Self-Weighing for Adolescents Seeking Obesity Treatment

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT04837586
Status
Recruiting

Conditions

  • Adolescent Obesity

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard Care — OTHER
    Individuals will receive standard care for their obesity through the Pediatric Weight Management Clinic.
  • Simple Scale — DEVICE
    Individuals will be encouraged to perform daily weighing at home on a simple scale.
  • EHR-Connected Scale — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Sep 15, 2023
Status verified
May 2026
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
99 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Care
    Individuals in this arm will receive standard care for their obesity in the Pediatric Weight Management Clinic
  • Active Comparator: Simple Scale
    Individuals in this arm will receive standard care for their obesity in the Pediatric Weight Management Clinic and will be encouraged to self-weigh daily utilizing a simple scale.
  • Active Comparator: EHR-Connected Scale
    Individuals in this arm will receive standard care for their obesity in the Pediatric Weight Management Clinic and will be encouraged to self-weigh daily utilizing a Smart scale that is connected to the Electronic Health Record (EHR).

Primary Outcome Measure

Feasibility of connecting the Smart scales to the EHR and access home weights through the EHR [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M Health - Pediatric Weight Management ClinicMinneapolisMinnesota55454
Carolyn Bramante, MD
612-624-5624

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