Self-Weighing for Adolescents Seeking Obesity Treatment

NCT04837586 | Recruiting

• 1 other identifier: PEDS-2021-29697
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

99 patients age 12 to \<18 years old with obesity (BMI \>/=95th percentile), will be randomized to one of three treatment interventions:

1. 1.Usual Care
2. 2.Usual Care plus advice to weigh daily on simple scale
3. 3.Usual Care plus advice to weigh-daily on an EHR-connected scale

Conditions

Adolescent Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (3)

• Feasibility of connecting the Smart scales to the EHR and access home weights through the EHR

  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.

  12 weeks

• Feasibility of collecting daily weights.

  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

  12 weeks

• Perceptions of daily weight tracking.

  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).

  12 weeks

Study Arms (3)

Standard Care

ACTIVE COMPARATOR

Individuals in this arm will receive standard care for their obesity in the Pediatric Weight Management Clinic

Other: Standard Care

Simple Scale

ACTIVE COMPARATOR

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.

Device: Simple Scale

EHR-Connected Scale

ACTIVE COMPARATOR

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).

Device: EHR-Connected Scale

Interventions

Standard Care OTHER

Individuals will receive standard care for their obesity through the Pediatric Weight Management Clinic.

Standard Care

Simple Scale DEVICE

Individuals will be encouraged to perform daily weighing at home on a simple scale.

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.

EHR-Connected Scale

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 12 to \< 18 years
• Body mass index (BMI) \>/= 95th percentile

You may not qualify if:

• 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
• Parent or legal guardian of the child participant
• Parent aged \> 18 years

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

M Health - Pediatric Weight Management Clinic

Minneapolis, Minnesota, 55454, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Carolyn Bramante, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn Bramante, MD

CONTACT

6126245624; bramante@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 8, 2021
• Study Start: September 15, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)