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Effectiveness of Health Coaching to Reduce Cardiometabolic Risk in Early Home Visiting Services

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Qué se está evaluando

Healthy for Two-Health Coaching (H42)

+ Maintain Healthy in Pregnancy and Postpartum(mHIPP)

Conductual
Quiénes están siendo reclutados

Aumento de Peso Gestacional+6

+ Cambios en el Peso Corporal

+ Peso Corporal

A partir de 18 años
+15 Criterios de eligibilidad
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Cómo está diseñado el estudio

Estudio de Prevención

Intervencional
Inicio del estudio: abril de 2023
Ver detalles del protocolo

Resumen

Patrocinador PrincipalJohns Hopkins University
Contacto del EstudioKelly M Bower, PhD, MSN/MPHMás contactos
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 25 de abril de 2023

Fecha en la que se inscribió al primer participante.

There are four components of the H42-HV intervention: 1) Health coaching calls; 2) H42 web-based app for learning activities and goal setting functions; 3) Tracking of health behaviors (diet, exercise), and 4) Self-weighing (weekly). The overarching behavioral goals of the intervention are for participants to have lower postpartum weight retention at 6 months after delivery. Weight and behavioral goals will be promoted through the COACH Plan, a behavioral model guiding coaching calls, behavioral tracking targets and learning activities. Coaches will refer to home visitors for additional support and community resources, based on an established protocol. * Telephone health coaching calls by trained health coaches. Calls start at enrollment, between 20-33-weeks gestation through 6 months postpartum. Although coaching calls will occur by phone or Zoom (\~20 mins), when possible, some coach contact could occur at the time of home visits in person. * Online interactive learning activities. Literacy adaptation ensured Learning Activities are at <5th grade reading level. All activities are translated into Spanish and culturally adapted to create a parallel program. Online learning activities contain embedded images (people and settings) that reflect the diversity of the investigators' target population, examples of activities that are readily available in the community and maximize the use of white space, large text and simple graphics to enhance readability and accessibility of the educational content. The investigators enhanced the platform to enable an interactive goal-setting functionality for participants to set health goals paced with participants' Learning Activities and calls. The online program is maintained and monitored by the study's health coach managers. * Health behavior tracking (diet and exercise). Participants will receive specific skill-building on how to track diet and exercise behaviors via mainstream mobile app or paper/pencil, using procedures from the investigators' current trial. Coaches will be able to discuss tracking data with participants. Mainstream tracking apps are available in both Spanish and English. * Weekly self-weighing. Participants will be asked to weigh themselves weekly at home using the participants' study scale.

Título OficialEffectiveness of Health Coaching to Reduce Cardiometabolic Risk in Early Home Visiting Services
NCT05619705
Patrocinador PrincipalJohns Hopkins University
Contacto del EstudioKelly M Bower, PhD, MSN/MPHMás contactos
Última actualización: 28 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 360 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Prevención

Los estudios de prevención buscan evitar que se desarrolle una enfermedad. A menudo incluyen a personas en riesgo y evalúan vacunas, cambios en el estilo de vida o medicamentos preventivos.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Mujer

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

Aumento de Peso GestacionalCambios en el Peso CorporalPeso CorporalEnfermedades Nutricionales y MetabólicasObesidadTrastornos de la NutriciónSignos y SíntomasCondiciones Patológicas, Signos y SíntomasGanancia de peso

Criterios

7 criterios de inclusión requeridos para participar
Pregnant, ≤33 weeks gestation

Singleton pregnancy

Pre pregnancy BMI≥25.0 Kg/m^2 (calculated based on self-reported pre pregnancy height and weight)

Able to provide informed consent

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8 criterios de exclusión impiden participar
Type 1 diabetes or taking insulin prior to delivery

Pregnant with multiple fetuses

Unable to walk 1 block without pain or shortness of breath

Not cleared by the study's clinicians or home visiting program staff

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Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
Those assigned to the intervention group will receive the 8 to 11 month H42 health coaching intervention in addition to usual home visiting and usual prenatal and postpartum care clinical services. Intervention duration will depend on the participant's gestational age at the of enrollment. Participants can be enrolled as early in pregnancy as 20 weeks gestation and as late as 33 weeks gestation. All participants would be enrolled for 6 months postpartum. Therefore, the minimum time in the intervention would be 8 months and maximum would be 11 months.

Grupo II

Comparador Activo
Those assigned to the "usual home visiting plus" comparison group, called maintain health in pregnancy and postpartum (mHIPP), will receive the typical, evidence-based experience in participants' home visiting program in addition to the participants' usual prenatal and postpartum care clinical services. In addition, the investigators will provide a brief (less than 5 minutes) maternal warning signs educational video that is available in English or Spanish. The video was developed for a home visiting client audience and is publicly available, https://mdmom.org/warningsigns.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

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Johns Hopkins School of Nursing

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