PregnancyHope-D_UseNCT07272824
Usability Study of Gestational and Postpartum Weight Management Program
An observational study of Pregnancy and Postpartum, run by Turku University Hospital at 1 site in Finland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Postpartum, Obese Pregnant Women
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- 9 Dec 2025to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women in the wellbeing services county of Southwest Finland, Turku area
Who may be able to join
- General pregnant women with prepregnancy BMI at least 30 kg/m2
- Competence in using the digital care pathway and electronic maternity card
Who cannot join
- Significant difficulty in cooperating (e.g. inadequate Finnish language skills)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
The wellbeing services county of Southwest Finland
Turku, Finland
Leila Varakas, +358404125945, Leila.varakas@varha.fi
About this study
Official title: Usability Study of Gestational and 6 Months Postpartum Weight Management Program - Hope D
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.
Read the detailed description
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
- Pregnancy, Postpartum, Obese Pregnant Women, Weight Management, Digital Intervention, Usability
- Keywords
- Hope-D, digital pathway, Gestational weight management, Postpartum weight management, gestational weight management plan, coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The basic version of Hope-D program has been developed
The aim of the Hope-D program is to develop a standardized model for gestational and postpartum weight management. The basic version of the Hope-D program will be considered ready for implementation in the subsequent intervention study once all sections of the System Usability Scale (SUS) reach a score above 68 within the same development period (sprint).
The SUS is a widely used, reliable, and valid instrument for evaluating the usability of various technologies, including digital products, systems, and services. It comprises ten statements rated on a five-point Likert scale, where 1 indicates strong disagreement and 5 indicates strong agreement. The total SUS score ranges from 0 to 100, with higher scores indicating better perceived usability. The SUS questionnaire has been translated into Finnish and is available for use free of charge.
Measured: 1 week
Secondary outcomes (3)
Usability of gestational and postpartum digital pathway for weight management
General technical questions will address the usability aspects and general thematic questions, e.g., motivation to manage weight during and after pregnancy with a digital pathway for weight management. Participants' responses will provide qualitative insights to guide the further development of the Hope-D program. The responses will not be quantitatively scored, as there are no right or wrong answers. Instead, the data will be analyzed using qualitative content analysis. Themes and issues that emerge most frequently across interviews will be considered the most relevant usability concerns and will be given higher priority in the development guidelines than those mentioned only occasionally.
Measured: 1 week
Usability of gestational and postpartum general and individual weight management plan
The general interview questions focus on the visibility and relevance of the weight management plan, the types of support perceived as motivational, clarity of goal-setting, and the appropriate timing for initiating and continuing weight management during pregnancy and in the postpartum period.
Participants' responses will inform the development of the Hope-D application. The data will be analyzed qualitatively; responses will not be scaled or scored, and there are no right or wrong answers. Recurring themes identified across multiple interviews will be considered indicative of common needs and prioritized accordingly in the development of the application guidelines. Themes mentioned in single interviews will also be noted but will receive lower priority in the guideline development process.
Measured: one week
Usability of group and individual coaching sessions
The general interview questions explore whether group or individual coaching sessions add value to the digital pathway for weight management and general weight management plan. Themes include the perceived usefulness of coaching, optimal number and spacing of sessions, and the suitability of specific topics for either individual or group coaching formats. The answers of participants give investigators the guidelines for the development of Hope-D application. The answers themselves won't be scored; there aren't wrong or correct answers. Answers which repeat most commonly in the interviews are the most common issues and they will have higher priority in the guideline than answers which arise only in one interview.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start9 Dec 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Hospital District of Helsinki and Uusimaa, University of Turku, University of Helsinki
- Responsible party
- Sponsor
- Investigators
- Kaarin Mäkikallio, Study director, The wellbeing services county of Southwest Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272824
- Sponsor's protocol ID
- Hope-D usability study
- Acronym
- Hope-D_Use
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: EU GDPR restricts data sharing
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Study of Gestational and 6 Months Postpartum Weight Management Program - Hope D
- ClinicalTrials.gov ID
- NCT07272824
- Acronym / sponsor ID
- Hope-D_Use / Hope-D usability study
- Conditions
- Pregnancy, Postpartum, Obese Pregnant Women, Weight Management, Digital Intervention, Usability
- Keywords
- Hope-D, digital pathway, Gestational weight management, Postpartum weight management, gestational weight management plan, coaching
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Hospital District of Helsinki and Uusimaa, University of Turku, University of Helsinki
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women in the wellbeing services county of Southwest Finland, Turku area
Key inclusion criteria (2 listed)
- General pregnant women with prepregnancy BMI at least 30 kg/m2
- Competence in using the digital care pathway and electronic maternity card
Key exclusion criteria (1 listed)
- Significant difficulty in cooperating (e.g. inadequate Finnish language skills)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The basic version of Hope-D program has been developed
Time frame: 1 week
The aim of the Hope-D program is to develop a standardized model for gestational and postpartum weight management. The basic version of the Hope-D program will be considered ready for implementation in the subsequent intervention study once all sections of the System Usability Scale (SUS) reach a score above 68 within the same development period (sprint). The SUS is a widely used, reliable, and valid instrument for evaluating the usability of various technologies, including digital products, systems, and services. It comprises ten statements rated on a five-point Likert scale, where 1 indicates strong disagreement and 5 indicates strong agreement. The total SUS score ranges from 0 to 100, with higher scores indicating better perceived usability. The SUS questionnaire has been translated into Finnish and is available for use free of charge.
3 secondary outcomes
Usability of gestational and postpartum digital pathway for weight management
Time frame: 1 week
Usability of gestational and postpartum general and individual weight management plan
Time frame: one week
Usability of group and individual coaching sessions
Time frame: one week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No. EU GDPR restricts data sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaarin Mäkikallio study director
The wellbeing services county of Southwest Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Postpartum, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leila Varakas, PhD student (+358505213354, leila.varakas@varha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The basic version of Hope-D program has been developed (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.