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NCT Number: NCT04837586

Self-Weighing for Adolescents Seeking Obesity Treatment

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M Health - Pediatric Weight Management Clinic

Minneapolis, Minnesota, 55454, United States

Location status: Recruiting

Location contact

Carolyn Bramante, MD

CONTACT

[email protected]

612-624-5624

About this study

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:

  • Usual Care
  • Usual Care plus advice to weigh daily on simple scale
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Carolyn Bramante, MD

CONTACT

[email protected]

6126245624

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Self-weighing for Weight Management in Adolescents Seeking Obesity Treatment: A Randomized Pilot

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2021
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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