Clinical Trials Logo

Clinical Trial Summary

99 patients age 12 to <18 years old with obesity (BMI >/=95th percentile), will be randomized to one of three treatment interventions: 1. Usual Care 2. Usual Care plus advice to weigh daily on simple scale 3. Usual Care plus advice to weigh-daily on an EHR-connected scale Survey data collected at baseline, 2, 4, 6, and 12-weeks, and qualitative interviews at 12 weeks, will assess acceptability, safety, self-efficacy, and BMI. Recruitment will also be assessed (% eligible patients who consent). In order to understand real-world feasibility of this intervention, the clinic staff will work with patients to connect the scales to Epic.


Clinical Trial Description

Obesity is a major public health issue because of its high prevalence and many health consequences. Obesity is driven by a dysregulation of the body's energy regulatory systems and is life-shortening. Obesity during the critical adolescent period increases risk of diabetes, cardiometabolic disease, all-cause mortality, and adulthood obesity. Rates of obesity-related cancers are increasing in younger populations. In addition to poorer health, individuals with obesity during adolescence are at risk for lower productivity, income, and likelihood of employment in adulthood, making obesity treatment and prevention important for reducing disparities. Despite consensus on the need for multi-component interventions for obesity, rates continue to climb for adolescents, youth of low-income backgrounds, and youth of racial/ethnic minority backgrounds. Clinicians cite lack of time and tools to help patients lose weight as barriers to weight counseling, and thus need practical, effective interventions they can feasibly disseminate from a busy clinical setting. Self-weighing, grounded in behavior change theory, is effective for weight loss in adults. Self-monitoring is grounded in Social Cognitive Theory (SCT), which describes behavior change as happening with reciprocal interactions with one's environment, creating external and internal self-reinforcement. Self-monitoring is one such interaction that improves self-awareness through proximate self-measurement, and improves self-efficacy, self-control, and self-reinforcement. Self-weighing (SW) is a form of self-monitoring for weight loss that is grounded in SCT. Daily SW in adults has been associated with increased exercise and cognitive restraint, and reduced snacking, television watching, and consumption of sweets. The investigator found no data on patient and parent perspectives on connecting scales to the EHR for daily weights in adolescents with obesity seeking obesity treatment. 99 patients age 12 to <18 years old with obesity (BMI >/=95th percentile), to be randomized to one of three treatment interventions: 1. Usual Care 2. Usual Care plus advice to weigh daily on simple scale 3. Usual Care plus advice to weigh-daily on an EHR-connected scale Survey data collected at baseline, 2, 4, 6, and 12-weeks, and qualitative interviews at 12 weeks, will assess acceptability, safety, self-efficacy, and BMI. Recruitment will also be assessed (% eligible patients who consent). In order to understand real-world feasibility of this intervention, the clinic staff will work with patients to connect the scales to Epic. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04837586
Study type Interventional
Source University of Minnesota
Contact Carolyn Bramante, MD
Phone 6126245624
Email bramante@umn.edu
Status Recruiting
Phase N/A
Start date September 15, 2023
Completion date March 15, 2025

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05530356 - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Recruiting NCT05008276 - Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
Not yet recruiting NCT04310371 - Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise (CARDIBOX) N/A
Not yet recruiting NCT03203161 - Registry on Obesity Surgery in Adolescents
Completed NCT03364205 - Solution Focused Approach in Adolescents (SFA) N/A
Completed NCT05329753 - Effectiveness of a Mobile Health Intervention for the Prevention of Overweight and Obesity in Adolescents N/A
Active, not recruiting NCT03843424 - Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers N/A
Completed NCT03516097 - TeenPower: e-Empowering Teenagers to Prevent Obesity N/A
Active, not recruiting NCT04522921 - Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns N/A
Active, not recruiting NCT03584217 - Renal HEIR Study: Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study Phase 1/Phase 2
Active, not recruiting NCT03620773 - Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes Phase 1/Phase 2
Recruiting NCT03263351 - Depression & Insulin Sensitivity in Adolescents N/A
Completed NCT03458637 - Lifestyle Intervention of Obese Teenagers (LITE) Program N/A
Recruiting NCT05540678 - The FibreGum Study - Changing the Course of Obesity in Children N/A
Active, not recruiting NCT04007393 - SMART Use of Medication for the Treatment of Adolescent Severe Obesity Phase 2
Active, not recruiting NCT03587727 - Hepatic Mitochondrial Function in Youth
Not yet recruiting NCT04112251 - Effects of COcoa Supplement in OBese Adolescent Subjects N/A
Recruiting NCT05623007 - Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection N/A
Completed NCT03516721 - Chronotropic Incompetence During Exercise in Obese Adolescents: Clinical Implications and Pathophysiology N/A
Active, not recruiting NCT03919929 - Treating PCOS With Semaglutide vs Active Lifestyle Intervention Phase 2/Phase 3