Refeições caseiras mais saudáveis para gestantes (Her HOME)
Uso de refeições entregues em casa para reduzir o ganho de peso gestacional excessivo para mulheres de alto risco
This study is being done to test the feasibility, acceptability, and preliminary efficacy of a meal delivery intervention for managing gestational weight gain among pregnant women with overweight or obesity.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama at Birmingham
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age ≥ 18 years
- Gestational age ≤ 15 weeks as assessed by ultrasound
- Body mass index (BMI) ≥ 25 kg/m2
- Singleton viable pregnancy
- Receiving care and planning to deliver at UAB
- Residing within the delivery radius of the meal delivery company
- Wi-Fi or Bluetooth Internet connection in home (for digital Wi-Fi enabled study scale)
Exclusion Criteria:
- Self-reported major health conditions (e.g., heart disease, cancer, renal disease, and Type 1 or Type 2 diabetes)
- Current substance abuse
- Current treatment for serious psychiatric disorder (schizophrenia, bipolar disorder)
- Known fetal anomaly
- Planned termination of pregnancy
- Past history or current diagnosis of anorexia or bulimia
- Current use of one or more of the following medications:
- Metformin
- Systemic steroids
- Antipsychotic agents
- Anti-seizure medications or mood stabilizers that would be expected to have a significant impact on body weight
- Medications for ADHD including amphetamines and methylphenidate
- Any teratogenic agent Class D
- Participation in another dietary and/or weight management intervention during pregnancy
- Unwilling or unable to consume prepared meals delivered weekly
- Unable to understand and communicate in verbal and written English
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention
Meal delivery intervention with brief behavioral support. |
10 healthy, home-delivered meals per week + brief weekly remote behavioral support |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Weight From First to Last Prenatal Visit
Prazo: First prenatal visit (<=15 weeks gestation), last prenatal visit (35+ weeks gestation)
|
Weight measured at the first and last prenatal visits will be retrieved from medical records for all participants and used to calculate total weight change from the first to the last prenatal visit (i.e., gestational weight gain). |
First prenatal visit (<=15 weeks gestation), last prenatal visit (35+ weeks gestation)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Food Insecurity
Prazo: baseline (12-15 weeks gestation), (35-36 weeks gestation)
|
Determined using the 18-item United States (US) Household Food Security Survey Module based on the previous 30 days. Adult food security scores range from 0 to 10, with lower values indicating greater food security. Change in Food Security was calculated as food security score at follow up minus score at baseline, with negative values indicating an increase in food security from baseline to follow up. |
baseline (12-15 weeks gestation), (35-36 weeks gestation)
|
|
Change in Perceived Stress
Prazo: baseline (12-15 weeks gestation), (35-36 weeks gestation)
|
Determined using the 10-item Perceived Stress Scale (PSS-10) based on the last month. PSS-10 scores range from 0 to 40, with higher scores representing higher levels of perceived stress. Change in Perceived Stress score was calculated as score at follow up minus score at baseline, with positive values indicating an increase in perceived stress score from baseline to follow up. |
baseline (12-15 weeks gestation), (35-36 weeks gestation)
|
|
Change in Participant Satisfaction With Diet
Prazo: baseline (12-15 weeks gestation), (35-36 weeks gestation)
|
To assess satisfaction with the study intervention, the 28-item Diet Satisfaction Questionnaire (DSAT-28) will be used in which participants respond to 28 statements using a 5-point Likert scale. Responses to all 28-items are averaged to produce a total diet satisfaction score (designed to reflect satisfaction as it relates to following a weight-management diet) ranging from 1-5. Subscale scores for Cost Factor (reflects financial cost of the diet) and Planning & Preparation Factor (reflects amount of time and effort spent in planning and preparing) will also be calculated and range from 1-5. For the overall diet satisfaction score and subscale scores, higher scores represent greater satisfaction. Changes in overall diet satisfaction, as well as changes in subscale scores for Cost Factor and Planning & Preparation Factor are calculated as score at follow up minus score at baseline, with positive values indicating an increase in satisfaction) from baseline to follow up. |
baseline (12-15 weeks gestation), (35-36 weeks gestation)
|
|
Proportion of Women Exceeding Institute of Medicine Gestational Weight Gain Guidelines
Prazo: First prenatal visit (<=15 weeks gestation), last prenatal visit (35+ weeks gestation)
|
Weight at the first prenatal visit will be subtracted from weight at the last prenatal visit. Women will be categorized as exceeding 2009 Institute of Medicine gestational weight gain guidelines if the difference is > 11.5 kg gain for women with overweight or >9 kg for women with obesity at the first prenatal visit. |
First prenatal visit (<=15 weeks gestation), last prenatal visit (35+ weeks gestation)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Gareth Dutton, PhD, University of Alabama at Birmingham
- Investigador principal: Camille Worthington, PhD, University of Alabama at Birmingham
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Distúrbios Nutricionais
- Doenças urogenitais femininas e complicações na gravidez
- Supernutrição
- Peso corporal
- Complicações na Gravidez
- Alterações de Peso Corporal
- Excesso de peso
- Obesidade
- Ganho de peso
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Ganho de Peso Gestacional
- Gravidez na obesidade
Outros números de identificação do estudo
- IRB-300009275
- R21HD107325 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
De-identified individual participant data (IPD) that underlie the results reported in a publication will be made available upon request beginning 9 months and ending 36 months following article publication. The research team will keep a record of all individuals and/or research teams who request and receive a copy of the project data. Interested investigators will be asked to submit a document indicating the specific aims of the analyses, the analytic plan, available resources for completing the proposed project, proposed timeline, and goals (i.e., manuscripts, presentations, and/or grant applications). The PI and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed.
Prazo de Compartilhamento de IPD
Data requests can be submitted starting 9 months after publication of results and ending 36 months following article publication.
Critérios de acesso de compartilhamento IPD
Access to IPD stripped of all HIPAA identifiers (except age) for this study can be requested by qualified researchers engaging in independent scientific research whose proposed research has received Institutional Review Board approval, and will be provided following review and approval of a research proposal and timeline, statistical analysis plan, and goals (e.g., manuscripts, presentations, grant applications). The Principal Investigator (PI) and research team will review these requests to determine whether the proposed analyses constitute an innovative and significant exploration of the data, whether the proposed team has sufficient resources to complete the request, and whether data will be adequately protected and managed. Based on institutional policies, execution of a Data Sharing Agreement may be required prior to sharing of IPD. IPD requests can be made to the MPIs at gdutton@uabmc.edu or cschneid@uab.edu.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CIF
Informações sobre medicamentos e dispositivos, documentos de estudo
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