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SMART GOALS for Youth With Prediabetes

Impact of SMART GOAL Setting Protocol on Body Weight and Metabolic Parameters in Children and Adolescents With Prediabetes; a Randomized Clinical Trial.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether setting clear, realistic goals and tracking them each week helps youth ages 10–18 with extra body weight and prediabetes. Prediabetes means blood sugar is higher than normal but not high enough to be diabetes. Over 6 months, the study compares weight, blood sugar, blood fats, diet, and physical activity in youth who use the goal tools and those who do not.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 10–18 at the first visit.
  • Body mass index (BMI), a measure of weight compared with height, at or above the 85th percentile for age and sex.
  • A1c, a blood test that measures average blood sugar, from 5.7% to 6.4% at the first visit.

Who can't join

  • Under age 10, unable to agree to take part, or not interested in weight loss or changes to food and daily habits.
  • Known diabetes and use of medicines that affect blood sugar or blood fats, such as insulin, metformin, GLP-1 medicines, statins, or Accutane.
  • Use of medicines that can change body weight, including antidepressants, steroids, or stimulants.
  • Learning or intellectual disabilities listed in the medical record, such as trouble with thinking and learning or autism.
  • Mental health conditions listed in the medical record, such as schizophrenia, depression, bipolar disorder, or psychosis.
  • Known medical conditions, including hormone problems, Cushing's syndrome, or other illness affecting the body.
  • A known or suspected eating disorder in the medical record, or obesity linked to genes or a syndrome.
  • Pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 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

Study sites (2)

NY