PreDiabetesNCT06067451
SMART GOALS for Youth With Prediabetes
A study testing SMART GOALS Setting Tool/ Protocol in people with PreDiabetes and Adolescent Obesity, run by Northwell Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- PreDiabetes, Adolescent Obesity, Behavior, Health
- What is being tested?
- SMART GOALS Setting Tool/ Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Dec 2023to 27 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Northwell Health
New York, New York, 11042
Rashida Talib, MPH, 516-472-3631, rtalib@northwell.edu
Nessa Wardak, 516-472-3631, nwardak@northwell.edu
- Recruiting
Northwell Health
New York, New York, 11042
Thomas Zachmann
About this study
Official title: Impact of SMART GOAL Setting Protocol on Body Weight and Metabolic Parameters in Children and Adolescents With Prediabetes; a Randomized Clinical Trial.
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.
Read the detailed description
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.
- Conditions
- PreDiabetes, Adolescent Obesity, Behavior, Health, Nutritional and Metabolic Diseases, Diet Habit, Lifestyle Risk Reduction
- Being tested
- SMART GOALS Setting Tool/ Protocol
- Keywords
- Nutrition
- Medical subject headings
- Prediabetic State, Pediatric Obesity, Health Behavior, Nutritional and Metabolic Diseases, Feeding Behavior, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART GOALS Setting Tool/ ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (2)
Temporal changes in Hemoglobin A1c between the study and control groups
A1c will be drawn every 3 months.
Measured: 3 months
Temporal changes in Lipids
Lipid panel to be drawn at baseline and again at 6 months if show elevation are detected per standard of care
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start10 Dec 2023
- Primary completion27 Feb 2027 (estimated)
- Study completion27 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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".
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin U. Nwosu, MD, Principal investigator, NORTHWELL HEALTH, INC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067451
- Sponsor's protocol ID
- 23-0375
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32487284Flechtner-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.
PubMed 22104037Han 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.
PubMed 20451244Daniels 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.
PubMed 19363511Wing 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.
PubMed 21593294Weiss 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.
PubMed 15793193Diabetes 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.
PubMed 12453955Kelley 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.
PubMed 26896208International 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.
PubMed 19371154Armstrong 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.
PubMed 31656225Ameer 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.
PubMed 30248198Williams 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.
PubMed 31094443Styne 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.
PubMed 28359099Al-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.
PubMed 28639320Gallo 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.
PubMed 33518158