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

Overview

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.

Full Title of Study: “Lifestyle Intervention for Women With Recent Pre-eclampsia or Gestational Diabetes Mellitus: A Pilot Intervention Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 4, 2021

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).

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Recruitment
    • Time Frame: baseline
    • Proportion of eligible patients enrolled in the study
  • Retention
    • Time Frame: 3 months
    • Proportion of participants kept in the study
  • Retention
    • Time Frame: 6 months
    • Proportion of participants kept in the study
  • Adherence
    • Time Frame: 3 months
    • Proportion of participants following study program (visiting the study’s website and having scheduled phone conversations with the dietician)
  • Adherence
    • Time Frame: 6 months
    • Proportion of participants following study program (visiting the study’s website and having scheduled phone conversations with the dietician)

Secondary Measures

  • Adherence to Norwegian food-based dietary guidelines
    • Time Frame: 3 months
    • We will use the NORDIET food frequency questionnaire to measure adherence to the qualitative recommendations of the Norwegian food-based dietary guidelines (FBDG) (Henriksen et al. 2018). We will measure the proportion of participants complying with the Norwegian FBDG.
  • Adherence to Norwegian food-based dietary guidelines
    • Time Frame: 6 months
    • We will use the NORDIET food frequency questionnaire to measure adherence to the qualitative recommendations of the Norwegian food-based dietary guidelines (Henriksen et al. 2018). We will measure the proportion of participants complying with the Norwegian FBDG.
  • Changes in physical activity levels
    • Time Frame: baseline, 3 months
    • Changes in physical activity levels assessed by physical activity sensors (two tri-axial accelerometers, AX3 Axivity, one on the thigh and second on lower back)
  • Changes in physical activity levels
    • Time Frame: baseline, 6 months
    • Changes in physical activity levels assessed by physical activity sensors (two tri-axial accelerometers, AX3 Axivity, one on the thigh and second on lower back)
  • Changes in body weight
    • Time Frame: Baseline, 3 months
    • Changes in body weight measured in kilograms
  • Changes in body weight
    • Time Frame: Baseline, 6 months
    • Changes in body weight measured in kilograms
  • Changes in blood pressure
    • Time Frame: Baseline, 3 months
    • Changes in blood pressure in mmHg (measured three times at 1-minute intervals after the participant has come to rest, using an automatic oscillometric method with cuff size adjusted to arm circumference)
  • Changes in blood pressure
    • Time Frame: Baseline, 6 months
    • Changes in blood pressure in mmHg (measured three times at 1-minute intervals after the participant has come to rest, using an automatic oscillometric method with cuff size adjusted to arm circumference)
  • Changes in total cholesterol
    • Time Frame: Baseline, 3 months
    • Changes in total cholesterol measured in mmol/l in non fasting blood samples
  • Changes in total cholesterol
    • Time Frame: Baseline, 6 months
    • Changes in total cholesterol measured in mmol/l in non fasting blood samples
  • Changes in HbA1c
    • Time Frame: Baseline, 3 months
    • Changes in HbA1c measured in mmol/l in non fasting blood samples
  • Changes in HbA1c
    • Time Frame: Baseline, 6 months
    • Changes in HbA1c measured in mmol/l in non fasting blood samples

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Norwegian University of Science and Technology
  • Collaborator
    • Harvard Medical School (HMS and HSDM)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Siri Forsmo, md prof, Study Director, Norwegian University of Science and Technology NTNU

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.