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Self-Weighing for Adolescents Seeking Obesity Treatment

Primary Purpose

Adolescent Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Care
Simple Scale
EHR-Connected Scale
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Obesity focused on measuring Obesity

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M Health - Pediatric Weight Management Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Standard Care

Simple Scale

EHR-Connected Scale

Arm Description

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

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.

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).

Outcomes

Primary Outcome Measures

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.
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
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).

Secondary Outcome Measures

Full Information

First Posted
March 30, 2021
Last Updated
August 2, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT04837586
Brief Title
Self-Weighing for Adolescents Seeking Obesity Treatment
Official Title
Self-weighing for Weight Management in Adolescents Seeking Obesity Treatment: A Randomized Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
December 15, 2024 (Anticipated)
Study Completion Date
March 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
99 patients age 12 to <18 years old with obesity (BMI >/=95th percentile), will 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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Obesity
Keywords
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Individuals in this arm will receive standard care for their obesity in the Pediatric Weight Management Clinic
Arm Title
Simple Scale
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EHR-Connected Scale
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Individuals will receive standard care for their obesity through the Pediatric Weight Management Clinic.
Intervention Type
Device
Intervention Name(s)
Simple Scale
Intervention Description
Individuals will be encouraged to perform daily weighing at home on a simple scale.
Intervention Type
Device
Intervention Name(s)
EHR-Connected Scale
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of connecting the Smart scales to the EHR and access home weights through the EHR
Description
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.
Time Frame
12 weeks
Title
Feasibility of collecting daily weights.
Description
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
Time Frame
12 weeks
Title
Perceptions of daily weight tracking.
Description
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).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolyn Bramante, MD
Phone
6126245624
Email
bramante@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Bramante, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
M Health - Pediatric Weight Management Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Bramante, MD
Phone
612-624-5624
Email
bramante@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Self-Weighing for Adolescents Seeking Obesity Treatment

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