Pre-EclampsiaNCT03993145
Lifestyle Intervention for Women With Recent Pre-eclampsia or Gestational Diabetes Mellitus ('Mom's Healthy Heart')
A study testing Web-based lifestyle intervention in people with Pre-Eclampsia and Gestational Diabetes, run by Norwegian University of Science and Technology at 2 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia, Gestational Diabetes
- What is being tested?
- Web-based lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesNorway
- Study dates
- 7 Feb 2020to 4 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Pre-Eclampsia, Gestational Diabetes
- Being tested
- Web-based lifestyle intervention
- Keywords
- Mentoring, Healthy life style, Postpartum Period
- Medical subject headings
- Pre-Eclampsia, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based lifestyle interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Web-based lifestyle intervention | Experimental | participants will be provided access to web-based lifestyle intervention program with personalized coaching from a clinical dietician Receives: Behavioral: Web-based lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Proportion of eligible patients enrolled in the study
Measured: baseline
Retention
Proportion of participants kept in the study
Measured: 3 months
Retention
Proportion of participants kept in the study
Measured: 6 months
Adherence
Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)
Measured: 3 months
Adherence
Proportion of participants following study program (visiting the study's website and having scheduled phone conversations with the dietician)
Measured: 6 months
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: baseline, 6 months
Changes in body weight
Changes in body weight measured in kilograms
Measured: Baseline, 3 months
Changes in body weight
Changes in body weight measured in kilograms
Measured: 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)
Measured: 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)
Measured: Baseline, 6 months
Changes in total cholesterol
Changes in total cholesterol measured in mmol/l in non fasting blood samples
Measured: Baseline, 3 months
Changes in total cholesterol
Changes in total cholesterol measured in mmol/l in non fasting blood samples
Measured: Baseline, 6 months
Changes in HbA1c
Changes in HbA1c measured in mmol/l in non fasting blood samples
Measured: Baseline, 3 months
Changes in HbA1c
Changes in HbA1c measured in mmol/l in non fasting blood samples
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start7 Feb 2020
- Primary completion4 May 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), University of Oslo, Helse Nord-Trøndelag HF, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Siri Forsmo, md prof, Study director, Norwegian University of Science and Technology NTNU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993145
- Sponsor's protocol ID
- 2018/1803
- Status last verified
- May 2021
- First submitted
- 18 Jun 2019
- Last updated
- 12 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37485436
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention for Women With Recent Pre-eclampsia or Gestational Diabetes Mellitus: A Pilot Intervention Study
- ClinicalTrials.gov ID
- NCT03993145
- Acronym / sponsor ID
- 2018/1803
- Conditions
- Pre-Eclampsia, Gestational Diabetes
- Keywords
- Mentoring, Healthy life style, Postpartum Period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), University of Oslo, Helse Nord-Trøndelag HF, St. Olavs Hospital
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-based lifestyle intervention | Experimental | Behavioral: Web-based lifestyle interventionparticipants will be provided access to web-based lifestyle intervention program with personalized coaching from a clinical dietician |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based lifestyle interventionLifestyle 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). | Behavioural | Web-based lifestyle intervention |
Primary outcome
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)
12 secondary outcomes
Adherence to Norwegian food-based dietary guidelines
Time frame: 3 months
Adherence to Norwegian food-based dietary guidelines
Time frame: 6 months
Changes in physical activity levels
Time frame: baseline, 3 months
Changes in physical activity levels
Time frame: baseline, 6 months
Changes in body weight
Time frame: Baseline, 3 months
Changes in body weight
Time frame: Baseline, 6 months
Changes in blood pressure
Time frame: Baseline, 3 months
Changes in blood pressure
Time frame: Baseline, 6 months
Changes in total cholesterol
Time frame: Baseline, 3 months
Changes in total cholesterol
Time frame: Baseline, 6 months
Changes in HbA1c
Time frame: Baseline, 3 months
Changes in HbA1c
Time frame: Baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Derived from this study: PubMed 37485436Horn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siri Forsmo, md prof study director
Norwegian University of Science and Technology NTNU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based lifestyle intervention in people with Pre-Eclampsia and Gestational Diabetes, run by Norwegian University of Science and Technology at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03993145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.