Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
80 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-12-10
Study Completion Date
2025-12-10
Brief Summary
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The goal of this study is to compare the impact of a SMART ((specific, measurable, attainable, realistic, or timely) Goal setting protocol on body weight, metabolic parameters (Hemoglobin A1c, lipids), diet quality and physical activity frequency in obese children with prediabetes in the outpatient setting. The main question is if participants using the SMART Goal Setting Protocol (SGSP) will have a significant reduction. The participants randomized to the study group will receive the SGSP, consisting of the SMART Goal Selection Guide (SGSG) and Weekly Goal Monitoring Tool (WGMT), in BMI Z-score, A1c, and dyslipidemia in 6 months compared to controls.
Detailed Description
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Implementing a SMART goal-setting protocol for the overweight and obese pediatric population with prediabetes can benefit patients by empowering participants to set their own goals. In addition, utilizing a standardized tool can provide a more focused approach to behavior change between visits and increase a child's sense of self- efficacy and autonomy which may enhance motivation and engagement in the treatment process. This study can add strength to current interventions involving childhood obesity and prediabetes management and may inform the development of a more effective interventions in this population. By providing evidenced-based strategies, this study has the potential to improve the health of children at risk for type 2 diabetes.
The investigators will recruit 60 participants with newly diagnosed prediabetes to the proposed study.
Participants will be recruited from the outpatient clinic of the Children's Diabetes Center at the Cohen Children's Medical Center, Long Island, NY.
Participants will be randomized in a 1:1 ratio to one of the two arms. The participants will be stratified by Tanner stage (II and III vs IV and V) and sex (Male vs Female) before randomization.
The Medical Nutrition therapy (MNT) Protocol and visit frequency will be the same for all of the study participants in both the study and standard of care group in which the Registered Dietician (RD) will reinforce and encourage healthy habits and behaviors In addition successes and barriers to change.
At the end of each visit, the participants in the standard of care (SOC) group will be asked to provide a summary of topics discussed and what the participants plan to improve on from now and their next visit: responses will be documented in the EMR, and participants will schedule a follow-up visit in 1-4 months.
The participant randomized in the study group will first receive the SGSG which will highlight 3 domains of SMART goals (exercise, diet, and behavior). Each domain will have 1 predetermined and unchanging primary goal which will serve as the standard for all participants to strive for based on the latest literature recommendations. In addition, each domain will provide a list of examples of SMART goals for participants to choose from. Participants will be asked to independently select and personalize 2-3 SMART goals from this list.
The Registered Dietitian will identify the patient's perceived challenges in achieving their goal, work collaboratively with the patient to problem-solve and make necessary modifications to the goal to overcome challenges. The provider may suggest scaling back the goal if participant reports that perceived challenges are deemed to be significant or participants may choose to work on new goals or will intensify current goals as necessary at the end of each follow-up. The goal will be recorded in the WGMT for progress evaluation and monitoring. This tool should be returned at follow-up. The WGMT will be documented into the patients' chart and scanned into the Electronic Medical Record (EMR).
The study will evaluate changes in weight throughout the intervention by measuring participants anthropometric parameters, including height, weight, and BMI. These measurements will be taken at baseline, 1-4 months, and 4-7 months using the Touchbase Electronic medical record system, which will calculate BMI based on CDC growth charts adjusted for age and sex based.
To assess changes in metabolic parameters, routine laboratory data will be collected based on the discretion of the attending endocrinologist per the standard of care. This will include Hemoglobin A1c, lipid panel and blood pressure. The data will be used to evaluate changes in metabolic health over the course of the study.
The investigators will recruit 60 participants with newly diagnosed prediabetes to the proposed study.
Participants will be recruited from the outpatient clinic of the Children's Diabetes Center at the Cohen Children's Medical Center, Long Island, NY.
Participants will be randomized in a 1:1 ratio to one of the two arms. The participants will be stratified by Tanner stage (II and III vs IV and V) and sex (Male vs Female) before randomization.
The Medical Nutrition therapy (MNT) Protocol and visit frequency will be the same for all of the study participants in both the study and standard of care group in which the Registered Dietician (RD) will reinforce and encourage healthy habits and behaviors In addition successes and barriers to change.
At the end of each visit, the participants in the standard of care (SOC) group will be asked to provide a summary of topics discussed and what the participants plan to improve on from now and their next visit: responses will be documented in the EMR, and participants will schedule a follow-up visit in 1-4 months.
The participant randomized in the study group will first receive the SGSG which will highlight 3 domains of SMART goals (exercise, diet, and behavior). Each domain will have 1 predetermined and unchanging primary goal which will serve as the standard for all participants to strive for based on the latest literature recommendations. In addition, each domain will provide a list of examples of SMART goals for participants to choose from. Participants will be asked to independently select and personalize 2-3 SMART goals from this list.
The Registered Dietitian will identify the patient's perceived challenges in achieving their goal, work collaboratively with the patient to problem-solve and make necessary modifications to the goal to overcome challenges. The provider may suggest scaling back the goal if participant reports that perceived challenges are deemed to be significant or participants may choose to work on new goals or will intensify current goals as necessary at the end of each follow-up. The goal will be recorded in the WGMT for progress evaluation and monitoring. This tool should be returned at follow-up. The WGMT will be documented into the patients' chart and scanned into the Electronic Medical Record (EMR).
The study will evaluate changes in weight throughout the intervention by measuring participants anthropometric parameters, including height, weight, and BMI. These measurements will be taken at baseline, 1-4 months, and 4-7 months using the Touchbase Electronic medical record system, which will calculate BMI based on CDC growth charts adjusted for age and sex based.
To assess changes in metabolic parameters, routine laboratory data will be collected based on the discretion of the attending endocrinologist per the standard of care. This will include Hemoglobin A1c, lipid panel and blood pressure. The data will be used to evaluate changes in metabolic health over the course of the study.
Conditions
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PreDiabetes
Adolescent Obesity
Behavior, Health
Nutritional and Metabolic Diseases
Diet Habit
Lifestyle Risk Reduction
Keywords
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Nutrition
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
We'll enroll 60 pediatric subjects diagnosed with prediabetes within three months at the Pediatric Diabetes Clinic. These subjects will be randomly assigned to two arms. All participants will receive standardized medical nutrition therapy protocol and visit frequency from RD. Study group participants will get the SGSP, consisting of the SMART Goal Selection Guide (SGSG) and Weekly Goal Monitoring Tool (WGMT). SGSG will outline three SMART goal domains (exercise, diet, behavior) with a primary goal and example goals. Participants will personalize 2-3 SMART goals, those in standard of care group will just be asked "what changes they plan to make".
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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SMART GOAL Arm
The participants randomized to the study group will receive the SGSP, consisting of the SMART Goal Selection Guide (SGSG) and Weekly Goal Monitoring Tool (WGMT), which will be used in tandem.
The study group participants will also be asked to summarize the information discussed during the visit, and then will receive the SMART (Specific, Measurable, Attainable, Realistic, Time sensitive) Goal Setting Protocol (SGSP).
Group Type
EXPERIMENTAL
SMART GOALS Setting Tool/ Protocol
Intervention Type
BEHAVIORAL
The participants randomized to the study group will receive the SGSP, consisting of the SMART Goal Selection Guide (SGSG) and Weekly Goal Monitoring Tool (WGMT), which will be used in tandem. The participant will first receive the SGSG which will highlight 3 domains of SMART goals (exercise, diet, and behavior). Each domain will have 1 predetermined and unchanging primary goal which will serve as the standard for all participants to strive for.
Standard of Care Arm
Participants randomized to this group will receive standard of care.
At the end of each visit, the participants in the standard of care (SOC) group will be asked to provide a summary of topics discussed and what they plan to improve on from now and their next visit:
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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SMART GOALS Setting Tool/ Protocol
The participants randomized to the study group will receive the SGSP, consisting of the SMART Goal Selection Guide (SGSG) and Weekly Goal Monitoring Tool (WGMT), which will be used in tandem. The participant will first receive the SGSG which will highlight 3 domains of SMART goals (exercise, diet, and behavior). Each domain will have 1 predetermined and unchanging primary goal which will serve as the standard for all participants to strive for.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
1. Children between ages 10-18 years at baseline visit
2. Children with BMI for age and sex ≥ 85th percentile at baseline visit
3. Children with hemoglobin A1c 5.7% to 6.4% at baseline visit
2. Children with BMI for age and sex ≥ 85th percentile at baseline visit
3. Children with hemoglobin A1c 5.7% to 6.4% at baseline visit
Exclusion Criteria
1. Children who are not able to provide assent to the study
2. Children less than 10 years in age
3. Children that are not interested in weight loss or diet and lifestyle change
4. Children with known diabetes that use medications that alter glucose or lipid metabolism such as (insulin, metformin, Glucagon Like Peptide-1 Receptor Antagonist (GLP-1 RA), Statins, Accutane).
5. Children on medications that can alter body weight (including antidepressants, steroids, stimulants).
6. Children with documented learning and/or intellectual disabilities as identified through the electronic medical record (such as cognitive disability or autism spectrum disorder)
7. Children with known psychiatric disorders disabilities as identified through the electronic medical record (e.g., schizophrenia, depression, bipolar disorder, or psychosis
8. Children that have known medical conditions, including endocrine dysfunction, Cushing's Syndrome, or other systemic illness
9. Children with known or suspected eating disorders as identified through the electronic medical record
10. Children that have known genetic or syndromic obesity
11. Female children who are pregnant
2. Children less than 10 years in age
3. Children that are not interested in weight loss or diet and lifestyle change
4. Children with known diabetes that use medications that alter glucose or lipid metabolism such as (insulin, metformin, Glucagon Like Peptide-1 Receptor Antagonist (GLP-1 RA), Statins, Accutane).
5. Children on medications that can alter body weight (including antidepressants, steroids, stimulants).
6. Children with documented learning and/or intellectual disabilities as identified through the electronic medical record (such as cognitive disability or autism spectrum disorder)
7. Children with known psychiatric disorders disabilities as identified through the electronic medical record (e.g., schizophrenia, depression, bipolar disorder, or psychosis
8. Children that have known medical conditions, including endocrine dysfunction, Cushing's Syndrome, or other systemic illness
9. Children with known or suspected eating disorders as identified through the electronic medical record
10. Children that have known genetic or syndromic obesity
11. Female children who are pregnant
Minimum Eligible Age
10 Years
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Northwell Health
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Benjamin U. Nwosu, MD
Role: PRINCIPAL_INVESTIGATOR
NORTHWELL HEALTH, INC.
Locations
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Northwell Health
New York, New York, United States
Site Status
RECRUITING
Northwell Health
New York, New York, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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Rashida Talib, MPH
Role: primary
Nessa Wardak
Role: backup
Thomas Zachmann
Role: primary
References
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Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of Obesity and Severe Obesity Among Adults: United States, 2017-2018. NCHS Data Brief. 2020 Feb;(360):1-8.
Reference Type
BACKGROUND
Flechtner-Mors M, Thamm M, Wiegand S, Reinehr T, Schwab KO, Kiess W, Widhalm K, Holl RW; APV initiative and the BMBF Competence Network Obesity. Comorbidities related to BMI category in children and adolescents: German/Austrian/Swiss Obesity Register APV compared to the German KiGGS Study. Horm Res Paediatr. 2012;77(1):19-26. doi: 10.1159/000334147. Epub 2011 Nov 22.
Reference Type
BACKGROUND
Han JC, Lawlor DA, Kimm SY. Childhood obesity. Lancet. 2010 May 15;375(9727):1737-48. doi: 10.1016/S0140-6736(10)60171-7. Epub 2010 May 5.
Reference Type
BACKGROUND
Daniels SR. Complications of obesity in children and adolescents. Int J Obes (Lond). 2009 Apr;33 Suppl 1:S60-5. doi: 10.1038/ijo.2009.20.
Reference Type
BACKGROUND
Wing RR, Lang W, Wadden TA, Safford M, Knowler WC, Bertoni AG, Hill JO, Brancati FL, Peters A, Wagenknecht L; Look AHEAD Research Group. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care. 2011 Jul;34(7):1481-6. doi: 10.2337/dc10-2415. Epub 2011 May 18.
Reference Type
BACKGROUND
Weiss R, Taksali SE, Tamborlane WV, Burgert TS, Savoye M, Caprio S. Predictors of changes in glucose tolerance status in obese youth. Diabetes Care. 2005 Apr;28(4):902-9. doi: 10.2337/diacare.28.4.902.
Reference Type
BACKGROUND
Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.
Reference Type
BACKGROUND
Kelley CP, Sbrocco G, Sbrocco T. Behavioral Modification for the Management of Obesity. Prim Care. 2016 Mar;43(1):159-75, x. doi: 10.1016/j.pop.2015.10.004.
Reference Type
BACKGROUND
International Pediatric Endosurgery Group (IPEG). IPEG guidelines for surgical treatment of extremely obese adolescents. J Laparoendosc Adv Surg Tech A. 2009 Apr;19 Suppl 1:xiv-xvi. doi: 10.1089/lap.2009.9981.supp. No abstract available.
Reference Type
BACKGROUND
Armstrong SC, Bolling CF, Michalsky MP, Reichard KW; SECTION ON OBESITY, SECTION ON SURGERY. Pediatric Metabolic and Bariatric Surgery: Evidence, Barriers, and Best Practices. Pediatrics. 2019 Dec;144(6):e20193223. doi: 10.1542/peds.2019-3223. Epub 2019 Oct 27.
Reference Type
BACKGROUND
Ameer B, Weintraub MA. Pediatric Obesity: Influence on Drug Dosing and Therapeutics. J Clin Pharmacol. 2018 Oct;58 Suppl 10:S94-S107. doi: 10.1002/jcph.1092.
Reference Type
BACKGROUND
Williams CF, Bustamante EE, Waller JL, Davis CL. Exercise effects on quality of life, mood, and self-worth in overweight children: the SMART randomized controlled trial. Transl Behav Med. 2019 May 16;9(3):451-459. doi: 10.1093/tbm/ibz015.
Reference Type
BACKGROUND
Styne DM, Arslanian SA, Connor EL, Farooqi IS, Murad MH, Silverstein JH, Yanovski JA. Pediatric Obesity-Assessment, Treatment, and Prevention: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2017 Mar 1;102(3):709-757. doi: 10.1210/jc.2016-2573.
Reference Type
BACKGROUND
Al-Khudairy L, Loveman E, Colquitt JL, Mead E, Johnson RE, Fraser H, Olajide J, Murphy M, Velho RM, O'Malley C, Azevedo LB, Ells LJ, Metzendorf MI, Rees K. Diet, physical activity and behavioural interventions for the treatment of overweight or obese adolescents aged 12 to 17 years. Cochrane Database Syst Rev. 2017 Jun 22;6(6):CD012691. doi: 10.1002/14651858.CD012691.
Reference Type
BACKGROUND
Gallo S, Cheskin LJ. Treatment of Obesity: Beyond the Diet. Gastroenterol Clin North Am. 2021 Mar;50(1):113-125. doi: 10.1016/j.gtc.2020.10.003. Epub 2021 Jan 5.
Reference Type
BACKGROUND
Whitehead L, Glass CC, Abel SL, Sharp K, Coppell KJ. Exploring the role of goal setting in weight loss for adults recently diagnosed with pre-diabetes. BMC Nurs. 2020 Jul 15;19:67. doi: 10.1186/s12912-020-00462-6. eCollection 2020.
Reference Type
BACKGROUND
Saelens BE, Sallis JF, Wilfley DE, Patrick K, Cella JA, Buchta R. Behavioral weight control for overweight adolescents initiated in primary care. Obes Res. 2002 Jan;10(1):22-32. doi: 10.1038/oby.2002.4.
Reference Type
BACKGROUND
Liu X, Hanseman DJ, Champagne CM, Bray GA, Qi L, Williamson DA, Anton SD, Sacks FM, Tong J. Predicting Weight Loss Using Psychological and Behavioral Factors: The POUNDS LOST Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4):1274-83. doi: 10.1210/clinem/dgz236.
Reference Type
BACKGROUND
Lawrence JM, Divers J, Isom S, Saydah S, Imperatore G, Pihoker C, Marcovina SM, Mayer-Davis EJ, Hamman RF, Dolan L, Dabelea D, Pettitt DJ, Liese AD; SEARCH for Diabetes in Youth Study Group. Trends in Prevalence of Type 1 and Type 2 Diabetes in Children and Adolescents in the US, 2001-2017. JAMA. 2021 Aug 24;326(8):717-727. doi: 10.1001/jama.2021.11165.
Reference Type
BACKGROUND
Magge SN, Silverstein J, Elder D, Nadeau K, Hannon TS. Evaluation and Treatment of Prediabetes in Youth. J Pediatr. 2020 Apr;219:11-22. doi: 10.1016/j.jpeds.2019.12.061. Epub 2020 Mar 3. No abstract available.
Reference Type
BACKGROUND
Wallace AS, Wang D, Shin JI, Selvin E. Screening and Diagnosis of Prediabetes and Diabetes in US Children and Adolescents. Pediatrics. 2020 Sep;146(3):e20200265. doi: 10.1542/peds.2020-0265. Epub 2020 Aug 10.
Reference Type
BACKGROUND
Smith JD, Fu E, Kobayashi MA. Prevention and Management of Childhood Obesity and Its Psychological and Health Comorbidities. Annu Rev Clin Psychol. 2020 May 7;16:351-378. doi: 10.1146/annurev-clinpsy-100219-060201. Epub 2020 Feb 25.
Reference Type
BACKGROUND
Bendor CD, Bardugo A, Pinhas-Hamiel O, Afek A, Twig G. Cardiovascular morbidity, diabetes and cancer risk among children and adolescents with severe obesity. Cardiovasc Diabetol. 2020 Jun 13;19(1):79. doi: 10.1186/s12933-020-01052-1.
Reference Type
BACKGROUND
Rupp K, McCoy SM. Bullying Perpetration and Victimization among Adolescents with Overweight and Obesity in a Nationally Representative Sample. Child Obes. 2019 Jul;15(5):323-330. doi: 10.1089/chi.2018.0233. Epub 2019 May 7.
Reference Type
BACKGROUND
Fryar CD, Kruszon-Moran D, Gu Q, Ogden CL. Mean Body Weight, Height, Waist Circumference, and Body Mass Index Among Adults: United States, 1999-2000 Through 2015-2016. Natl Health Stat Report. 2018 Dec;(122):1-16.
Reference Type
BACKGROUND
Khera AV, Chaffin M, Wade KH, Zahid S, Brancale J, Xia R, Distefano M, Senol-Cosar O, Haas ME, Bick A, Aragam KG, Lander ES, Smith GD, Mason-Suares H, Fornage M, Lebo M, Timpson NJ, Kaplan LM, Kathiresan S. Polygenic Prediction of Weight and Obesity Trajectories from Birth to Adulthood. Cell. 2019 Apr 18;177(3):587-596.e9. doi: 10.1016/j.cell.2019.03.028.
Reference Type
BACKGROUND
Hoyt LT, Kushi LH, Leung CW, Nickleach DC, Adler N, Laraia BA, Hiatt RA, Yen IH. Neighborhood influences on girls' obesity risk across the transition to adolescence. Pediatrics. 2014 Nov;134(5):942-9. doi: 10.1542/peds.2014-1286. Epub 2014 Oct 13.
Reference Type
BACKGROUND
Hu EY, Ramachandran S, Bhattacharya K, Nunna S. Obesity Among High School Students in the United States: Risk Factors and Their Population Attributable Fraction. Prev Chronic Dis. 2018 Nov 8;15:E137. doi: 10.5888/pcd15.180122.
Reference Type
BACKGROUND
Akinbami LJ, Chen TC, Davy O, Ogden CL, Fink S, Clark J, Riddles MK, Mohadjer LK. National Health and Nutrition Examination Survey, 2017-March 2020 Prepandemic File: Sample Design, Estimation, and Analytic Guidelines. Vital Health Stat 1. 2022 May;(190):1-36.
Reference Type
BACKGROUND
Skinner AC, Ravanbakht SN, Skelton JA, Perrin EM, Armstrong SC. Prevalence of Obesity and Severe Obesity in US Children, 1999-2016. Pediatrics. 2018 Mar;141(3):e20173459. doi: 10.1542/peds.2017-3459.
Reference Type
BACKGROUND
The NS, Suchindran C, North KE, Popkin BM, Gordon-Larsen P. Association of adolescent obesity with risk of severe obesity in adulthood. JAMA. 2010 Nov 10;304(18):2042-7. doi: 10.1001/jama.2010.1635.
Reference Type
BACKGROUND
Wang Y, Beydoun MA, Min J, Xue H, Kaminsky LA, Cheskin LJ. Has the prevalence of overweight, obesity and central obesity levelled off in the United States? Trends, patterns, disparities, and future projections for the obesity epidemic. Int J Epidemiol. 2020 Jun 1;49(3):810-823. doi: 10.1093/ije/dyz273.
Reference Type
BACKGROUND
Ogden CL, Fryar CD, Martin CB, Freedman DS, Carroll MD, Gu Q, Hales CM. Trends in Obesity Prevalence by Race and Hispanic Origin-1999-2000 to 2017-2018. JAMA. 2020 Sep 22;324(12):1208-1210. doi: 10.1001/jama.2020.14590.
Reference Type
BACKGROUND
McDow KB, Nguyen DT, Herrick KA, Akinbami LJ. Attempts to Lose Weight Among Adolescents Aged 16-19 in the United States, 2013-2016. NCHS Data Brief. 2019 Jul;(340):1-8.
Reference Type
BACKGROUND
Kakinami L, Houle-Johnson SA, Demissie Z, Santosa S, Fulton JE. Meeting fruit and vegetable consumption and physical activity recommendations among adolescents intending to lose weight. Prev Med Rep. 2018 Oct 28;13:11-15. doi: 10.1016/j.pmedr.2018.10.021. eCollection 2019 Mar.
Reference Type
BACKGROUND
Lucchini M, O'Brien LM, Kahn LG, Brennan PA, Glazer Baron K, Knapp EA, Lugo-Candelas C, Shuffrey L, Dunietz GL, Zhu Y, Wright RJ, Wright RO, Duarte C, Karagas MR, Ngai P, O'Connor TG, Herbstman JB, Dioni S, Singh AM, Alcantara C, Fifer WP, Elliott AJ; Environmental influences on Child Health Outcomes. Racial/ethnic disparities in subjective sleep duration, sleep quality, and sleep disturbances during pregnancy: an ECHO study. Sleep. 2022 Sep 8;45(9):zsac075. doi: 10.1093/sleep/zsac075.
Reference Type
BACKGROUND
Alves JM, Chow T, Nguyen-Rodriguez S, Angelo B, Defendis A, Luo S, Smith A, Yunker AG, Xiang AH, Page KA. Associations Between Sleep and Metabolic Outcomes in Preadolescent Children. J Endocr Soc. 2022 Sep 19;6(11):bvac137. doi: 10.1210/jendso/bvac137. eCollection 2022 Oct 11.
Reference Type
BACKGROUND
Okoli A, Hanlon EC, Brady MJ. The Relationship between Sleep, Obesity, and Metabolic Health in Adolescents - a Review. Curr Opin Endocr Metab Res. 2021 Apr;17:15-19. doi: 10.1016/j.coemr.2020.10.007. Epub 2020 Nov 4.
Reference Type
BACKGROUND
Weiss A, Xu F, Storfer-Isser A, Thomas A, Ievers-Landis CE, Redline S. The association of sleep duration with adolescents' fat and carbohydrate consumption. Sleep. 2010 Sep;33(9):1201-9. doi: 10.1093/sleep/33.9.1201.
Reference Type
BACKGROUND
Wilfley DE, Kass AE, Kolko RP. Counseling and behavior change in pediatric obesity. Pediatr Clin North Am. 2011 Dec;58(6):1403-24, x. doi: 10.1016/j.pcl.2011.09.014.
Reference Type
BACKGROUND
Dicker D, Alfadda AA, Coutinho W, Cuevas A, Halford JCG, Hughes CA, Iwabu M, Kang JH, Nawar R, Reynoso R, Rhee N, Rigas G, Salvador J, Sbraccia P, Vazquez-Velazquez V, Caterson ID. Patient motivation to lose weight: Importance of healthcare professional support, goals and self-efficacy. Eur J Intern Med. 2021 Sep;91:10-16. doi: 10.1016/j.ejim.2021.01.019. Epub 2021 Feb 6.
Reference Type
BACKGROUND
Coppell KJ, Abel SL, Freer T, Gray A, Sharp K, Norton JK, Spedding T, Ward L, Whitehead LC. The effectiveness of a primary care nursing-led dietary intervention for prediabetes: a mixed methods pilot study. BMC Fam Pract. 2017 Dec 21;18(1):106. doi: 10.1186/s12875-017-0671-8.
Reference Type
BACKGROUND
Mitchell TB, Amaro CM, Steele RG. Pediatric weight management interventions in primary care settings: A meta-analysis. Health Psychol. 2016 Jul;35(7):704-713. doi: 10.1037/hea0000381. Epub 2016 Apr 18.
Reference Type
BACKGROUND
Channon SJ, Huws-Thomas MV, Rollnick S, Hood K, Cannings-John RL, Rogers C, Gregory JW. A multicenter randomized controlled trial of motivational interviewing in teenagers with diabetes. Diabetes Care. 2007 Jun;30(6):1390-5. doi: 10.2337/dc06-2260. Epub 2007 Mar 10.
Reference Type
BACKGROUND
Beals E, Deierlein A, Katzow M. Clinical interventions to increase vegetable intake in children. Curr Opin Pediatr. 2023 Feb 1;35(1):138-146. doi: 10.1097/MOP.0000000000001203. Epub 2022 Nov 17.
Reference Type
BACKGROUND
DeBar LL, Stevens VJ, Perrin N, Wu P, Pearson J, Yarborough BJ, Dickerson J, Lynch F. A primary care-based, multicomponent lifestyle intervention for overweight adolescent females. Pediatrics. 2012 Mar;129(3):e611-20. doi: 10.1542/peds.2011-0863. Epub 2012 Feb 13.
Reference Type
BACKGROUND
Tucker SJ, Ytterberg KL, Lenoch LM, Schmit TL, Mucha DI, Wooten JA, Lohse CM, Austin CM, Mongeon Wahlen KJ. Reducing pediatric overweight: nurse-delivered motivational interviewing in primary care. J Pediatr Nurs. 2013 Nov-Dec;28(6):536-47. doi: 10.1016/j.pedn.2013.02.031. Epub 2013 Mar 24.
Reference Type
BACKGROUND
Other Identifiers
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23-0375
Identifier Type: -
Identifier Source: org_study_id