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O estudo clínico NCT03950453 para Obesidade infantil está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Universidade YalePreventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT03950453 é um ensaio intervencionista para Obesidade infantil. Seu status atual é: ativo, não recrutando. O estudo começou em 11 de novembro de 2018 e pretende incluir 246 participantes. Coordenado por a Universidade Yale e deve ser concluído em 31 de outubro de 2024. Essas informações foram atualizadas no ClinicalTrials.gov em 15 de fevereiro de 2024.
Resumo
This study will examine the mediator/moderator variables that affect efficacy of a parent stress intervention with nutrition education (PMH+N: parenting mindfully for health) vs. Control intervention with nutrition education (CTL+N) on parent stress, parenting, health behaviors and child obesity risk. A non-randomized historical control group will also be assessed during the intervention and follow-up periods throughout to obtain outcome assessment without any interventions being provided.
Descrição detalhada
This is a 5-year interdisciplinary project to assess a 12-week Parenting Mindfully for Health (PMH) + nutrition counseling (N) versus contact control intervention (C) + nutrition counseling (N), to examine short-term and long term enduring effects of PMH+N to promote healthy eating and physical activity in parent and child, and prevent childhood obesity risk in 2-5 year olds, via changes in parent stress and parenting. A non-randomized historical control group will also be assessed during the intervention and follow-up periods throughout to obtain outcome assessment without any interventions being provided.
Título oficial
Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention
Condições
Obesidade infantilOutros IDs do estudo
Número NCT
Data de início (real)
2018-11-11
Última atualização postada
2024-02-15
Data de conclusão (estimada)
2024-10-31
Inscrição (estimada)
246
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ativo, não recrutando
Propósito principal
Prevenção
Alocação do design
Randomizado
Modelo de intervenção
Atribuição paralela
Cegamento (Mascaramento)
Duplo-cego (Mascaramento duplo)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalParenting Mindfully for Health Nutrition (PMH) Parenting Mindfully for Health (PMH) + nutrition and physical activity counseling to promote healthy eating and physical activity in parent and child. | Parenting Mindfully for Health Nutrition (PMH) PMH will include included the following components:
1. mindfulness strategies as outlined in the MBSR manual,
2. mindful parenting concepts,
3. mindful eating and awareness of family choices;
4. self and child monitoring of food intake, PA and emotional reactivity;
5. utilizing mindfulness for emotion regulation and distress tolerance,
6. behavioral strategies of goal setting and implementing increasing frequency of healthy food intake and physical activity (PA) |
Comparador ativoContact Control Nutrition (C+N) Contact control intervention (C) + nutrition and physical activity counseling (N). | Contact Control Nutrition (C+n) Contact Control Group where parents engage in a quiet, relaxing, but stimulating activity and also nutrition counseling. |
OutroHistorical Control (WLC) non-randomized Non-randomized, historical control group with only assessments during intervention and follow-up period. | Non-randomized Historical Control (WLC) Assessment ONLY Non-randomized, historical control group with only assessments during intervention and follow-up period. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Parent Stress change from Pre to Post intervention | Parent stress measured by the Perceived Stress Scale scores ranging from 0-56 with higher scores indicating more stress. | Baseline Pre-intervention to Post intervention at 12 weeks |
Child BMI change post intervention and at short term 6 month follow-up | Child height will be measured with a measuring tape. For children, weight and height will be plotted on the CDC growth chart for the child's age to determine the BMI-for-age percentile scores. | Change from Pre-intervention to post-intervention (week 12) and at 6 month short term follow up |
Child food intake change | Parent report of child food frequency questionnaire assessment of frequency of healthy and unhealthy food intake. | Baseline Pre-intervention and at post-intervention (week 12) |
Parenting Behavior Change | Observed parenting behavior ratings for increase in positive parenting behaviors in the Toy Wait Task (TWT) | TWT parenting behavior ratings at Baseline Pre-intervention and at post-intervention (week 12) |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Parent Stress change from Post intervention to follow up period over 24-months | Parent stress measured by the Perceived Stress Scale scores ranging from 0-56 with higher scores indicating more stress. | Post intervention at 12 weeks to follow-up timepoints at 6-, 12-, 18- and 24- month timepoints |
Child BMI change at long term term follow-up | Child height will be measured with a measuring tape. For children, weight and height will be plotted on the CDC growth chart for the child's age to determine the BMI-for-age percentile scores. | Baseline compared to 12-month, 18-month and 24-month timepoint |
Child food intake change | Parent report of child food frequency questionnaire assessment of frequency of healthy and unhealthy food intake. | Baseline Pre-intervention and at post-intervention (week 12) |
Parenting Stress Inventory (PSI) | Parent reported PSI scores ranging from 18-90 with higher scores indicating higher parenting stress. | PSI scores at Baseline Pre-intervention and at post-intervention (week 12) and at follow-ups months 6-, 12-, 18- and 24 month timepoints |
Critérios de elegibilidade
Idades elegíveis
Criança
Idade mínima
2 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
- Family with a child between 2-5 years
- BMI of parent ≥30kg/m2
- Parents aged 18 yrs or older
- High parent stress (PSS mean score ≥25)
- Low income family as determined by HHS Poverty Guidelines
- Diagnosis of mental retardation, autism or other pervasive developmental disorder for child;
- Current serious psychiatric or medical disorder requiring immediate treatment, including active alcohol or substance use disorders (confirmed by urine toxicology screening and history), psychotic illnesses, suicidal ideation, untreated diabetes, cardiovascular disease, cancers or any other active current illnesses that preclude study participation for child or parent;
- Inadequate English proficiency to complete questionnaires.
Universidade Yale461 estudos clínicos ativos para explorarNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Sem dados de contato.
1 Locais do estudo em 1 países
Connecticut
The Yale Stress Center: Yale University, New Haven, Connecticut, 06519, United States