SMART GOALS for Youth With Prediabetes

NCT06067451 | Unknown

• 1 other identifier: 23-0375
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

PreDiabetes; Adolescent Obesity; Behavior, Health; Nutritional and Metabolic Diseases; Diet Habit; Lifestyle Risk Reduction

Keywords

Nutrition

Outcome Measures

Primary Outcomes (1)

• To determine the impact of SMART Goal setting on BMI z-scores To determine the impact of SMART Goal setting on BMI z-scores

  To determine the impact of SMART Goal setting on BMI z-scores, will assess anthropometrics at baseline, month 3 and at final visit (month 6)

  6 months

Secondary Outcomes (2)

• Temporal changes in Hemoglobin A1c between the study and control groups

  3 months

• Temporal changes in Lipids

  6 months

Study Arms (2)

SMART GOAL Arm

EXPERIMENTAL

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).

Behavioral: SMART GOALS Setting Tool/ Protocol

Standard of Care Arm

NO INTERVENTION

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:

Interventions

SMART GOALS Setting Tool/ Protocol 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.

SMART GOAL Arm

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children between ages 10-18 years at baseline visit
• Children with BMI for age and sex ≥ 85th percentile at baseline visit
• Children with hemoglobin A1c 5.7% to 6.4% at baseline visit

You may not qualify if:

• Children who are not able to provide assent to the study
• Children less than 10 years in age
• Children that are not interested in weight loss or diet and lifestyle change
• 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).
• Children on medications that can alter body weight (including antidepressants, steroids, stimulants).
• Children with documented learning and/or intellectual disabilities as identified through the electronic medical record (such as cognitive disability or autism spectrum disorder)
• Children with known psychiatric disorders disabilities as identified through the electronic medical record (e.g., schizophrenia, depression, bipolar disorder, or psychosis
• Children that have known medical conditions, including endocrine dysfunction, Cushing's Syndrome, or other systemic illness
• Children with known or suspected eating disorders as identified through the electronic medical record
• Children that have known genetic or syndromic obesity
• Female children who are pregnant

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (2)

Northwell Health

New York, New York, 11042, United States

RECRUITING

Northwell Health

New York, New York, 11042, United States

RECRUITING

Related Publications (47)

• 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.

  PMID: 32487284 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.

  PMID: 22104037 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.

  PMID: 20451244 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.

  PMID: 19363511 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.

  PMID: 21593294 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.

  PMID: 15793193 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.

  PMID: 12453955 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.

  PMID: 26896208 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.

  PMID: 19371154 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.

  PMID: 31656225 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.

  PMID: 30248198 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.

  PMID: 31094443 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.

  PMID: 28359099 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.

  PMID: 28639320 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.

  PMID: 33518158 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.

  PMID: 32684841 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.

  PMID: 11786598 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.

  PMID: 31802116 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.

  PMID: 34427600 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.

  PMID: 32143933 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.

  PMID: 32778539 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.

  PMID: 32097572 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.

  PMID: 32534575 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.

  PMID: 31062988 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.

  PMID: 30707668 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.

  PMID: 31002795 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.

  PMID: 25311606 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.

  PMID: 30412690 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.

  PMID: 35593699 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.

  PMID: 29483202 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.

  PMID: 21063014 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.

  PMID: 32016289 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.

  PMID: 32857101 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.

  PMID: 31442192 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.

  PMID: 30456053 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.

  PMID: 35724979 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.

  PMID: 36249413 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.

  PMID: 33283071 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.

  PMID: 20857867 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.

  PMID: 22093859 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.

  PMID: 33558163 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.

  PMID: 29268719 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.

  PMID: 27089458 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.

  PMID: 17351283 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.

  PMID: 36385196 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.

  PMID: 22331335 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.

  PMID: 23531463 BACKGROUND

MeSH Terms

Conditions

Prediabetic State; Pediatric Obesity; Health Behavior; Nutritional and Metabolic Diseases; Feeding Behavior; Risk Reduction Behavior

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Behavior, Animal

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Benjamin U. Nwosu, MD

  NORTHWELL HEALTH, INC.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Zachmann, RD

CONTACT

(516) 472-3750; tzachmann@northwell.edu

Rashida Talib, MPH

CONTACT

(516)472-3631; rtalib@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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".

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: October 4, 2023
• Study Start: December 10, 2023
• Primary Completion: November 10, 2025
• Study Completion: December 10, 2025
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

US (2)