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Идёт набор NCT04837586

Self-Weighing for Adolescents Seeking Obesity Treatment

Без фазы С лечением Adolescent Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Standard Care, Simple Scale, EHR-Connected Scale.
Кому может быть актуально
Состояния в реестре: Adolescent Obesity. Базовые параметры: 12 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое Standard Care
    Individuals will receive standard care for their obesity through the Pediatric Weight Management Clinic.
  • Устройство Simple Scale
    Individuals will be encouraged to perform daily weighing at home on a simple scale.
  • Устройство 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.

Первичные конечные точки

  • Feasibility of connecting the Smart scales to the EHR and access home weights through the EHR [Срок оценки: 12 weeks]
  • Feasibility of collecting daily weights. [Срок оценки: 12 weeks]
  • Perceptions of daily weight tracking. [Срок оценки: 12 weeks]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • M Health - Pediatric Weight Management Clinic — Minneapolis

Идентификаторы

NCT: NCT04837586 · PEDS-2021-29697

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗