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

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03993145
• Other study ID #: 2018/1803
• Status: Completed
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: May 4, 2021

Study information

• Verified date: May 2021
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 4, 2021
• Est. primary completion date: May 4, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Eclampsia
• Gestational Diabetes
• Pre-Eclampsia

Intervention

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).

Locations

Country	Name	City	State
Norway	Levanger sykehus	Levanger
Norway	St Olavs Hospital	Trondheim

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Harvard Medical School, Levanger Hospital, St. Olavs Hospital, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant satisfaction	Participants will complete qualitative surveys and participate in semi-structured interviews to measure their satisfaction with the intervention program.	9 months
Primary	Recruitment	Proportion of eligible patients enrolled in the study	baseline
Primary	Retention	Proportion of participants kept in the study	3 months
Primary	Retention	Proportion of participants kept in the study	6 months
Primary	Adherence	Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)	3 months
Primary	Adherence	Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Changes in body weight	Changes in body weight measured in kilograms	Baseline, 3 months
Secondary	Changes in body weight	Changes in body weight measured in kilograms	Baseline, 6 months
Secondary	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
Secondary	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
Secondary	Changes in total cholesterol	Changes in total cholesterol measured in mmol/l in non fasting blood samples	Baseline, 3 months
Secondary	Changes in total cholesterol	Changes in total cholesterol measured in mmol/l in non fasting blood samples	Baseline, 6 months
Secondary	Changes in HbA1c	Changes in HbA1c measured in mmol/l in non fasting blood samples	Baseline, 3 months
Secondary	Changes in HbA1c	Changes in HbA1c measured in mmol/l in non fasting blood samples	Baseline, 6 months