Usability Study of Gestational and Postpartum Weight Management Program

NCT ID: NCT07272824

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-09

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy Postpartum Obese Pregnant Women Weight Management Digital Intervention Usability

Keywords

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Hope-D digital pathway Gestational weight management Postpartum weight management gestational weight management plan coaching

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Usability of digital pathway, general/individual weight management plan and group/individual coachin

The participants will evaluate the digital pathway with a general and an individual gestational and 6 months postpartum weight management plan and group as well as individual coaching provided by a trained study nurse.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital District of Helsinki and Uusimaa

OTHER

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kaarin Mäkikallio

Role: STUDY_DIRECTOR

The wellbeing services county of Southwest Finland

Locations

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The wellbeing services county of Southwest Finland

Turku, Finland, Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Leila Varakas, PhD student

Role: CONTACT

Phone: +358505213354

Email: [email protected]

Saila Koivusalo, sci leader

Role: CONTACT

Phone: +358407250620

Email: [email protected]

Facility Contacts

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Leila Varakas

Role: primary

Other Identifiers

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Hope-D usability study

Identifier Type: -

Identifier Source: org_study_id