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- Ensaio Clínico NCT02829229
Community-based Obesity Treatment in African American Women After Childbirth
6 de julho de 2022 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
300
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19140
- Temple University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Weight loss (kilograms)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Obesogenic dietary behaviors
Prazo: At baseline and 12 months
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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
Prazo: 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
Prazo: At baseline and 12 months
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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
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Physical Activity
Prazo: At baseline and 12 months
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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
Prazo: At baseline and 12 months
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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
Prazo: 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
Prazo: 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
Prazo: At baseline and 12 months
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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)
Prazo: At baseline and 12 months
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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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Utilize Reach Effectiveness Adoption Implementation (RE-AIM) to evaluate the intervention's dissemination potential
Prazo: 12 months
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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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sharon J Herring, MD MPH, Temple University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de setembro de 2016
Conclusão Primária (Real)
1 de janeiro de 2021
Conclusão do estudo (Real)
1 de junho de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
28 de janeiro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de julho de 2016
Primeira postagem (Estimativa)
12 de julho de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
7 de julho de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de julho de 2022
Última verificação
1 de julho de 2022
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 23187
- R01HL130816 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Community-based obesity treatment (PP)
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