Health TrialsbyHealthPanel

Self-Weighing for Adolescents Seeking Obesity Treatment

ConditionAdolescent Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ages 12 to < 18 years

Body mass index (BMI) >/= 95th percentile

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard Care

    Other intervention

    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.

Treatment groups

99 Participants
are divided into 3 treatment groups
Group A: Standard CareActive comparator 1 intervention
Group B: Simple ScaleActive comparator 1 intervention
Group C: EHR-Connected ScaleActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

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

Time frame
12 weeks
3

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).

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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