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Hypertension in PregnancyENHANCE-CVHNCT06773299

Enhancing Intergenerational Health in Nigeria: Peripartum as Critical Life Stage for Cardiovascular Health

A study testing PAT+HEALTH curriculum - Nigeria in people with Hypertension in Pregnancy and Hypertension, run by Washington University School of Medicine at 1 site in Nigeria.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of the ENHANCE-CVH study is to promote intergenerational cardiovascular health (CVH) of women and children in Abuja and the surrounding Federal Capital Territory of Nigeria. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
PAT+HEALTH curriculum - Nigeria
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteNigeria
Study dates
23 Jun 2025to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • •≥18 years of age,
  • Pregnant women under 14 weeks gestation,
  • Singleton gestation,
  • Body mass index > 30 kg/m2
  • Willing to participate in ENHANCE CVH for 2 years,
  • Planning to receive prenatal care and deliver at either one of the participating primary healthcare, centers or University of Abuja Teaching Hospital, and
  • Able to give informed consent for study participation, understanding she and her child will both be involved.

Who cannot join

  • Current enrollment in a weight loss program,
  • Inability to engage in a walking program,
  • Active substance abuse
  • Treatment with medications known to impact weight (e.g., corticosteroids, antipsychotics),
  • Plan to relocate within the next 2 years, or
  • Unwilling to provide informed consent.

Trial locations and contacts

1 site in 1 country.

Nigeria1 site
  • University of Abuja Teaching Hospital

    Abuja

Other trials in Nigeria

About this study

Official title: ENhancing Intergenerational HeAlth in Nigeria: Peripartum as Critical Life StagE for CardioVascular Health

The purpose of the ENHANCE-CVH study is to promote intergenerational cardiovascular health (CVH) of women and children in Abuja and the surrounding Federal Capital Territory of Nigeria. The study team plans to achieve this through an adaptation of an existing evidence based intervention - Parents as Teachers (PAT) curriculum + Healthy Eating Active Living Taught at Home (HEALTH) - among pregnant women with obesity and their children in Nigeria. The aim of the study is to evaluate the effectiveness and implementation of community health educator-led delivery of the PAT+HEALTH intervention via home visits to answer the following main questions:

  • Will the women participating in the intervention have a greater change in weight from baseline to 18-month follow up compared to the women who do not?
  • Will the women and children in the intervention group display better CVH promoting lifestyle behaviors compared to those in the control group?

Participants in the study will complete baseline surveys and have clinical data, lab data, and body measurements captured. Participants will also have these procedures repeated at birth and every 6 months up to 24 months post-delivery. Once randomized to the intervention group, participants will complete 40 biweekly PAT+HEALTH curriculum delivery sessions, each lasting approximately 60-90 minutes.

Being tested
PAT+HEALTH curriculum - Nigeria
Keywords
Maternal Hypertension, Maternal and infant cardiovascular health, Hybrid Type 2 effectiveness-implementation, Obesity in pregnancy
Medical subject headings
Hypertension, Pregnancy-Induced, Hypertension, Obesity, Overweight, Pregnancy in Obesity

What participants receive

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

  • PAT+HEALTH curriculum - NigeriaBehavioural

    This intervention is an adaption of the PAT Curriculum and the HEALTH intervention specifically tailored for the Nigerian context.

Study groups in NCT06773299
Study groupRoleWhat they receive
PAT+HEALTH InterventionExperimentalParticipants randomized to this arm will receive 40 biweekly PAT+HEALTH intervention delivery ante- and postnatally. These will primarily focus on promoting cardiovascular health for mother and child through lifestyle and behavioral modifications along with additional support and education for pregnancy and cardiovascular health.
Receives: Behavioral: PAT+HEALTH curriculum - Nigeria
ControlNo interventionParticipants randomized to the control group will not receive the PAT+HEALTH intervention and will only receive standard ante- and postnatal care.

What is being measured

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

  1. Change in maternal body weight from baseline

    Between group difference in change in maternal body weight f rom baseline to 18-month follow-up measured in kilograms.

    Measured: Baseline to 18-month postnatal follow up

Secondary outcomes (17)
  1. Change in cardiovascular health score

    Between group difference in change in maternal cardiovascular health score (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.

    Measured: Baseline to 18-month postnatal follow up

  2. Change in cardiovascular health score - Tobacco Use/Exposure

    Between group difference in change in Tobacco Use/exposure subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.

    Measured: Baseline to 18-month postnatal follow up

  3. Change in cardiovascular health score - Diet

    Between group difference in change in Diet subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.

    Measured: Baseline to 18-month postnatal follow up

  4. Change in cardiovascular health score - Physical Activity

    Between group difference in change in Physical Activity subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.

    Measured: Baseline to 18-month postnatal follow up

  5. Change in cardiovascular health score - BMI

    Between group difference in change in BMI subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.

    Measured: Baseline to 18-month postnatal follow up

  6. Change in cardiovascular health score - Blood Pressure

    Between group difference in change in blood pressure subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.

    Measured: Baseline to 18-month postnatal follow up

  7. Change in cardiovascular health score - Cholesterol

    Between group difference in change in cholesterol subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.

    Measured: Baseline to 18-month postnatal follow up

  8. Change in cardiovascular health score - Blood Sugar

    Between group difference in change in Blood Sugar subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.

    Measured: Baseline to 18-month postnatal follow up

  9. Change in cardiovascular health score - Sleep

    Between group difference in change in Sleep subscore (range from 0-100: Life's Essential 8) from baseline to 18-month postnatal follow-up.

    Measured: Baseline to 18-month postnatal follow up

  10. Change in Child CVH behaviors - Diet

    Between group difference in child cardiovascular health behaviors as measured through parent-reported diet from birth to 18 months.

    Measured: Birth to 18 months

  11. Change in Child CVH behaviors - Physical Activity

    Between group difference in child cardiovascular health behaviors as measured through parent-reported activity from birth to 18 months using the Movement Behavior Questionnaire - Child Open Version (MBQ-C)

    Measured: Birth to 18 months

  12. Change in Child CVH behaviors - Sleep

    Between group difference in child cardiovascular health behaviors as measured through parent-reported sleep from birth to 18 months using the Brief Infant Sleep Questionnaire - Revised version (BISQ-R)

    Measured: Birth to 18 months

  13. Maternal Mortality

    Between group difference in composite rate of maternal mortality from baseline to 18 months postnatal follow-up

    Measured: Baseline to 18-month postnatal follow up

  14. Maternal morbidity

    Between group difference in composite rate of maternal morbidity (defined as occurrence of any serious adverse event) from baseline to 18 month postnatal follow-up.

    Measured: Baseline to 18-month postnatal follow up

  15. Stillbirth or spontaneous abortion

    Between group difference in the composite rate of stillbirth or spontaneous abortion.

    Measured: Measured at Birth

  16. Neonatal, infant, and child mortality

    Between group difference in the composite rate of neonatal, infant, or childhood mortality from birth to 18 months.

    Measured: Birth to 18 months

  17. Neonatal, infant, and child morbidity

    Between group difference in the composite rate of neonatal, infant, or childhood morbidity as defined by occurrence of any serious adverse events from birth to 18 months.

    Measured: Birth to 18 months

Timeline

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

  1. First posted14 Jan 2025
  2. Study start23 Jun 2025
  3. Primary completionOct 2027 (estimated)
  4. Study completionAug 2028 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06773299
Sponsor's protocol ID
R01HL168771
Acronym
ENHANCE-CVH
Status last verified
Jul 2026
First submitted
16 Dec 2024
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be made available after the conclusion of the study following the guidelines of BioData Catalyst. A codebook will be provided.

Publications

  • GBD 2019 Demographics Collaborators. Global age-sex-specific fertility, mortality, healthy life expectancy (HALE), and population estimates in 204 countries and territories, 1950-2019: a comprehensive demographic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1160-1203. doi: 10.1016/S0140-6736(20)30977-6.

    PubMed 33069325
  • Tukur J, Lavin T, Adanikin A, Abdussalam M, Bankole K, Ekott MI, Godwin A, Ibrahim HA, Ikechukwu O, Kadas SA, Nwokeji-Onwe L, Nzeribe E, Ogunkunle TO, Oyeneyin L, Tunau KA, Bello M, Aminu I, Ezekwe B, Aboyeji P, Adesina OA, Chama C, Etuk S, Galadanci H, Ikechebelu J, Oladapo OT; Maternal and Perinatal Database for Quality, Equity and Dignity Network. Quality and outcomes of maternal and perinatal care for 76,563 pregnancies reported in a nationwide network of Nigerian referral-level hospitals. EClinicalMedicine. 2022 Apr 28;47:101411. doi: 10.1016/j.eclinm.2022.101411. eCollection 2022 May.

    PubMed 35518118
  • Abubakar I, Dalglish SL, Angell B, Sanuade O, Abimbola S, Adamu AL, Adetifa IMO, Colbourn T, Ogunlesi AO, Onwujekwe O, Owoaje ET, Okeke IN, Adeyemo A, Aliyu G, Aliyu MH, Aliyu SH, Ameh EA, Archibong B, Ezeh A, Gadanya MA, Ihekweazu C, Ihekweazu V, Iliyasu Z, Kwaku Chiroma A, Mabayoje DA, Nasir Sambo M, Obaro S, Yinka-Ogunleye A, Okonofua F, Oni T, Onyimadu O, Pate MA, Salako BL, Shuaib F, Tsiga-Ahmed F, Zanna FH. The Lancet Nigeria Commission: investing in health and the future of the nation. Lancet. 2022 Mar 19;399(10330):1155-1200. doi: 10.1016/S0140-6736(21)02488-0. Epub 2022 Mar 15. No abstract available.

    PubMed 35303470
  • Parikh NI, Gonzalez JM, Anderson CAM, Judd SE, Rexrode KM, Hlatky MA, Gunderson EP, Stuart JJ, Vaidya D; American Heart Association Council on Epidemiology and Prevention; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; and the Stroke Council. Adverse Pregnancy Outcomes and Cardiovascular Disease Risk: Unique Opportunities for Cardiovascular Disease Prevention in Women: A Scientific Statement From the American Heart Association. Circulation. 2021 May 4;143(18):e902-e916. doi: 10.1161/CIR.0000000000000961. Epub 2021 Mar 29.

    PubMed 33779213
  • Nigeria Federal Ministry of Health (2019). National Multi-Sectoral Action Plan for the Prevention and Control of Non-Communicable Diseases; Federal Capital Territory, Nigeria.

  • Aifah A, Onakomaiya D, Iwelunmor J, Oladele D, Gbajabiamila T, Obiezu-Umeh C, Nwaozuru U, Musa AZ, Ezechi O, Ogedegbe G. Nurses' perceptions on implementing a task-shifting/sharing strategy for hypertension management in patients with HIV in Nigeria: a group concept mapping study. Implement Sci Commun. 2020 Jun 26;1:58. doi: 10.1186/s43058-020-00048-y. eCollection 2020.

    PubMed 32885213
  • Wiltsey Stirman S, Baumann AA, Miller CJ. The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions. Implement Sci. 2019 Jun 6;14(1):58. doi: 10.1186/s13012-019-0898-y.

    PubMed 31171014
  • Haire-Joshu D, Schwarz CD, Steger-May K, Lapka C, Schechtman K, Brownson RC, Tabak RG. A Randomized Trial of Weight Change in a National Home Visiting Program. Am J Prev Med. 2018 Mar;54(3):341-351. doi: 10.1016/j.amepre.2017.12.012.

    PubMed 29455756
  • Haire-Joshu D, Cahill AG, Stein RI, Cade WT, Woolfolk CL, Moley K, Mathur A, Schwarz CD, Schechtman KB, Klein S. Randomized Controlled Trial of Home-Based Lifestyle Therapy on Postpartum Weight in Underserved Women with Overweight or Obesity. Obesity (Silver Spring). 2019 Apr;27(4):535-541. doi: 10.1002/oby.22413.

    PubMed 30900408
  • Cahill AG, Haire-Joshu D, Cade WT, Stein RI, Woolfolk CL, Moley K, Mathur A, Schechtman K, Klein S. Weight Control Program and Gestational Weight Gain in Disadvantaged Women with Overweight or Obesity: A Randomized Clinical Trial. Obesity (Silver Spring). 2018 Mar;26(3):485-491. doi: 10.1002/oby.22070.

    PubMed 29464907
  • Ojji DB, Baldridge AS, Orji IA, Shedul GL, Ojo TM, Ye J, Chopra A, Ale BM, Shedul G, Ugwuneji EN, Egenti NB, Aluka-Omitiran K, Okoli RCB, Eze H, Nwankwo A, Banigbe B, Tripathi P, Kandula NR, Hirschhorn LR, Huffman MD; Hypertension Treatment in Nigeria Program Investigators. Characteristics, treatment, and control of hypertension in public primary healthcare centers in Nigeria: baseline results from the Hypertension Treatment in Nigeria Program. J Hypertens. 2022 May 1;40(5):888-896. doi: 10.1097/HJH.0000000000003089. Epub 2022 Jan 15.

    PubMed 35034080
  • Glasgow RE, Battaglia C, McCreight M, Ayele RA, Rabin BA. Making Implementation Science More Rapid: Use of the RE-AIM Framework for Mid-Course Adaptations Across Five Health Services Research Projects in the Veterans Health Administration. Front Public Health. 2020 May 27;8:194. doi: 10.3389/fpubh.2020.00194. eCollection 2020.

    PubMed 32528921
  • Gemechu KS, Assefa N, Mengistie B. Prevalence of hypertensive disorders of pregnancy and pregnancy outcomes in Sub-Saharan Africa: A systematic review and meta-analysis. Womens Health (Lond). 2020 Jan-Dec;16:1745506520973105. doi: 10.1177/1745506520973105.

    PubMed 33334273
  • Adeloye D, Ige-Elegbede JO, Ezejimofor M, Owolabi EO, Ezeigwe N, Omoyele C, Mpazanje RG, Dewan MT, Agogo E, Gadanya MA, Alemu W, Harhay MO, Auta A, Adebiyi AO. Estimating the prevalence of overweight and obesity in Nigeria in 2020: a systematic review and meta-analysis. Ann Med. 2021 Dec;53(1):495-507. doi: 10.1080/07853890.2021.1897665.

    PubMed 33783281
  • Institute of Medicine (US) and National Research Council (US) Committee to Reexamine IOM Pregnancy Weight Guidelines; Rasmussen KM, Yaktine AL, editors. Weight Gain During Pregnancy: Reexamining the Guidelines. Washington (DC): National Academies Press (US); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK32813/

    PubMed 20669500

Questions about this trial

What is this clinical trial studying?

A study testing PAT+HEALTH curriculum - Nigeria in people with Hypertension in Pregnancy and Hypertension, run by Washington University School of Medicine at 1 site in Nigeria.

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 7 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. 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 Nigeria. 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?

This study is still under way. Results are not available in the source record yet.

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?

Change in maternal body weight from baseline (time frame: Baseline to 18-month postnatal follow up). 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 NCT06773299, which also lists 66 linked publications.

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 24 Jul 2026.

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