Skip to main content
OpenTrials
Completed

NCT Number: NCT03993145

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pre-eclampsia Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Glucose Metabolism Disorders Hypertension, Pregnancy-Induced Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Levanger sykehus, Levanger, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web-based lifestyle intervention

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).

Primary outcomes

  1. Recruitment

    Time frame: baseline

    Proportion of eligible patients enrolled in the study

  2. Retention

    Time frame: 3 months

    Proportion of participants kept in the study

  3. Retention

    Time frame: 6 months

    Proportion of participants kept in the study

  4. Adherence

    Time frame: 3 months

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

  5. 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 outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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)

  5. Changes in body weight

    Time frame: Baseline, 3 months

    Changes in body weight measured in kilograms

  6. Changes in body weight

    Time frame: Baseline, 6 months

    Changes in body weight measured in kilograms

  7. 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)

  8. 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)

  9. Changes in total cholesterol

    Time frame: Baseline, 3 months

    Changes in total cholesterol measured in mmol/l in non fasting blood samples

  10. Changes in total cholesterol

    Time frame: Baseline, 6 months

    Changes in total cholesterol measured in mmol/l in non fasting blood samples

  11. Changes in HbA1c

    Time frame: Baseline, 3 months

    Changes in HbA1c measured in mmol/l in non fasting blood samples

  12. Changes in HbA1c

    Time frame: Baseline, 6 months

    Changes in HbA1c measured in mmol/l in non fasting blood samples

Other outcomes

  1. Participant satisfaction

    Time frame: 9 months

    Participants will complete qualitative surveys and participate in semi-structured interviews to measure their satisfaction with the intervention program.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Harvard Medical School (HMS and HSDM)
  • Helse Nord-Trøndelag HF
  • St. Olavs Hospital
  • University of Oslo

Registry information

Official study title

Lifestyle Intervention for Women With Recent Pre-eclampsia or Gestational Diabetes Mellitus: A Pilot Intervention Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 20, 2019
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.