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| Name | Class |
|---|---|
| University of Abuja Teaching Hospital | OTHER |
| New York University | OTHER |
| Parents as Teachers | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAT+HEALTH Intervention | Experimental | Participants 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. |
|
| Control | No Intervention | Participants randomized to the control group will not receive the PAT+HEALTH intervention and will only receive standard ante- and postnatal care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PAT+HEALTH curriculum - Nigeria | Behavioral | This intervention is an adaption of the PAT Curriculum and the HEALTH intervention specifically tailored for the Nigerian context. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 18-month postnatal follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 18-month postnatal follow up |
| Change in cardiovascular health score - Tobacco Use/Exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Child Weight for length | Between group difference in child weight-for-length z-score at 6 and 18 months, adjusted for weight-for-length z-score at birth. | Birth, 6 months, 18 months |
| Child BMI | Between group difference in child BMI z-score at 6 and 18 months, adjusted for weight-for-length z-score at birth. |
Inclusion Criteria:
•≥18 years of age,
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark D Huffman, MD, MPH | Contact | 314-362-1291 | m.huffman@wustl.edu | |
| Guhan R Iyer, MPH | Contact | 314-362-1291 | guhaniyer@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dike B Ojji, MD | University of Abuja Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Abuja Teaching Hospital | Recruiting | Abuja | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33069325 | Background | 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. | |
| 35518118 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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De-identified data will be made available after the conclusion of the study following the guidelines of BioData Catalyst. A codebook will be provided.
Beginning not later than 6 months after publication of results with no end date.
Those who have privileges to access data stored within the BioData Catalyst repository may access the data as per the rules and regulations of that system. Data provided to BioData Catalyst will be completely de-identified following their criteria.
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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. |
| Baseline to 18-month postnatal follow up |
| 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. | Baseline to 18-month postnatal follow up |
| 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. | Baseline to 18-month postnatal follow up |
| 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. | Baseline to 18-month postnatal follow up |
| 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. | Baseline to 18-month postnatal follow up |
| 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. | Baseline to 18-month postnatal follow up |
| 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. | Baseline to 18-month postnatal follow up |
| 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. | Baseline to 18-month postnatal follow up |
| 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. | Birth to 18 months |
| 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) | Birth to 18 months |
| 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) | Birth to 18 months |
| Maternal Mortality | Between group difference in composite rate of maternal mortality from baseline to 18 months postnatal follow-up | Baseline to 18-month postnatal follow up |
| 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. | Baseline to 18-month postnatal follow up |
| Stillbirth or spontaneous abortion | Between group difference in the composite rate of stillbirth or spontaneous abortion. | Measured at Birth |
| Neonatal, infant, and child mortality | Between group difference in the composite rate of neonatal, infant, or childhood mortality from birth to 18 months. | Birth to 18 months |
| 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. | Birth to 18 months |
| Birth, 6 months, 18 months |
| Parental feeding behaviors | Parental feeding behaviors measured by the Feeding to Manage Child Behavior Questionnaire (FMCBQ) | 6 months, 12 months, 18 months, 24 months |
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| 24438712 | Background | Sullivan SD, Mauskopf JA, Augustovski F, Jaime Caro J, Lee KM, Minchin M, Orlewska E, Penna P, Rodriguez Barrios JM, Shau WY. Budget impact analysis-principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health. 2014 Jan-Feb;17(1):5-14. doi: 10.1016/j.jval.2013.08.2291. Epub 2013 Dec 13. |
| 24456644 | Background | Calhoun A, Mainor A, Moreland-Russell S, Maier RC, Brossart L, Luke DA. Using the Program Sustainability Assessment Tool to assess and plan for sustainability. Prev Chronic Dis. 2014 Jan 23;11:130185. doi: 10.5888/pcd11.130185. |
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| 41345984 | Derived | Lopez JD, Aifah A, Nartey C, Ripiye NR, Shedul GL, Okpetu E, Nwaozuru UC, Aluka-Omitiran K, Onwu N, Obiezu-Umeh C, Marshall T, Kemner A, Lindley KJ, Haire-Joshu D, Davila-Roman VG, Akaba G, Huffman MD, Ojji DB, Okoro CE; ENHANCE C. V. H. Investigators. Enhancing intergenerational HeAlth in Nigeria: peripartum as Critical life stagE for CardioVascular Health (ENHANCE-CVH) study: findings from pre-implementation using the updated consolidated framework for implementation research (CFIR 2.0). Implement Sci Commun. 2025 Dec 4;7(1):5. doi: 10.1186/s43058-025-00816-8. |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D006973 | Hypertension |
| D009765 | Obesity |
| D050177 | Overweight |
| D000079262 | Pregnancy in Obesity |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided