, and 16th week
Primary	Change in social isolation	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.	Week 1, 8th week, and 16th week
Primary	Anxiety symptoms	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.	Week 1, 8th week, and 16th week