Self-Weighing for Adolescents Seeking Obesity Treatment

Adolescent Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04837586
• Other study ID #: PEDS-2021-29697
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: March 15, 2025

Study information

• Verified date: November 2023
• Source: University of Minnesota
• Contact: Carolyn Bramante, MD
• Phone: 6126245624
• Email: bramante[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: March 15, 2025
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Obesity
• Obesity
• Pediatric Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	M Health - Pediatric Weight Management Clinic	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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