Usability Study of Gestational and Postpartum Weight Management Program

NCT07272824 | Recruiting

• 1 other identifier: Hope-D usability study
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 individual weight management plan and individual or group coaching for weight management from pregnancy to 6 months postpartum.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week

Secondary Outcomes (3)

• Usability of gestational and postpartum digital pathway for weight management

  1 week

• Usability of gestational and postpartum general and individual weight management plan

  one week

• Usability of group and individual coaching sessions

  one week

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Gestational and postpartum weight management can be studied only in pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women in the wellbeing services county of Southwest Finland, Turku area

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Turku University Hospital: lead
• Hospital District of Helsinki and Uusimaa: collaborator
• University of Turku: collaborator
• University of Helsinki: collaborator

Study Sites (1)

The wellbeing services county of Southwest Finland

Turku, Finland, Finland

RECRUITING

Study Officials

• Kaarin Mäkikallio

  The wellbeing services county of Southwest Finland

  STUDY DIRECTOR

Central Study Contacts

Leila Varakas, PhD student

CONTACT

+358505213354; leila.varakas@varha.fi

Saila Koivusalo, sci leader

CONTACT

+358407250620; saila.koivusalo@hus.fi

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: December 9, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)