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

NCT ID: NCT03993145

Last Updated: 2021-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-07

Study Completion Date

2021-05-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pre-Eclampsia Gestational Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Web-based lifestyle intervention

participants will be provided access to web-based lifestyle intervention program with personalized coaching from a clinical dietician

Group Type EXPERIMENTAL

Web-based lifestyle intervention

Intervention Type BEHAVIORAL

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Siri Forsmo, md prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology NTNU

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Levanger sykehus

Levanger, , Norway

Site Status

St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

Horn J, Kolberg M, Rangul V, Magnussen EB, Asvold BO, Henriksen HB, Blomhoff R, Seely EW, Rich-Edwards J. Feasibility of a Postpartum Web- and Phone-Based Lifestyle Program for Women with a History of Preeclampsia or Gestational Diabetes: A Pilot Intervention Study. Womens Health Rep (New Rochelle). 2023 Jul 18;4(1):345-357. doi: 10.1089/whr.2023.0039. eCollection 2023.

Reference Type DERIVED
PMID: 37485436 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018/1803

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Preeclampsia Intervention Netherlands
NCT06452498 NOT_YET_RECRUITING PHASE3
MumCare: Mum's Cardiovascular Health for Life
NCT05835596 ENROLLING_BY_INVITATION NA
Healthy Living in Pregnancy
NCT01958307 COMPLETED NA