Supporting Lifestyle Changes After Delivery (STELLA)

Information and Communication Technology -Based Health Behavior Change Support System to Modify Lifestyle After Delivery: Randomized Controlled Intervention Study

Use of information and communication technology -based health behavior change support system in modifying lifestyle after delivery among women with obesity.

Study Overview

• Status: Recruiting
• Conditions: Lifestyle; Obesity, Maternal
• Intervention / Treatment: Device: Information and communication technology -based health behavior change support system

Detailed Description

Postpartum weight retention is common and particular when accompanied with prior obesity, it further increases the risks of subsequent pregnancies and adverse effects on the long-term health.

The aim of this randomized controlled trial is to examine whether using an information and communication technology (ICT) -based health behavior change support system (HBCSS) reduce postpartum weight retention and disorders related to subsequent pregnancy. Web-based HBCSS application utilizes persuasive design and cognitive behavioral therapy.

200 participants with prepregnancy obesity (BMI ≥ 30.0 kg/m^2) and age ≥ 18 years are randomly assigned into two groups after delivery in the Oulu university hospital. The study period begins 5-12 weeks after delivery. All participants will have conventional postpartum lifestyle counselling and the intervention group get in addition access for 12 months to web-based HBCSS application, which is recommended to use twice a week for 5-10 minutes.

Participants are followed by questionnaires up to 24 months. The main outcome is weight change from baseline to 12 and 24 months. Medical records and national registers are used for long-term follow-up. Researchers have permission to contact participants afterwards. The ethical approval is permitted by the Regional Medical Research Ethics Committee of the Wellbeing Services County of North Ostrobothnia. The authorization for the use of medical device is granted from the Finnish Medicines Agency. Recruitment of the participants will be performed 2/2024-1/2026.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sanna Mustaniemi, PhD; Phone Number: +358 8669 9500; Email: sanna.mustaniemi@oulu.fi
• Study Contact Backup: Name: Elina Keikkala, PhD; Email: elina.keikkala@oulu.fi

Study Locations

• Finland
  • Oulu, Finland, 90029
    • Recruiting
    • Oulu University Hospital
    • Contact: Sanna Mustaniemi, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pre-pregnancy BMI ≥ 30.0 kg/m^2
• Smartphone user

Exclusion Criteria:

• Eating disorder
• Severe mental disorder
• Use of other lifestyle support system or medication
• Non-Finnish speaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Device: Information and communication technology -based health behavior change support system; Information and communication technology -based health behavior change support system addition to conventional postpartum lifestyle education
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change	Weight change in kilograms and change of body mass index (kg/m^2)	12 months
Weight change	Weight change in kilograms and change of body mass index (kg/m^2)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight change before subsequent pregnancy	Weight change in kilograms and change of body mass index (kg/m^2)	1-8 years
Pregnancy disorders in subsequent pregnancy (gestational diabetes, pre-eclampsia, gestational hypertension, preterm delivery)	Number of participants with pregnancy disorders in subsequent pregnancy (gestational diabetes, pre-eclampsia, gestational hypertension, preterm delivery, mortality)	1-8 years
Neonatal outcome in subsequent pregnancy (preterm birth, large for gestational age, small for gestational age, need for neonatal intensive care, mortality)	Number of neonates with adverse neonatal outcome (preterm birth, large for gestational age, small for gestational age, need for neonatal intensive care, mortality)	1-8 years

Collaborators and Investigators

• Sponsor: Oulu University Hospital
• Collaborators: University of Oulu
• Investigators: Principal Investigator: Marja Vääräsmäki, Professor, Research Unit of Clinical Medicine, University of Oulu, Oulu University Hospital

Publications and helpful links

Helpful Links

• STELLA project page

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Pregnancy Complications; Obesity; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity, Maternal
• Other Study ID Numbers: 39/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No