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Идёт набор NCT07272824

Usability Study of Gestational and Postpartum Weight Management Program

Наблюдательное Pregnancy Postpartum Obese Pregnant Women Weight Management

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Pregnancy, Postpartum, Obese Pregnant Women, Weight Management. Базовые параметры: 18 лет — 50 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Финляндия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Usability Study of Gestational and 6 Months Postpartum Weight Management Program - Hope D

Обзор

The principal aim of this study is to evaluate the usability of the Hope-D gestational and 6 months postpartum weight management program. We will evaluate the usability, functionality, and acceptability of the developed Hope-D weight management program that includes digital pathway for weight management, general or individual weight management plan and individual or group coaching for weight management from pregnancy to 6 months postpartum.

Подробное описание

The usability of the digital pathway will be evaluated through a one-week user test among up to 30 pregnant women, who have prepregnancy BMI at least 30 kg/m2.

Participants will use the Health Village digital pathway for gestational and 6 months postpartum weight management, after which they will take part in semi-structured interviews conducted via Microsoft Teams and complete the System Usability Scale (SUS) questionnaire assessing perceived acceptability and usability.

All interviews will be audio-recorded, transcribed verbatim, and analyzed qualitatively.

Participants will report whether they accessed the pathway via mobile phone or computer and evaluate the technical usability, including ease of login, fluency of navigation, functionality of links, and the overall visual design.

The content of the digital pathway will be assessed in terms of relevance, usefulness, completeness, and clarity. Participants will be asked whether all key topics were covered, which elements were most beneficial or motivating, and whether the content was appropriate for both the gestational and postpartum periods.

All participants will provide feedback on the weight management plan. Participants will review the general plan and the individual plan. Feedback will address the perceived suitability of the plan to support gestational and postpartum weight management, appropriateness of the six-month postpartum evaluation point, and the feasibility of presenting the plan in the digital maternity card.

All participants will evaluate the group coaching component. After reviewing the session themes, they will assess the added value of group coaching, appropriateness of session content and timing, complementarity to standard care, and preferences for individual coaching.

Similarly, participants will evaluate the individual coaching component, assessing its added value, appropriateness of content and timing, complementarity to standard care, and potential preference for group-based coaching.

Первичные конечные точки

  • The basic version of Hope-D program has been developed [Срок оценки: 1 week]
Вторичные конечные точки (3)
  • Usability of gestational and postpartum digital pathway for weight management [Срок оценки: 1 week]
  • Usability of gestational and postpartum general and individual weight management plan [Срок оценки: one week]
  • Usability of group and individual coaching sessions [Срок оценки: one week]

Критерии участия

Критерии включения

  • General pregnant women with prepregnancy BMI at least 30 kg/m2
  • Competence in using the digital care pathway and electronic maternity card

Критерии исключения

\- Significant difficulty in cooperating (e.g. inadequate Finnish language skills)

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Финляндия · 1 центр
  • The wellbeing services county of Southwest Finland — Turku

Идентификаторы

NCT: NCT07272824 · Hope-D usability study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗