NCT04837586 · University of Minnesota
Self-Weighing for Adolescents Seeking Obesity Treatment
What this study is about
99 patients age 12 to \<18 years old with obesity (BMI \>/=95th percentile), will be randomly assigned to one of three treatment interventions: 1. Usual Care 2. Usual Care plus advice to weigh daily on simple scale 3.
View original scientific description
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.
Interventions
OTHER
Standard Care
Individuals will receive standard care for their obesity through the Pediatric Weight Management Clinic.
DEVICE
Simple Scale
Individuals will be encouraged to perform daily weighing at home on a simple scale.
DEVICE
EHR-Connected Scale
Individuals will be encouraged to perform daily weighing at home on a Smart scale that connects to the EHR. Clinic staff will review weight entries in the EHR and provide feedback.
Primary outcome measures
Feasibility of connecting the Smart scales to the EHR and access home weights through the EHR
Time frame: 12 weeks
Feasibility will be measured by determining if the clinic staff can successfully connect scales to the EHR and access home weights through the EHR. Staff will record time required to connect the scale, answer questions and trouble-shoot problems that arise with the scale between visits to understand the time burden of this intervention.
Feasibility of collecting daily weights.
Time frame: 12 weeks
Participants who are randomized to the simple scale and the EHR-connected scale will be asked to weigh themselves daily (which we anticipate will be 5-7 days per week). Participants who were randomized to the EHR-connected device will have their adherence measured by looking at the EHR to see how many daily weights were completed. Participants randomized to the simple scale will be self-reporting how many times per week they weighed themselves at home with the simple scale
Perceptions of daily weight tracking.
Time frame: 12 weeks
Participants who are randomized to perform daily weighing on a simple scale and on an EHR-connected scale will be asked about their perceptions of having to perform this task on a daily basis via a questionnaire. The questionnaire will be a Likert scale from 0 (not helpful, not motivated, not interesting, not satisfying) to 8 (extremely helpful, extremely motivated, extremely interesting, extremely satisfying).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for Adolescent:
- Ages 12 to \< 18 years
- Body mass index (BMI) \>/= 95th percentile
Exclusion criteria
- for Adolescent:
- Score over 20 on the Eating Attitudes Test (EAT-26)
- Any unhealthy weight control behaviors
- Severe anxiety or depression
- Participation in another Pediatric Weight Management Clinic study
- Developmental delay
- Significant co-morbidity that might cause weight fluctuations in weight
- Current participation in a weight loss research study Inclusion Criteria for Parent:
- Parent or legal guardian of the child participant
- Parent aged \> 18 years
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 20, 2026 · Source of record for eligibility and locations