Clinical trial NCT03774563: Sleep During Weight Loss and Weight Loss Maintenance
Official title: Sleep During Weight Loss and Weight Loss Maintenance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Weight Loss
Keywords: weight loss
sleep
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2018-12-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who are about to begin the Healthy Lifestyle Program at the Weight and Wellness Clinic.

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.

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.

Eligibility 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:

Primary outcomes:
measure: Change in sleep duration
timeFrame: Week 1 and 16th week
measure: Changes in physical activity
timeFrame: Week 1 and 16th week
measure: Change in sleep quality
timeFrame: Week 1, 8th week, and 16th week
measure: Change in Severity of Insomnia
timeFrame: Week 1, 8th week, and 16th week
measure: Change in Risk for sleep apnea
timeFrame: Week 1, 8th week, and 16th week
measure: Change in Peak alertness
timeFrame: Week 1, 8th week, and 16th week
measure: Change in self-efficacy in one's ability to lose or maintain weight
timeFrame: Week 1, 8th week, and 16th week
measure: Change in strategies to lose weight
timeFrame: Week 1, 8th week, and 16th week
measure: Change in emotional and disinhibited eating
timeFrame: Week 1, 8th week, and 16th week
measure: Mood symptoms
timeFrame: Week 1, 8th week, and 16th week
measure: Change in Delayed Discounting Index
timeFrame: Week 1, 8th week, and 16th week
measure: Change in social isolation
timeFrame: Week 1, 8th week, and 16th week
measure: Anxiety symptoms
timeFrame: Week 1, 8th week, and 16th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Wai S Chan, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth College
name: Sivan Rotenberg, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth-Hitchcock Medical Center
name: Jessica K Salwen-Deremer, Phd
role: PRINCIPAL_INVESTIGATOR
References: