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| ID | Type | Description | Link |
|---|---|---|---|
| 2T32DK063688-16 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The primary objective is to determine the cross-sectional relationship between sleep duration (as measured by 14 days of actigraphy) and glycemic control in an adolescent Type 2 Diabetes (T2DM) cohort (age 12-20y, n=67). A secondary objective is to determine if a loss-framed incentive for achieving sleep goals can increase sleep duration in 15 adolescent patients diagnosed with T2DM with insufficient sleep. Another secondary objective is to test if increasing sleep duration leads to improved glycemic control in 15 adolescents with T2DM identified in Aim 1 as having <8 hr sleep/evening. A focus group will be conducted prior to this intervention with patients ineligible for the intervention in order to determine appropriate text messaging.
Aim 1 will be a cross-sectional study design utilizing actigraphy watch devices to estimate sleep duration. Participants will be recruited either before or after a routine outpatient clinic visit and asked to complete intake questionnaires. They will then be provided an actigraphy watch device which will be worn for 14 days to estimate sleep duration, and Libre continuous glucose monitor (CGM) to estimate glycemic control. After their visit, clinical data will be extracted from the electronic medical record.
Aim 2 will be an interventional study design utilizing Fitbit to perform a loss-framed incentive intervention designed to motivate participants to increase their sleep duration. Glycemic control will be measured via laboratory testing of hemoglobin A1c and Libre continuous glucose monitoring (CGM) for 2 weeks pre- and post-intervention.
A focus group will be conducted prior to this intervention with patients ineligible for the intervention in order to determine appropriate text messaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | This will be a single-arm study utilizing a loss-framed incentive intervention to induce increased sleep duration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loss frame sleep extension intervention | Behavioral | Aim 2 will be an interventional study design utilizing Fitbit and text messaging to perform a loss-framed incentive intervention designed to motivate participants to increase their sleep duration. Glycemic control will be measured via laboratory testing of hemoglobin A1c and Libre continuous glucose monitoring (CGM) for 2 weeks pre- and post-intervention. A focus group will be conducted prior to this intervention with patients ineligible for the intervention in order to determine appropriate text messaging. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep duration (for Aim 2) | Will assess for sleep extension throughout intervention | 13 weeks |
| Hemoglobin A1c (for Aim 1) | Aim 1 is assessing cross-sectional relationship of A1c to sleep duration | baseline |
| BMI (for Aim 1) | Aim 1 is assessing cross-sectional relationship of BMI to sleep duration | baseline |
| Qualitative data from focus group | Qualitative output from focus group discussion on text messages | baseline at focus group |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control | Will assess for change in hemoglobin a1c throughout intervention | 13 weeks |
| Glycemic control | Will assess for change in continuous glucose monitor measures throughout intervention |
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Inclusion Criteria:
Aim 1 for child:
Aim 1 for parent:
1. Parent or legal guardian of child that meets inclusion criteria for Aim 1.
Aim 2 for child:
Focus group for child:
Exclusion Criteria:
Aim 1 for child:
Aim 1 for Parent:
Aim 2 for child:
1. Do not own a smart phone or tablet
Focus group for child:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Talia Hitt, MD/MPH | Contact | 215-590-3174 | hittt@chop.edu | |
| Beth Schwartzman | Contact | 215-590-3174 | schwartzmann@chop.edu |
| Name | Affiliation | Role |
|---|---|---|
| Talia A Hitt, MD/MPH | Children's Hospital of Philadelphia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28402773 | Background | Mayer-Davis EJ, Lawrence JM, Dabelea D, Divers J, Isom S, Dolan L, Imperatore G, Linder B, Marcovina S, Pettitt DJ, Pihoker C, Saydah S, Wagenknecht L; SEARCH for Diabetes in Youth Study. Incidence Trends of Type 1 and Type 2 Diabetes among Youths, 2002-2012. N Engl J Med. 2017 Apr 13;376(15):1419-1429. doi: 10.1056/NEJMoa1610187. | |
| 18517032 | Background | Cappuccio FP, Taggart FM, Kandala NB, Currie A, Peile E, Stranges S, Miller MA. Meta-analysis of short sleep duration and obesity in children and adults. Sleep. 2008 May;31(5):619-26. doi: 10.1093/sleep/31.5.619. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Aim 2 will be an interventional study design utilizing Fitbit to perform a loss-framed incentive intervention designed to motivate participants to increase their sleep duration with text message feedback. Glycemic control will be measured via laboratory testing of hemoglobin A1c and Libre continuous glucose monitoring (CGM) for 2 weeks pre- and post-intervention.
A focus group will be conducted prior to this intervention with patients ineligible for the intervention in order to determine appropriate text messaging.
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| 13 weeks |
| BMI | Will assess for change in body mass index (BMI) throughout intervention | 13 weeks |
| 27054407 | Background | Wheaton AG, Olsen EO, Miller GF, Croft JB. Sleep Duration and Injury-Related Risk Behaviors Among High School Students--United States, 2007-2013. MMWR Morb Mortal Wkly Rep. 2016 Apr 8;65(13):337-41. doi: 10.15585/mmwr.mm6513a1. |
| 20585000 | Background | Buxton OM, Pavlova M, Reid EW, Wang W, Simonson DC, Adler GK. Sleep restriction for 1 week reduces insulin sensitivity in healthy men. Diabetes. 2010 Sep;59(9):2126-33. doi: 10.2337/db09-0699. Epub 2010 Jun 28. |
| 16227462 | Background | Spiegel K, Knutson K, Leproult R, Tasali E, Van Cauter E. Sleep loss: a novel risk factor for insulin resistance and Type 2 diabetes. J Appl Physiol (1985). 2005 Nov;99(5):2008-19. doi: 10.1152/japplphysiol.00660.2005. |
| 21411507 | Background | Knutson KL, Van Cauter E, Zee P, Liu K, Lauderdale DS. Cross-sectional associations between measures of sleep and markers of glucose metabolism among subjects with and without diabetes: the Coronary Artery Risk Development in Young Adults (CARDIA) Sleep Study. Diabetes Care. 2011 May;34(5):1171-6. doi: 10.2337/dc10-1962. Epub 2011 Mar 16. |
| 26881417 | Background | Patel MS, Asch DA, Rosin R, Small DS, Bellamy SL, Heuer J, Sproat S, Hyson C, Haff N, Lee SM, Wesby L, Hoffer K, Shuttleworth D, Taylor DH, Hilbert V, Zhu J, Yang L, Wang X, Volpp KG. Framing Financial Incentives to Increase Physical Activity Among Overweight and Obese Adults: A Randomized, Controlled Trial. Ann Intern Med. 2016 Mar 15;164(6):385-94. doi: 10.7326/M15-1635. Epub 2016 Feb 16. |
| D004700 | Endocrine System Diseases |