Self-Weighing for Adolescents Seeking Obesity Treatment

NCT ID: NCT04837586

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2026-05-01

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. 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.

Detailed 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.

Conditions

Adolescent Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Care

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

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Simple Scale

Intervention Type: DEVICE

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

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).

Group Type: ACTIVE_COMPARATOR

EHR-Connected Scale

Intervention Type: 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.

Interventions

Standard Care

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

Intervention Type: OTHER

Simple Scale

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carolyn Bramante, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

M Health - Pediatric Weight Management Clinic

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carolyn Bramante, MD

Role: CONTACT

bramante@umn.edu

6126245624

Facility Contacts

Carolyn Bramante, MD

Role: primary

bramante@umn.edu

6126245624

Other Identifiers

PEDS-2021-29697

Identifier Type: -

Identifier Source: org_study_id