NCT03993145

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

February 7, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2021

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

June 18, 2019

Last Update Submit

May 11, 2021

Conditions

Pre-EclampsiaGestational Diabetes

Keywords

MentoringHealthy life stylePostpartum Period

Outcome Measures

Primary Outcomes (5)

  • Recruitment

    Proportion of eligible patients enrolled in the study

    baseline

  • Retention

    Proportion of participants kept in the study

    3 months

  • Retention

    Proportion of participants kept in the study

    6 months

  • Adherence

    Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)

    3 months

  • Adherence

    Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)

    6 months

Secondary Outcomes (12)

  • Adherence to Norwegian food-based dietary guidelines

    3 months

  • Adherence to Norwegian food-based dietary guidelines

    6 months

  • Changes in physical activity levels

    baseline, 3 months

  • Changes in physical activity levels

    baseline, 6 months

  • Changes in body weight

    Baseline, 3 months

  • +7 more secondary outcomes

Other Outcomes (1)

  • Participant satisfaction

    9 months

Study Arms (1)

Web-based lifestyle intervention

EXPERIMENTAL

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

Behavioral: Web-based lifestyle intervention

Interventions

Web-based lifestyle interventionBEHAVIORAL

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).

Web-based lifestyle intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Levanger sykehus

Levanger, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 37485436DERIVED

MeSH Terms

Conditions

Pre-EclampsiaDiabetes, Gestational

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Siri Forsmo, md prof

    Norwegian University of Science and Technology NTNU

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 20, 2019

Study Start

February 7, 2020

Primary Completion

May 4, 2021

Study Completion

May 4, 2021

Last Updated

May 12, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)