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Hypertension in PregnancyNCT04998942

Virtual Cardiac Wellness Program Following Hypertensive Disorders of Pregnancy

A study testing virtual cardiac wellness program in people with Hypertension in Pregnancy and Gestational Hypertension, run by Massachusetts General Hospital at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hypertensive disorders of pregnancy (HDP) are now well-recognized risk factors for adverse outcomes in the postpartum period and for development of future cardiovascular disease (CVD). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
virtual cardiac wellness program
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited States
Study dates
11 Aug 2021to Jun 2023
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

  • Women with a diagnosis of HDP inclusive of gestational hypertension, preeclampsia, eclampsia, and chronic hypertension with superimposed preeclampsia
  • Pre-pregnancy BMI >18.5
  • Age ≥ 18 years
  • Access to a phone
  • Delivery at MGH and receive longitudinal obstetrics care at MGH

Who cannot join

  • Moderate or severe cognitive impairment
  • Current incarceration
  • Pre-pregnancy BMI ≤ 18.5
  • Women without a documented pre-natal weight or weight recorded 1 year prior to pregnancy
  • Baseline exercise of > 150 minutes/ week at the time of study enrollment
  • Not cleared for exercise by primary OB

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Hypertensive disorders of pregnancy (HDP) are now well-recognized risk factors for adverse outcomes in the postpartum period and for development of future cardiovascular disease (CVD). Postpartum BMI has emerged as a strong predictor of both short- and long-term blood pressure (BP) control in observational studies suggesting that earlier postpartum lifestyle modifications may be instrumental in future CVD risk reduction in women with HDP. While such lifestyle modifications are recognized as critical for postpartum health, implementation and engagement of postpartum women remains a challenge as new mothers face greater barriers to in-person care given childcare responsibilities. The proposed study will investigate the acceptability of a virtual cardiac wellness program and its impact on weight, lifestyle modifications, cardiometabolic health, patient engagement, and outcomes following HDP as compared to the standard of care for postpartum women at Massachusetts General Hospital.

Being tested
virtual cardiac wellness program, Placebo comparator
Medical subject headings
Hypertension, Pregnancy-Induced, Pre-Eclampsia, Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • virtual cardiac wellness programBehavioural

    Participants assigned to this arm will participate in the experimental intervention.

  • Placebo comparatorBehavioural

    Participants assigned to this arm will participate in a placebo intervention.

Study groups in NCT04998942
Study groupRoleWhat they receive
ExperimentalExperimentalNot described
Receives: Behavioral: virtual cardiac wellness program
Placebo comparatorPlacebo comparatorNot described
Receives: Behavioral: Placebo comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postpartum weight loss at 6 months postpartum

    Postpartum weight loss (Last prenatal visit weight- weight at 6 months postpartum) as a proportion of weight gained during pregnancy (Last prenatal visit weight- either 1st prenatal weight or pre-pregnancy weight within 1 year)

    Measured: 1 year

Secondary outcomes (14)

  1. Postpartum weight loss at 1 year postpartum

    Postpartum weight loss (from last prenatal visit weight) at 1 year postpartum as a proportion of weight gained during pregnancy

    Measured: 1 year

  2. Return to pre-pregnancy weight

    Proportion of women who return to pre-pregnancy weight at 6 months postpartum

    Measured: 6 months

  3. Return to pre-pregnancy weight

    Proportion of women who return to pre-pregnancy weight at 1 year postpartum

    Measured: 1 year

  4. Changes in blood pressure

    Systolic and diastolic blood pressure at 6 months postpartum

    Measured: 6 months

  5. Changes in blood pressure

    Systolic and diastolic blood pressure at 1 year postpartum

    Measured: 1 year

  6. Change in sedentary time

    Change in self-reported sedentary time from study enrollment and study completion (completion of the study intervention). Decreased sedentary time means better outcomes.

    Measured: 6 months

  7. Change in physical activity as assessed by self-reported physical activity survey

    Change in self-reported physical activity from study enrollment and study completion as assessed by self-reported physical activity survey (Days per week exercised, length of exercise sessions). Increased physical activity means a better outcome.

    Measured: 6 months

  8. Change in physical activity as assessed by modified Duke Activity Status Index

    Change in self-reported physical activity from study enrollment and study completion as assessed by modified Duke Activity Status Index (6 question yes/no survey, score ranges from 0-31.5). A higher score means a higher functional status.

    Measured: 6 months

  9. Change in stress as assessed by self-reported stress survey

    Change in self-reported stress from study enrollment and study completion as assessed by self-reported stress survey (3 questions on scale of 0-4 [0= Never experience stress, 4= Constant stress], Max score=12). A lower score means a better outcome.

    Measured: 6 months

  10. Change in stress as assessed by American Heart Association Cardiovascular Disease Go Red Questionnaire

    Change in self-reported stress from study enrollment and study completion as assessed by American Heart Association Cardiovascular Disease Go Red Questionnaire (11 questions on scale of 0-4 [0= None of the Time, 4= All of the Time], Max score=44). A lower score means a better outcome.

    Measured: 6 months

  11. Change in self efficacy for diet

    Change in self efficacy to eat a healthy diet from study enrollment and study completion assessed by an 8-question survey rating confidence for motivating oneself to do tasks relating to eating healthy consistently for at least 6 months (Range 1 [I could not do it] to 5 [I could do it], Max score= 40). A higher score means a better outcome.

    Measured: 6 months

  12. Change in self efficacy for physical activity assessed by questionnaire

    Change in self efficacy toward achieving and maintaining a healthy level of physical activity assessed by an 8-question survey rating confidence for motivating oneself to do tasks related to physical activity consistently for at least 6 months (Range 1 [I could not do it] to 5 [I could do it], Max score= 40). A higher score means a better outcome.

    Measured: 6 months

  13. Change in cardiovascular disease knowledge assessed by American Heart Association Cardiovascular Disease Go Red Questionnaire

    Change in knowledge on the American Heart Association Cardiovascular Disease Go Red Questionnaire (modified for the postpartum population) from study enrollment and study completion (5 questions total: 4 questions on scale of 0-4 [0= Very well informed, 4= Not at all informed], Max score=16, 16-part question about the causes of heart disease [1= Yes, 2 =No], Max score = 32). A lower score means a better outcome.

    Measured: 6 months

  14. Change in quality of diet assessed by Dietary Approaches to Stop Hypertension (DASH) score

    Change in quality of diet assessed by Dietary Approaches to Stop Hypertension (DASH) score from study enrollment and study completion (DASH score range 0 [no targets met] to 9 [all targets met]). A higher score means a better outcome.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2021
  2. Study start11 Aug 2021
  3. Primary completion13 Mar 2023
  4. Study completionJun 2023 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
In this study, we are testing different strategies to help women keep their heart healthy after a pregnancy complicated by hypertension. Participants may or may not undergo some of the following study procedures: * Complete surveys which could include topics related to activity, stress, nutrition, heart disease etc. with study staff via telephone or a secure online platform * Be contacted by study staff once monthly to collect subjects' weight, blood pressure, whether they are breastfeeding, exercise routine, smoking status, and stress levels * Meet with a nutritionist * Meet with an exercise physiologist * Participate in optional group sessions * Receive infographics which could include topics such as mindful living and lifestyle, prevention of heart disease, nutrition, heart disease, etc. Arm assignment and a description of the arms will be disclosed to participants after study completion.
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04998942
Sponsor's protocol ID
2021P001285
Status last verified
May 2023
First submitted
12 Jul 2021
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing virtual cardiac wellness program in people with Hypertension in Pregnancy and Gestational Hypertension, run by Massachusetts General Hospital at 1 site in United States.

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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

Postpartum weight loss at 6 months postpartum (time frame: 1 year). 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 NCT04998942.

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 10 May 2023.

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