Sleep During Weight Loss and Weight Loss Maintenance
Conditions: Sleep, Weight Loss
Sponsor: Dartmouth-Hitchcock Medical Center

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Dartmouth College • Dartmouth-Hitchcock Medical Center 
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS 
CPHS.Tasks@Dartmouth.edu • 603-646-6482 
 
SOCIAL, BEHAVIORAL, and NON-CLINICAL RESEARCH PLAN 
CPHS template v. 04172017 
 
Please complete: CPHS# 31110          PI: Jessica K. Salwen-Deremer, PhD and Wai Sze Chan, PhD 
 
 
Important Note:  The CPHS Department (Chair & Scientific) Review Form is required with this 
application.  Find the form in the RAPPORT Library or on the CPHS Website.  
 
• Respond to each item, even if to indicate N/A or not applicable 
• Attach and/or upload this form as your ‘Investigator Protocol’ in Rapport 
• If you are completing this form on a Mac, indicate your answer to any checkboxes by bolding or 
highlighting, or by deleting any incorrect options. 
 
 
 
1. Introduction and Background 
 
Poor sleep is a risk factor of obesity. Meta-analyses have shown that short sleep duration is associated with 
higher body mass index (BMI) (Cappuccio et al. 2008; Chen, Beydoun, and Wang 2008). Experimentally 
induced sleep deprivation was found to be associated with greater caloric consumption (Brondel et al. 2010; 
Spaeth, Dinges, and Goel 2013). Sleep problems, late bedtime and high sleep duration variability were also 
found to be associated with higher BMI and obesogenic factors (Golley et al. 2013; Kjeldsen et al. 2014; 
Chan 2017; Baron et al. 2011) . Recent evidence suggests that good subjective sleep quality and morning 
chronotypes are associated with greater success in weight loss maintenance (Ross, Graham Thomas, and 
Wing 2016). Although evidence for the role of sleep in weight control is promising, prior findings were 
primarily cross-sectional or based on subjective reports of sleep. Moreover, few studies have examined 
changes of sleep during weight loss and weight loss maintenance. 
 
 
 
2. Objectives and Hypotheses 
 
The objectives of this study are to a) characterize subjective and objective sleep parameters in adults with 
obesity during weight loss and weight loss maintenance, b) examine the cross-sectional associations 
between sleep parameters and BMI in overweight and obese adults, and c) evaluate whether sleep 
parameters prospectively predict changes in BMI during weight loss and weight loss maintenance. We will 
also obtain data on a number of covariates and secondary outcomes including sleep disturbances, insomnia 
symptoms, risk of sleep apnea, circadian preferences, weight loss self-efficacy, emotional eating, mood and 
anxiety, executive functioning, loneliness and social isolation, and patients’ beliefs about how sleep might 
impact their weight control or vice versa. Findings from this study will shed light on the impact of sleep on 
weight loss and weight loss maintenance and the potential therapeutic role of sleep in improving weight 
control. 
 
 
 
3. Study Design 
 
Describe all study procedures, materials, and methods of data collection: 
 
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. 

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Participants will be consented to the study by a research staff in the PI’s office in Heater Road prior to the 
1st session. After informed consent is obtained, the patient will be asked to complete several questionnaires 
about sleep and wellbeing, which will take about 30 mins. The questionnaires will be administered using 
REDCap displayed on a tablet. Their height and weight will also be measured by the research staff. The 
patient will then be given a wrist-worn accelerometer (see description below) 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. Also, the research staff will collect food consumption 
data continuously. Each patient in HLP is expected to track their food consumption daily. This daily data 
will be collected by the research staff. Data on existing diagnosis of sleep disorders will be extracted from 
the patients’ electronic medical records. PHI request approval will be obtained prior to data extraction.  
 
Measures:  
The ActiGraph model wGT3X-BT will be used as a wrist-accelerometer to measure sleep and physical 
activity. The patient will be asked to wear this on the non-dominant hand throughout the day and during 
sleep except during showers or in situations where the accelerometer can be damaged. The model wGT3X-
BT does not have an interface and does not provide feedback to patients. Data will be downloaded either 
remotely if the patient has a smartphone to install the ActiGraph mobile app for remote data retrieval or in-
person when they attend their program visits. For in-person data download, the patient will return the 
accelerometer they used and be given another one at their program visit to minimize any waiting time 
needed for completing data retrieval.   
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.  
The Insomnia Severity Index (ISI) will be used to assess the severity of insomnia symptoms and 
subjective daytime impairments. 
The STOP-BANG Questionnaire will be used to assess the patient’s risk for sleep apnea. 
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.  
The Weight Loss Self-Efficacy Scale will be used to assess self-efficacy in one’s ability to lose or maintain 
weight.  
The Weight Control Strategies Scale will be used to assess strategies used to lose weight. 
Questions about beliefs related to sleep and weight control 
The Three Factors Eating Questionnaire will be used to measure emotional and disinhibited eating. 
Mood and Anxiety symptoms will be assessed using the PHQ9 and GAD7. 
Executive functioning will be assessed using the computerized delay discounting task and the response 
disinhibition task. 
Loneliness and social isolation will be assessed using the PROMIS isolation scale.  
Physical Activity Acceptance & Action Questionnaire (PA-AAQ) will be used to measure acceptance of 
physical and psychological discomfort in the context of physical activity. 
Food Craving Acceptance and Action Questionnaire (F-AAQ) will be used to measure acceptance of 
food related cravings and urges.  
 
 
 
4. Analysis 
 
Describe any qualitative tests and measures as well as quantitative methods: 
 
Mixed modeling will be used to model changes of weight and sleep during the 16 weeks of data collection 
and examine the associations between the changes of weight and sleep during weight loss and weight loss 
maintenance. 
 
 
5. Study Progress Monitoring 
 
Note:  appropriate monitoring may include periodic assessment of the following: 

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• data quality 
• timelines 
• recruitment and enrollment  
 
Provide a description of the methods which will be used to determine the progress of the study, 
including periodic assessments of data quality, timelines, recruitment, and enrollment as appropriate: 
 
The principal investigator will meet with the research coordinator weekly to monitor recruitment, 
enrollment and data collection. The PI will conduct monthly assessment of data quality to ensure that the 
data collection The PI will meet with the Co-Is once every three months or as needed to discuss progress 
and any problems in recruitment and data collection.  
 
 
 
6. Risks & Benefits 
 
Note: Risks may be physical, psychological, social, legal, economic, to reputation, or others.  
 
 
a. Describe any potential risks, their likelihood and seriousness: 
 
To the best of our knowledge, this study will have very minimal risks to the participants. Some 
participants may find the wrist-worn actigraph uncomfortable or causing allergic skin reactions. 
These reactions are usually temporary and occur in a small proportion of the participants. 
 
 
b. Confirm that risks to subjects have been minimized, by use of procedures which are consistent 
with sound research design and which do not unnecessarily expose subjects to risk: 
 
If an allergic reaction occurs, we will obtain other wrist-bands that will not cause an allergic 
reaction. The participants will also be reminded that they could withdraw from the study at any point 
if they find the data collection process is causing undesirable effects. 
 
 
 
c. Describe why all the risks to subjects are reasonable in relation to both anticipated benefits 
and the knowledge expected to be gained from the study: 
 
The knowledge gained from this study will provide some insight into how sleep could be a potential 
therapeutic target in weight loss and weight loss maintenance. Given that the risks to participants are 
very minimal and cause no lasting harm, we believe that the anticipated benefits will overweigh the 
risks. 
 
 
 
7. Unexpected Events or Incidental Findings 
 
Note: It may be important to consider the potential for certain unanticipated events to occur, for example: 
• finding an anomaly in a MRI 
• discovering child abuse 
• causing distress in interviews of a sensitive nature 
 
Describe potential events and provide a plan of action: 
 
With the sleep data collected, we may discover that a participant might likely have a sleep disorder. We will 
let the participant’s PCP know and recommend making a referral to the Sleep Medicine Center.   
 
 
 
 

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8. Deception 
 
Does any part of this study involve deception or withholding of information from participants? 
 
☐  Yes 
 
☒  No 
 
If Yes, provide an explanation which addresses the following: 
• A description of the deception being used 
• Why the deception is necessary 
• A plan for debriefing, or providing subjects with the pertinent information after participation 
 
N/A 
 
 
9. Equitable Participant Selection 
 
a. Estimated number of participants at Dartmouth CPHS reviewed sites:  
 
100 
 
b. Provide a justification of the proposed sample size 
The proposed N will allow adequate statistical power for detecting significant associations between 
sleep and weight.  
 
c. Define the target population: 
 
Adult overweight or obese patients who are enrolled in or who completed the Healthy Lifestyle 
Program at Weight and Wellness Center. 
 
 
d. Vulnerable populations 
 
Note: Certain populations are considered vulnerable to coercion and undue influence and are 
provided with additional protections when participating in a research study.   
 
Identify any of the below populations which you plan to recruit for this study.  In addition, 
complete the form(s) linked with each population as necessary and upload on the ‘Supporting 
Documents’ page in Rapport.  
☐ Pregnant Women, Fetuses and Neonates 
☐ Children 
☐ People with impaired decision-making capacity 
 
The following populations may also be considered vulnerable to coercion or other undue 
influence: 
• Prisoners 
• People who are economically disadvantaged  
• The elderly  
• People who are illiterate or do not speak English 
• Students and employees 
 
Describe any other potentially vulnerable population(s) and the additional protections 
provided to them: 
 
N/A 
 
 
 

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10. Recruitment 
 
Describe method(s) of recruitment.  Associated advertisements and other materials to be used for 
recruitment should be uploaded to the ‘Consent Forms and Recruitment Materials’ page in Rapport. 
 
Patients who are about to begin or complete the Healthy Lifestyle Program (HLP) at Weight and Wellness 
Clinic (WWC) will be given a pamphlet about this study. Interested patients will be invited to contact our 
research staff and be scheduled for a research visit. Recruitment materials will include a flyer and a facebook 
page (see attached). 
 
 
11. Informed Consent, Assent, and Authorization 
 
All forms discussed in this section should be uploaded to the ‘Consent Forms and Recruitment 
Materials’ page in Rapport 
 
a. Please describe the consent and/or assent process, addressing the following: 
• Who will obtain consent/assent from participants 
• Where the consent/assent process will take place 
• The timeframe for providing information potential participants about a study, having the consent 
form signed, and beginning study activities 
• Any precautions taken to minimize the possibility of coercion or undue influence 
• The forms which will be used as well as any aids used to simplify scientific or technical 
information 
• How comprehension will be ensured 
 
The PI and the research coordinator will obtain consent from participants. The consent process will 
take place in PI’s office. The PI/research coordinator will explain the study to the patients and ask if 
they have any questions or need to discuss with their providers or family before making the decision 
to participate in the study or not. They will be given as much time as they need to decide before the 
1st session of HLP or the last session of HLP. They will be given as much as one week to decide. To 
minimize the possibility of coercion or undue influence, the PI/research coordinator will emphasize 
that participation or not will not affect the care they receive. Based on the research team’s 
experience, interested patients might be more inclined to fill out a survey and have the research team 
contact them than initiating contact with the research team. Hence, we will create a facebook page 
containing the information about the study (same information as in the flyer) and a link to a REDCap 
survey where interested patients will be asked to complete a few eligibility questions and enter their 
contact information (see attachment).  
 
b. Waiver(s) or alteration(s) may be requested for research that involves no more than minimal 
risk.   
Indicate requested waiver(s) or alteration(s) below.  In addition, complete the corresponding 
section of the Waivers and Alterations Request Form and upload it to the ‘Consent Forms and 
Recruitment Materials’ page in Rapport.      
☐  For the informed consent process 
☐ For the documentation of informed consent 
☐ For the HIPAA Authorization to use and/or disclose PHI 
☐  For a waiver of the requirement for medical record documentation 
 
 
12. Compensation or Gifts 
 
Please describe any payments, gifts or reimbursements participants will receive for taking part in the 
study: 
 

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Each participant will receive up to 60 dollars in gas cards for taking part in the study. They will receive a 
gas card with a $20 value for completing the initial assessments in the 1st week. Then they will receive a gas 
card with a $20 value at the research visit at 8th week for completing the assessments again, and another gas 
card with a $20 value for completing the same assessments again at 16th week.  
 
 
13. Privacy of Participants  
 
Note: Methods used to obtain information about participants may have an effect on privacy.  For example: 
• Consent discussions or interviews held in public which concern sensitive subjects or behaviors 
• Observations of behavior, especially illicit behavior, in quasi-public settings 
 
Describe any activities or interactions which could lead to a breach of privacy and provide a plan to 
protect participant privacy: 
 
Consent discussions and measurements of height and weight will all be conducted in the PI’s office. 
 
 
 
 
14. Confidentiality of Data 
 
Note: Any person engaged in research collecting information that could cause financial, social or legal harm 
to participants may apply for a Certificate of Confidentiality.  Certificates of Confidentiality are issued by 
the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. 
They are intended to allow the investigator and others who have access to research records to refuse to 
disclose identifying information on research participants in any civil, criminal, administrative, legislative, or 
other proceeding, whether at the federal, state, or local level.  
 
a. If disclosed, could any of the data collected be considered sensitive, with the potential to 
damage financial standing, employability, insurability, or reputation? 
 
☒  No 
 
☐  Yes 
 
If Yes, describe the data or information, the rationale for their collection, and whether a 
Certificate of Confidentiality will be obtained: 
 
N/A 
 
b. Describe the safeguards employed to secure, share, and maintain data during the study, 
addressing any of the following which may apply:  
• Administrative, ie. coding of participant data  
• Physical, ie. use of locked file cabinets 
• Technical, ie. encrypted data systems 
 
Each participant will be assigned a research ID. All assessments will be labeled with the research ID. 
The only link between the research ID and identifying information will be the written consent form. 
The consent forms will be stored separately from the assessments. All materials will be stored in 
locked cabinets in the PI’s clinic and kept confidential. De-identified data that are stored 
electronically will be stored in encrypted data systems (REDCap, Dartmouth Webshare, and DH-
drive). 
 
c. Describe the plan for storage or destruction of data upon study completion: 
 
All of the research data not included in the medical record will be stored for 6 years following the 
completion of the study. Three years after the completion of the study analysis, the identifying data 

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will be destroyed. The de-identified database will be stored indefinitely for any future scientific 
investigation. 
 
 
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Partial Sleep Deprivation Increases Food Intake in Healthy Men.” American Journal of Clinical Nutrition 
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Cappuccio, Francesco, Frances Taggart, Ngianga-Bakwin Kandala, Andrew Currie, Ed Peile, Saverio Stranges, 
and Michelle Miller. 2008. “Meta-Analysis of Short Sleep Duration and Obesity in Children and Adults.” 
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