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

N

Norwegian University of Science and Technology

Status

Completed

Conditions

Gestational Diabetes
Pre-Eclampsia

Treatments

Behavioral: Web-based lifestyle intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT03993145
2018/1803

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of preeclampsia or gestational diabetes in recent pregnancy, confirmed by medical record review
  • capable to speak and read Norwegian
  • access to internet enabled mobile devices that use either iOS or Android operating systems

Exclusion criteria

  • Diagnosis of chronic hypertension or diabetes mellitus
  • current use of blood pressure lowering medication
  • medication known to affect glucose tolerance
  • active self-reported eating disorder
  • history of heart disease, stroke or kidney disease
  • history of gastric bypass or bowel surgery resulting in malabsorption
  • active medical problems that would interfere with following the diet, or with changes in blood pressure and/or weight

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

44 participants in 1 patient group

Web-based lifestyle intervention
Experimental group
Description:
participants will be provided access to web-based lifestyle intervention program with personalized coaching from a clinical dietician
Treatment:
Behavioral: Web-based lifestyle intervention

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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