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Lifestyle Intervention for Women With Recent Pre-eclampsia or Gestational Diabetes Mellitus ('Mom's Healthy Heart')

NCT03993145 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-05-12

No results posted yet for this study

Summary

The aim of this pilot intervention study is to develop and test a tailored web-based lifestyle modification program for women with recent preeclampsia or gestational diabetes. Women will start the study 3-15 months postpartum. After obtaining written informed consent and confirmation of eligibility criteria, eligible women will be included in the pilot study using a single arm study design (all women will be assigned to the lifestyle intervention program). Participants will be provided access to a web-based lifestyle intervention program with personalized coaching from a registered dietician.

Conditions

  • Pre-Eclampsia
  • Gestational Diabetes

Interventions

BEHAVIORAL

Web-based lifestyle intervention

Lifestyle intervention program including educational modules on diet and physical activity with visual and audio. Phone conversation with the clinical dietician at week 1, week 3, week 6, week 12 and month 6 (completion of the study).

Sponsors & Collaborators

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • Helse Nord-Trøndelag HF

    collaborator OTHER

  • St. Olavs Hospital

    collaborator OTHER

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Siri Forsmo, md prof · Norwegian University of Science and Technology NTNU

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-07
Primary Completion
2021-05-04
Completion
2021-05-04

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03993145 on ClinicalTrials.gov