Project HERA (Health, Education, and Relationship-building for Adolescents- Moms and Tots) (Project HERA)
9 de abril de 2015 atualizado por: University of Massachusetts, Worcester
Helping Ethnically Diverse Teen Moms Prevent Obesity in Their Preschool Children
Specific Aims:
- The primary aims of this study are to conduct formative interviews with teen mothers to inform a targeted adaptation of empirically based weight management and parent training programs for teen mothers for their preschoolers.
- To conduct a small pilot and post-pilot focus group of the feasibility and acceptability of recruitment and retention methods & the intervention.
Study Hypotheses:
Given the small sample size and fact that this is a pilot study, focus will be on estimating effect sizes rather than statistical hypothesis testing. However, the investigators exploratory hypotheses are as follows:
- (a) The adapted intervention will be more feasible compared to the wellness control condition, with a participant retention rate of ≥80% and an average adherence (attendance at weekly treatment sessions; homework completion 5 weekdays weekly) is ≥ 75%; (b) The adapted intervention will be more acceptable compared to the wellness control condition, based on the Consumer Satisfaction Scale and Therapy Assessment Inventory with ≥90% of the participants responding to the item, "In general how satisfied were you with the intervention?" by choosing "unsatisfied" to "very satisfied."
- (a) The adapted intervention will result in greater improvements in child behavior and parent-child connectedness compared to the control condition; (b) the adapted intervention versus wellness control condition will result in greater increases in child and teen mother individual as well as joint physical activity and physically active play and greater reductions in individual and joint teen mother and child sedentary behavior (television viewing) from baseline to post-intervention; (c) the greater teen mother and child fruit and vegetable consumption; and reduced child juice and sugar-sweetened beverage consumption from baseline to post-intervention; (d) the adapted intervention versus wellness control condition will result in smaller increases in child BMI percentile and teen mother BMI from baseline to post-intervention; (e) participants who attend higher numbers of intervention sessions will show greater improvements in target outcomes (child behavior, parent-child connectedness, and teen mother and child physical activity, sedentary behavior and BMI); with participants receiving the adapted intervention versus wellness control showing the greatest dose-based improvements.
Visão geral do estudo
Status
Concluído
Tipo de estudo
Intervencional
Inscrição (Real)
25
Estágio
- Fase 2
- Fase 1
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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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01655
- UMASS
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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
16 anos a 20 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- Must be teen moms
- Be between 16 and 20 years of age
Exclusion Criteria:
- Does not have a child between the ages of 6 months and 5 years
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: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Parent Training/Obesity Prevention
Mother-child dyads randomized to the active intervention in the pilot study will be administered 8 weeks of a combined parenting training and obesity prevention program that was adapted through analysis of formative research interviews with adolescent mothers with feedback from an expert panel of multidisciplinary research team members and community members.
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Comparador Ativo: 8-week Wellness Program (Control)
Participants randomized to control condition during intervention piloting will receive print-based health and wellness materials once weekly for 8-weeks + 2 follow up telephone calls at the beginning and conclusion of the 8-week program.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Study Feasibility
Prazo: Measured at the beginning of participant recruitment through 8 weeks follow up (end of treatment)
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Feasibility will be assessed during intervention piloting using process evaluation data to determine the pace of recruitment relative to sample size goals and differences in retention by condition.
Descriptive analyses will determine the % of participants recruited, rate of accrual, attrition rate over time and total, % accepting randomization to treatment, and % compliance with study protocols (as measured by number of sessions attended, number who complete homework, etc…).
Due to the small sample size in the current study, the intervention will be considered feasible if the retention rate is ≥ 80% and if the average adherence (attendance at weekly treatment sessions; homework completion 5 weekdays weekly) is ≥ 75%.
The post pilot focus group will probe participants about their perspective on methods used to recruitment them into the study, including advertisements, incentives, location etc...
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Measured at the beginning of participant recruitment through 8 weeks follow up (end of treatment)
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Study Acceptability
Prazo: 8-weeks follow up (end of treatment)
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We will assess study acceptability via maternal completion of customer satisfaction questionnaires at the end of treatment (8 weeks follow up) for participants randomized (n=46) during intervention piloting to the adapted intervention (combined parenting/obesity prevention program) versus control condition (wellness program).
We will invite a subsample of n=8 adolescent mothers to participate in the post-pilot focus group to further assess study acceptability and probe these participants on the likes and dislikes for the program, and recruitment methods.
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8-weeks follow up (end of treatment)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in Child Problem Behavior
Prazo: Baseline, Each week for 8 weeks during active treatment, and 8-weeks follow up (end of treatment)
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We will assess for changes in child problem behavior via maternal completion of child behavior questionnaires administered at baseline, once weekly for eight weeks during active intervention, and at 8 weeks end of treatment (follow up) for participants randomized (n= 46) to the intervention arm (parenting/combined obesity prevention program) versus control (wellness condition).
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Baseline, Each week for 8 weeks during active treatment, and 8-weeks follow up (end of treatment)
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Change in Child Physical Activity/Sedentary Behavior
Prazo: Baseline, 8-weeks follow up (end of treatment)
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Child physical activity and sedentary behavior will be measured via maternal completion of questionnaires administered at baseline and 8 weeks follow up to assess for changes in these outcomes across participants randomized during intervention piloting (n=46) to the intervention condition (combined parenting/obesity prevention program) versus control condition (wellness program).
Child physical activity and sedentary behavior will also be assessed via a home audit of the home physical activity/sedentary behavior environment completed by the research assistant at baseline and 8-weeks follow up (end of treatment)
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Baseline, 8-weeks follow up (end of treatment)
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Change in Child fruit, Vegetable, Junk, Fat and Fast food Intake (Child Nutritional Behavior)
Prazo: Baseline, 8-weeks follow up (end of treatment)
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Child nutritional behavior will be measured via maternal completion of questionnaires administered at baseline and 8 weeks follow up to assess for changes in these outcomes across participants randomized during intervention piloting (n=46) to the adapted intervention condition (combined parenting/obesity prevention program) versus control condition (wellness program).
Child nutritional behavior will also be assessed via a home audit completed by the research assistant at baseline and 8-weeks follow up (end of treatment).
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Baseline, 8-weeks follow up (end of treatment)
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Change in Child Weight Status (BMI percentile)
Prazo: Baseline, 8-weeks follow up (end of treatment)
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We will measure child height and weight at baseline and 8-weeks follow up (end of treatment) to calculate child BMI percentile to assess for changes in BMI percentile for participants randomized during intervention piloting (n=46) to the adapted intervention condition (combined parenting/obesity prevention program) compared to those in the control condition (wellness program).
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Baseline, 8-weeks follow up (end of treatment)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
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
1 de abril de 2013
Conclusão Primária (Real)
1 de setembro de 2014
Conclusão do estudo (Real)
1 de setembro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
12 de julho de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de julho de 2014
Primeira postagem (Estimativa)
25 de julho de 2014
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
10 de abril de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de abril de 2015
Última verificação
1 de abril de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 14864
- R21HL114083 (Concessão/Contrato do NIH dos EUA)
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 .