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

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

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.

Study Overview

• Status: Completed
• Conditions: Pre-Eclampsia; Gestational Diabetes
• Intervention / Treatment: Behavioral: Web-based lifestyle intervention

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Levanger, Norway
    • Levanger sykehus
  • Trondheim, Norway
    • St Olavs hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Web-based lifestyle intervention; participants will be provided access to web-based lifestyle intervention program with personalized coaching from a clinical dietician	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Norwegian food-based dietary guidelines	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.	3 months
Adherence to Norwegian food-based dietary guidelines	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.	6 months
Changes in physical activity levels	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)	baseline, 3 months
Changes in physical activity levels	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)	baseline, 6 months
Changes in body weight	Changes in body weight measured in kilograms	Baseline, 3 months
Changes in body weight	Changes in body weight measured in kilograms	Baseline, 6 months
Changes in blood pressure	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)	Baseline, 3 months
Changes in blood pressure	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)	Baseline, 6 months
Changes in total cholesterol	Changes in total cholesterol measured in mmol/l in non fasting blood samples	Baseline, 3 months
Changes in total cholesterol	Changes in total cholesterol measured in mmol/l in non fasting blood samples	Baseline, 6 months
Changes in HbA1c	Changes in HbA1c measured in mmol/l in non fasting blood samples	Baseline, 3 months
Changes in HbA1c	Changes in HbA1c measured in mmol/l in non fasting blood samples	Baseline, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction	Participants will complete qualitative surveys and participate in semi-structured interviews to measure their satisfaction with the intervention program.	9 months

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Harvard Medical School (HMS and HSDM); University of Oslo; St. Olavs Hospital; Helse Nord-Trøndelag HF
• Investigators: Study Director: Siri Forsmo, md prof, Norwegian University of Science and Technology NTNU

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 7, 2020
• Primary Completion (ACTUAL): May 4, 2021
• Study Completion (ACTUAL): May 4, 2021

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (ACTUAL): June 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Mentoring; Postpartum Period; Healthy life style
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Hypertension, Pregnancy-Induced; Diabetes Mellitus; Eclampsia; Pre-Eclampsia; Diabetes, Gestational
• Other Study ID Numbers: 2018/1803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No