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- Ensayo clínico NCT02829229
Community-based Obesity Treatment in African American Women After Childbirth
6 de julio de 2022 actualizado por: Temple University
Community-based Obesity Treatment in African American Women After Childbirth: a Randomized Controlled Trial of Women Infant Children (WIC) Mothers
The purpose of this study is to determine the effect of the community-based obesity treatment (PP), compared to usual care (UC), on changes in maternal weight over 12 months.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The investigators propose to randomize overweight or obese, African American postpartum WIC participants (n=300) to either usual care (UC) or a community-based obesity treatment (PP) arm.
Recruitment will occur in 6 of Philadelphia Women Infants Children's (WIC) clinic sites in the early postpartum period (≤ 6 months after birth).
Once enrolled, participants will complete surveys and baseline assessments of their weight, waist circumference, blood pressure, and height at The Center for Obesity Research and Education (CORE).
Participants will also have a fasting blood sample taken.
Study staff will administer a number of questionnaires assessing demographics, psychosocial factors, contextual factors, and behavioral targets via questionnaires prior to randomization.
Participants will then be randomized to the 12-month postpartum weight loss intervention (PP) or usual care (UC).
Additional assessments will be conducted at 6 and 12 months post baseline.
The PP arm includes expanded obesogenic behavior change goals, tailored skills training materials, interactive self-monitoring text messages, video testimonials, and interpersonal counseling support through health coach calls and Facebook.
Data will be analyzed using an intent-to-treat (ITT) approach where subjects are analyzed according to their treatment assignment at randomization, regardless of level of engagement.
The primary outcome is weight loss at 12 months.
If successful, the expected results could provide a sustainable, low-cost, postpartum weight loss intervention model for widespread dissemination to reduce disparities in obesity and cardiometabolic comorbidities.
Tipo de estudio
Intervencionista
Inscripción (Actual)
300
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19140
- Temple University
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Self-identification as African American
- Self-report pre-pregnancy BMI between 25-49.9 kg/m2
- Measured BMI at baseline between 25-49.9 kg/m2
- Philadelphia WIC participant
- Singleton birth
- Between 1 and 6 months postpartum
- Own a cell phone with an unlimited text messaging plan
- Able to participate in light physical activity (walking)
- Participants must be willing to comply with all study-related procedures
- Participants must be able to read and write fluently in English
Exclusion Criteria:
- BMI ≤ 24.9 or ≥ 50.0 kg/m2
- Uncontrolled hypertension (systolic blood pressure > 160 or diastolic blood pressure > 95 mmHg). Participants with controlled hypertension on medication for at least three months are allowable.
- Known atherosclerotic cardiovascular disease
- Known congestive heart failure
- Known diabetes mellitus (type 1 or type 2)
- Known thyroid disease
- Any major active rheumatologic, pulmonary, hepatic, dermatologic disease or inflammatory condition requiring steroids or immune modulating medications
- History of testing HIV positive
- Current smoker or tobacco user. Participants with < 5 cigarettes daily are allowable
- Current or recent history (past 6 months) of drug or alcohol abuse or dependence
- Participation in any weight control or investigational drug study within 6 weeks of screening
- Current consumption of any of the following medications: appetite suppressants, anti-psychotics, lipase inhibitors
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety for successful participation in the study
- Gastrointestinal Disorders (gallbladder disease, Crohn's disease, etc)
- Previous weight loss surgery
- History of bulimia or anorexia
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Usual care (UC)
Usual postpartum WIC care
|
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Experimental: Community-based obesity treatment (PP)
The PP arm includes expanded obesogenic behavior change goals, tailored skills training materials, interactive self-monitoring text messages, video testimonials, and interpersonal counseling support through health coach calls and Facebook.
|
Participants in the treatment (PP) arm will receive a 5-component intervention: 1)Behavior change goals; 2)Self-monitoring; 3)Tailored skills training; 4)Video testimonials & 5)Interpersonal counseling.
Both treatment and usual care arms will receive the current standard of care offered to postpartum mothers at WIC.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Weight loss (kilograms)
Periodo de tiempo: At baseline and 12 months
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Weight will be measured using a calibrated scale at baseline and 12-month follow-up.
Weight loss will be calculated as the difference between mean 12-month and baseline weight in kilograms.
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At baseline and 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Obesogenic dietary behaviors
Periodo de tiempo: At baseline and 12 months
|
Using National Cancer Institute's Diet History Questionnaire, the investigators will assess categories of sugary drink intake, fast/fried food intake, and snacking at baseline and 12-month follow-up.
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At baseline and 12 months
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Insulin Resistance
Periodo de tiempo: At baseline and 12 months
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Blood will be drawn to assess insulin resistance (insulin and glucose).
The Homeostatic model assessment for Insulin Resistance (HOMA-IR) calculation will be used to quantify participant mean insulin resistance at baseline and 12-month follow-up.
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At baseline and 12 months
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Health-related quality of life
Periodo de tiempo: At baseline and 12 months
|
Short Form-12 (SF-12) questionnaire will be used to collect health-related quality of life at baseline and 12-month follow-up.
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At baseline and 12 months
|
Physical Activity
Periodo de tiempo: At baseline and 12 months
|
Wrist Actigraphy will be used to measure physical activity (average number of steps) at baseline and 12-month follow-up.
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At baseline and 12 months
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Physical Activity
Periodo de tiempo: At baseline and 12 months
|
Wrist Actigraphy will be used to measure physical activity (average intensity of activity) at baseline and 12-month follow-up.
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At baseline and 12 months
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Sleep
Periodo de tiempo: At baseline and 12 months
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Wrist Actigraphy will be used to measure sleep (mean duration of sleep) at baseline and 12-month follow-up.
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At baseline and 12 months
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Sleep
Periodo de tiempo: At baseline and 12 months
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Wrist Actigraphy will be used to measure sleep (mean sleep efficiency) at baseline and 12-month follow-up.
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At baseline and 12 months
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Sleep
Periodo de tiempo: At baseline and 12 months
|
Wrist Actigraphy will be used to measure sleep (mean wake after sleep onset) at baseline and 12-month follow-up.
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At baseline and 12 months
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Hemoglobin A1c (HbA1c)
Periodo de tiempo: At baseline and 12 months
|
Hemoglobin A1c test will be performed by a lab to identify the 3-month average plasma glucose concentration at baseline and 12-month follow-up.
The investigators will categorize participants as no diabetes (HbA1c <5.7), prediabetes (HBA1c 5.7-6.4), and diabetes (HBA1c >6.4) at both timepoints.
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At baseline and 12 months
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Lipids
Periodo de tiempo: At baseline and 12 months
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Total cholesterol test will be performed by a lab to identify mean total blood cholesterol level, low density lipoprotein and high density lipoprotein levels at baseline and 12-month follow-up.
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At baseline and 12 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Utilize Reach Effectiveness Adoption Implementation (RE-AIM) to evaluate the intervention's dissemination potential
Periodo de tiempo: 12 months
|
The five steps are Reach the target population; Effectiveness; Adoption by target staff, settings or institutions; Implementation consistency, costs and adaptions made during delivery and Maintenance of intervention effects in individuals and settings over time.
Previously collected data such as target population characteristics; attrition and completion percentages; results related to primary, secondary and unintended outcomes; intervention fidelity; participant knowledge application and sustainability will be used within scope of 5 steps to determine dissemination potential.
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12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sharon J Herring, MD MPH, Temple University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de septiembre de 2016
Finalización primaria (Actual)
1 de enero de 2021
Finalización del estudio (Actual)
1 de junio de 2021
Fechas de registro del estudio
Enviado por primera vez
28 de enero de 2016
Primero enviado que cumplió con los criterios de control de calidad
7 de julio de 2016
Publicado por primera vez (Estimar)
12 de julio de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de julio de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
6 de julio de 2022
Última verificación
1 de julio de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 23187
- R01HL130816 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Dr. Herring (PI) will ensure that all publications that result from data collected as part of this project will comply with the NIH public access policy.
Also, Dr. Herring agrees to develop a transportable de-identified database, codebook, and mechanism by which data can be shared with other investigators upon approval of the study's research team.
The Resource Sharing Plan will be reviewed and approved by Temple University's Institutional Review Board.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .