Supporting Lifestyle Changes After Delivery

NCT06241144 | Recruiting DMC

• 1 other identifier: 39/2023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity, Maternal; Lifestyle

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Weight change before subsequent pregnancy

  1-8 years

• Pregnancy disorders in subsequent pregnancy (gestational diabetes, pre-eclampsia, gestational hypertension, preterm delivery)

  1-8 years

• Neonatal outcome in subsequent pregnancy (preterm birth, large for gestational age, small for gestational age, need for neonatal intensive care, mortality)

  1-8 years

Study Arms (2)

Intervention

EXPERIMENTAL

Device: Information and communication technology -based health behavior change support system

Control

NO INTERVENTION

Interventions

Information and communication technology -based health behavior change support system DEVICE

Information and communication technology -based health behavior change support system addition to conventional postpartum lifestyle education

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oulu University Hospital: lead
• University of Oulu: collaborator

Study Sites (1)

Oulu University Hospital

Oulu, 90029, Finland

RECRUITING

Related Links

• STELLA project page

MeSH Terms

Conditions

Pregnancy in Obesity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marja Vääräsmäki, Professor

  Research Unit of Clinical Medicine, University of Oulu, Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanna Mustaniemi, PhD

CONTACT

+358 8669 9500; sanna.mustaniemi@oulu.fi

Elina Keikkala, PhD

CONTACT

elina.keikkala@oulu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 5, 2024
• Study Start: February 9, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): December 31, 2032
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)