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

NCT06773299 | Recruiting DMC

• 1 other identifier: R01HL168771
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypertension in Pregnancy; Hypertension; Obesity and Overweight; Maternal Morbidity and Mortality; Maternal and Child Health Outcomes

Keywords

Maternal Hypertension; Maternal and infant cardiovascular health; Hybrid Type 2 effectiveness-implementation; Obesity in pregnancy

Outcome Measures

Primary Outcomes (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.

  Baseline to 18-month postnatal follow up

Secondary Outcomes (17)

• Change in cardiovascular health score

  Baseline to 18-month postnatal follow up

• Change in cardiovascular health score - Tobacco Use/Exposure

  Baseline to 18-month postnatal follow up

• Change in cardiovascular health score - Diet

  Baseline to 18-month postnatal follow up

• Change in cardiovascular health score - Physical Activity

  Baseline to 18-month postnatal follow up

• Change in cardiovascular health score - BMI

  Baseline to 18-month postnatal follow up

Other Outcomes (3)

• Child Weight for length

  Birth, 6 months, 18 months

• Child BMI

  Birth, 6 months, 18 months

• Parental feeding behaviors

  6 months, 12 months, 18 months, 24 months

Study Arms (2)

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.

Behavioral: PAT+HEALTH curriculum - Nigeria

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.

Interventions

PAT+HEALTH curriculum - Nigeria BEHAVIORAL

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

PAT+HEALTH Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Abuja Teaching Hospital: collaborator
• New York University: collaborator
• Parents as Teachers: collaborator

Study Sites (1)

University of Abuja Teaching Hospital

Abuja, Nigeria

RECRUITING

Related Publications (66)

• 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.

  PMID: 33069325 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.

  PMID: 35518118 BACKGROUND

• 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.

  PMID: 35303470 BACKGROUND

• 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.

  PMID: 33779213 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 32885213 BACKGROUND

• 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.

  PMID: 31171014 BACKGROUND

• 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.

  PMID: 29455756 BACKGROUND

• 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.

  PMID: 30900408 BACKGROUND

• 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.

  PMID: 29464907 BACKGROUND

• 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.

  PMID: 35034080 BACKGROUND

• 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.

  PMID: 32528921 BACKGROUND

• 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.

  PMID: 33334273 BACKGROUND

• 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.

  PMID: 33783281 BACKGROUND

• 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/

  PMID: 20669500 BACKGROUND

• Teede HJ, Bailey C, Moran LJ, Bahri Khomami M, Enticott J, Ranasinha S, Rogozinska E, Skouteris H, Boyle JA, Thangaratinam S, Harrison CL. Association of Antenatal Diet and Physical Activity-Based Interventions With Gestational Weight Gain and Pregnancy Outcomes: A Systematic Review and Meta-analysis. JAMA Intern Med. 2022 Feb 1;182(2):106-114. doi: 10.1001/jamainternmed.2021.6373.

  PMID: 34928300 BACKGROUND

• Mandy M, Nyirenda M. Developmental Origins of Health and Disease: the relevance to developing nations. Int Health. 2018 Mar 1;10(2):66-70. doi: 10.1093/inthealth/ihy006.

  PMID: 29528398 BACKGROUND

• Barker DJ. Fetal origins of coronary heart disease. BMJ. 1995 Jul 15;311(6998):171-4. doi: 10.1136/bmj.311.6998.171.

  PMID: 7613432 BACKGROUND

• Jebasingh F, Thomas N. Barker Hypothesis and Hypertension. Front Public Health. 2022 Jan 21;9:767545. doi: 10.3389/fpubh.2021.767545. eCollection 2021.

  PMID: 35127619 BACKGROUND

• Bhargava SK, Sachdev HS, Fall CH, Osmond C, Lakshmy R, Barker DJ, Biswas SK, Ramji S, Prabhakaran D, Reddy KS. Relation of serial changes in childhood body-mass index to impaired glucose tolerance in young adulthood. N Engl J Med. 2004 Feb 26;350(9):865-75. doi: 10.1056/NEJMoa035698.

  PMID: 14985484 BACKGROUND

• Haire-Joshu D, Tabak R. Preventing Obesity Across Generations: Evidence for Early Life Intervention. Annu Rev Public Health. 2016;37:253-71. doi: 10.1146/annurev-publhealth-032315-021859.

  PMID: 26989828 BACKGROUND

• Khalil A, Huffman MD, Prabhakaran D, Osmond C, Fall CH, Tandon N, Lakshmy R, Prabhakaran P, Biswas SK, Ramji S, Sachdev HS, Bhargava SK; New Delhi Birth Cohort. Predictors of carotid intima-media thickness and carotid plaque in young Indian adults: the New Delhi birth cohort. Int J Cardiol. 2013 Aug 20;167(4):1322-8. doi: 10.1016/j.ijcard.2012.03.180. Epub 2012 Apr 25.

  PMID: 22537976 BACKGROUND

• Huffman MD, Khalil A, Osmond C, Fall CH, Tandon N, Lakshmy R, Ramji S, Gera T, Prabhakaran P, Dey Biswas SK, Reddy KS, Bhargava SK, Sachdev HS, Prabhakaran D; New Delhi Birth Cohort. Association between anthropometry, cardiometabolic risk factors, & early life factors & adult measures of endothelial function: Results from the New Delhi Birth Cohort. Indian J Med Res. 2015 Dec;142(6):690-8. doi: 10.4103/0971-5916.174559.

  PMID: 26831418 BACKGROUND

• Paul IM, Savage JS, Anzman-Frasca S, Marini ME, Beiler JS, Hess LB, Loken E, Birch LL. Effect of a Responsive Parenting Educational Intervention on Childhood Weight Outcomes at 3 Years of Age: The INSIGHT Randomized Clinical Trial. JAMA. 2018 Aug 7;320(5):461-468. doi: 10.1001/jama.2018.9432.

  PMID: 30088009 BACKGROUND

• Phelan S, Clifton RG, Haire-Joshu D, Redman LM, Van Horn L, Evans M, Joshipura K, Couch KA, Arteaga SS, Cahill AG, Drews KL, Franks PW, Gallagher D, Josefson JL, Klein S, Knowler WC, Martin CK, Peaceman AM, Thom EA, Wing RR, Yanovski SZ, Pi-Sunyer X; LIFE-Moms Research Group. One-year postpartum anthropometric outcomes in mothers and children in the LIFE-Moms lifestyle intervention clinical trials. Int J Obes (Lond). 2020 Jan;44(1):57-68. doi: 10.1038/s41366-019-0410-4. Epub 2019 Jul 10.

  PMID: 31292531 BACKGROUND

• Leunissen RW, Kerkhof GF, Stijnen T, Hokken-Koelega A. Timing and tempo of first-year rapid growth in relation to cardiovascular and metabolic risk profile in early adulthood. JAMA. 2009 Jun 3;301(21):2234-42. doi: 10.1001/jama.2009.761.

  PMID: 19491185 BACKGROUND

• Ong KK, Ahmed ML, Emmett PM, Preece MA, Dunger DB. Association between postnatal catch-up growth and obesity in childhood: prospective cohort study. BMJ. 2000 Apr 8;320(7240):967-71. doi: 10.1136/bmj.320.7240.967.

  PMID: 10753147 BACKGROUND

• Sirard JR, Pate RR. Physical activity assessment in children and adolescents. Sports Med. 2001;31(6):439-54. doi: 10.2165/00007256-200131060-00004.

  PMID: 11394563 BACKGROUND

• Tabak RG, Morshed AB, Schwarz CD, Haire-Joshu D. Weight gain prevention content delivered to mothers: Lessons from an intervention embedded in a community organization. Obes Sci Pract. 2019 Nov 18;5(6):540-547. doi: 10.1002/osp4.369. eCollection 2019 Dec.

  PMID: 31890244 BACKGROUND

• Cole TJ, Power C, Moore GE. Intergenerational obesity involves both the father and the mother. Am J Clin Nutr. 2008 May;87(5):1535-6; author reply 1536-7. doi: 10.1093/ajcn/87.5.1535. No abstract available.

  PMID: 18469281 BACKGROUND

• Sutherland G, Brown S, Yelland J. Applying a social disparities lens to obesity in pregnancy to inform efforts to intervene. Midwifery. 2013 Apr;29(4):338-43. doi: 10.1016/j.midw.2012.01.016. Epub 2012 Nov 9.

  PMID: 23146141 BACKGROUND

• Wen LM, Baur LA, Simpson JM, Rissel C, Wardle K, Flood VM. Effectiveness of home based early intervention on children's BMI at age 2: randomised controlled trial. BMJ. 2012 Jun 26;344:e3732. doi: 10.1136/bmj.e3732.

  PMID: 22735103 BACKGROUND

• Savage JS, Birch LL, Marini M, Anzman-Frasca S, Paul IM. Effect of the INSIGHT Responsive Parenting Intervention on Rapid Infant Weight Gain and Overweight Status at Age 1 Year: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):742-9. doi: 10.1001/jamapediatrics.2016.0445.

  PMID: 27271455 BACKGROUND

• Seidler AL, Hunter KE, Johnson BJ, Ekambareshwar M, Taki S, Mauch CE, Mihrshahi S, Askie L, Campbell KJ, Daniels L, Taylor RW, Wen LM, Byrne R, Lawrence J, Perlstein R, Wardle K, Golley RK. Understanding, comparing and learning from the four EPOCH early childhood obesity prevention interventions: A multi-methods study. Pediatr Obes. 2020 Nov;15(11):e12679. doi: 10.1111/ijpo.12679. Epub 2020 Jun 15.

  PMID: 32543054 BACKGROUND

• Phelan JC, Link BG, Tehranifar P. Social conditions as fundamental causes of health inequalities: theory, evidence, and policy implications. J Health Soc Behav. 2010;51 Suppl:S28-40. doi: 10.1177/0022146510383498.

  PMID: 20943581 BACKGROUND

• Solar O, Irwin A. (2010) A Conceptual Framework for Action on the Social Determinants of Health. Social Determinants of Health Discussion Paper 2 (Policy and Practice). Geneva, Switzerland.

  BACKGROUND

• National Population Commission (NPC) [Nigeria] and ICF. Nigeria Demographic and Health Survey (NDHS) 2018. Abuja, Nigeria, and Rockville, Maryland, USA: NPC and ICF.

  BACKGROUND

• Adepoju P. Nigeria's new law aims to provide health insurance to all. Lancet. 2022 Jun 4;399(10341):2092. doi: 10.1016/S0140-6736(22)01008-X. No abstract available.

  PMID: 35658984 BACKGROUND

• WHO Recommendations on Antenatal Care for a Positive Pregnancy Experience. Geneva: World Health Organization; 2016. Available from http://www.ncbi.nlm.nih.gov/books/NBK409108/

  PMID: 28079998 BACKGROUND

• Antenatal Care: An Orientation Package for Health Care Providers. (2017) Nigeria Federal Ministry of Health Guidelines. Federal Capital Territory, Nigeria.

  BACKGROUND

• Ojji DB, Baldridge AS, Orji AI, Shedul LG, Ojji OI, Egenti NB, Nwankwo AM, Huffman MD. Feasibility and effect of community health worker support and home monitoring for blood pressure control in Nigeria: a randomised pilot trial. Cardiovasc J Afr. 2020 May-Jun;31(3):213-215. doi: 10.5830/CVJA-2019-066.

  PMID: 32627803 BACKGROUND

• Baldridge AS, Aluka-Omitiran K, Orji IA, Shedul GL, Ojo TM, Eze H, Shedul G, Ugwuneji EN, Egenti NB, Okoli RCB, Ale BM, Nwankwo A, Osagie S, Ye J, Chopra A, Sanuade OA, Tripathi P, Kandula NR, Hirschhorn LR, Huffman MD, Ojji DB. Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial. Implement Sci Commun. 2022 Aug 2;3(1):84. doi: 10.1186/s43058-022-00328-9.

  PMID: 35918703 BACKGROUND

• Ojji D, Aifah A, Dulli L, Iwelunmor J; MAP-IT Study Team. Early stakeholder engagement lessons from managing hypertension among people living with human-immunodeficiency virus: an integrated model (MAP-IT). Eur Heart J. 2022 Jul 1;43(25):2347-2349. doi: 10.1093/eurheartj/ehac159. No abstract available.

  PMID: 35441679 BACKGROUND

• Ojji D; Nigeria Sodium Study Team. Developing long-term strategies to reduce excess salt consumption in Nigeria. Eur Heart J. 2022 Mar 31;43(13):1277-1279. doi: 10.1093/eurheartj/ehac025. No abstract available.

  PMID: 35134903 BACKGROUND

• Dietary Guidelines Advisory Committee. 2020. Scientific Report of the 2020 Dietary Guidelines Advisory Committee: Advisory Report to the Secretary of Agriculture and the Secretary of Health and Human Services. U.S. Department of Agriculture, Agricultural Research Service, Washington, DC. Available at: Https://Doi.Org/10.52570/DGAC2020.

  BACKGROUND

• Holtrop JS, Rabin BA, Glasgow RE. Qualitative approaches to use of the RE-AIM framework: rationale and methods. BMC Health Serv Res. 2018 Mar 13;18(1):177. doi: 10.1186/s12913-018-2938-8.

  PMID: 29534729 BACKGROUND

• Shelton RC, Chambers DA, Glasgow RE. An Extension of RE-AIM to Enhance Sustainability: Addressing Dynamic Context and Promoting Health Equity Over Time. Front Public Health. 2020 May 12;8:134. doi: 10.3389/fpubh.2020.00134. eCollection 2020.

  PMID: 32478025 BACKGROUND

• Gale RC, Wu J, Erhardt T, Bounthavong M, Reardon CM, Damschroder LJ, Midboe AM. Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans Health Administration. Implement Sci. 2019 Feb 1;14(1):11. doi: 10.1186/s13012-019-0853-y.

  PMID: 30709368 BACKGROUND

• Kirk MA, Moore JE, Wiltsey Stirman S, Birken SA. Towards a comprehensive model for understanding adaptations' impact: the model for adaptation design and impact (MADI). Implement Sci. 2020 Jul 20;15(1):56. doi: 10.1186/s13012-020-01021-y.

  PMID: 32690104 BACKGROUND

• Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.

  PMID: 17872937 BACKGROUND

• Orji IA, Baldridge AS, Omitiran K, Guo M, Ajisegiri WS, Ojo TM, Shedul G, Kandula NR, Hirschhorn LR, Huffman MD, Ojji DB. Capacity and site readiness for hypertension control program implementation in the Federal Capital Territory of Nigeria: a cross-sectional study. BMC Health Serv Res. 2021 Apr 9;21(1):322. doi: 10.1186/s12913-021-06320-8.

  PMID: 33836719 BACKGROUND

• Huffman MD, Capewell S, Ning H, Shay CM, Ford ES, Lloyd-Jones DM. Cardiovascular health behavior and health factor changes (1988-2008) and projections to 2020: results from the National Health and Nutrition Examination Surveys. Circulation. 2012 May 29;125(21):2595-602. doi: 10.1161/CIRCULATIONAHA.111.070722. Epub 2012 Apr 30.

  PMID: 22547667 BACKGROUND

• Riley L, Guthold R, Cowan M, Savin S, Bhatti L, Armstrong T, Bonita R. The World Health Organization STEPwise Approach to Noncommunicable Disease Risk-Factor Surveillance: Methods, Challenges, and Opportunities. Am J Public Health. 2016 Jan;106(1):74-8. doi: 10.2105/AJPH.2015.302962.

  PMID: 26696288 BACKGROUND

• Lloyd-Jones DM, Allen NB, Anderson CAM, Black T, Brewer LC, Foraker RE, Grandner MA, Lavretsky H, Perak AM, Sharma G, Rosamond W; American Heart Association. Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association. Circulation. 2022 Aug 2;146(5):e18-e43. doi: 10.1161/CIR.0000000000001078. Epub 2022 Jun 29.

  PMID: 35766027 BACKGROUND

• American Academy of Pediatrics. Bright Futures: Prevention and Health Promotion for Infants, Children, Adolescents, and Their Families. 2021; Https://Brightfutures.Aap.Org/Pages/Default.Aspx. Accessed July 25, 2022.

  BACKGROUND

• Kapp JM, Hall B, Kemner A. Collecting Early Childhood Obesity Measurements Through a Home Visiting Program: A Proof-of-Concept Study. Prev Chronic Dis. 2020 Dec 31;17:E169. doi: 10.5888/pcd17.200214.

  PMID: 33416469 BACKGROUND

• Skinner AC, Ravanbakht SN, Skelton JA, Perrin EM, Armstrong SC. Prevalence of Obesity and Severe Obesity in US Children, 1999-2016. Pediatrics. 2018 Mar;141(3):e20173459. doi: 10.1542/peds.2017-3459.

  PMID: 29483202 BACKGROUND

• O'Connor EA, Evans CV, Burda BU, Walsh ES, Eder M, Lozano P. Screening for Obesity and Intervention for Weight Management in Children and Adolescents: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2017 Jun 20;317(23):2427-2444. doi: 10.1001/jama.2017.0332.

  PMID: 28632873 BACKGROUND

• WHO Child Growth Standards. Int J Pediatrics. 2006; 95(S450): 1-106. doi: 10.1080/08035320500495373

  BACKGROUND

• Ebrahim GJ. WHO Child Growth Standards. Growth velocity based on weight, length and head circumference: methods and development. J Trop Pediatrics. 2010;56(2):136-136. doi:10.1093/tropej/fmp086

  BACKGROUND

• Hamilton CM, Strader LC, Pratt JG, Maiese D, Hendershot T, Kwok RK, Hammond JA, Huggins W, Jackman D, Pan H, Nettles DS, Beaty TH, Farrer LA, Kraft P, Marazita ML, Ordovas JM, Pato CN, Spitz MR, Wagener D, Williams M, Junkins HA, Harlan WR, Ramos EM, Haines J. The PhenX Toolkit: get the most from your measures. Am J Epidemiol. 2011 Aug 1;174(3):253-60. doi: 10.1093/aje/kwr193. Epub 2011 Jul 11.

  PMID: 21749974 BACKGROUND

• Thompson T, McQueen A, Croston M, Luke A, Caito N, Quinn K, Funaro J, Kreuter MW. Social Needs and Health-Related Outcomes Among Medicaid Beneficiaries. Health Educ Behav. 2019 Jun;46(3):436-444. doi: 10.1177/1090198118822724. Epub 2019 Jan 17.

  PMID: 30654655 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.

  PMID: 24438712 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.

  PMID: 24456644 BACKGROUND

• Luke DA, Calhoun A, Robichaux CB, Elliott MB, Moreland-Russell S. The Program Sustainability Assessment Tool: a new instrument for public health programs. Prev Chronic Dis. 2014 Jan 23;11:130184. doi: 10.5888/pcd11.130184.

  PMID: 24456645 BACKGROUND

• 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.

  PMID: 41345984 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension; Obesity; Overweight; Pregnancy in Obesity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dike B Ojji, MD

  University of Abuja Teaching Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark D Huffman, MD, MPH

CONTACT

314-362-1291; m.huffman@wustl.edu

Guhan R Iyer, MPH

CONTACT

314-362-1291; guhaniyer@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: January 14, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning not later than 6 months after publication of results with no end date.
• Access Criteria: 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.

Locations

NG (1)