Foundations of Fitness Program Pilot
8 de julho de 2019 atualizado por: Auden McClure, Dartmouth-Hitchcock Medical Center
Foundations of Fitness: A Clinic-Community Partnership to Address Pediatric Obesity
Approximately 17% of US children have obesity resulting in significant childhood co-morbidities and increased lifetime risk of adult obesity, diabetes, cardiovascular disease and cancer.
Guidelines recommend intensive lifestyle programs as first-line treatment, yet few pediatric practices are equipped to provide this.
Clinical-community partnerships are well-positioned to address this care gap.
This proposal aims to assess whether a community-delivered lifestyle program offered in adjunct to primary care obesity management is feasible, acceptable, effective, and easily implemented in a rural care setting.
In this study, approximately 40 children aged 7-13 years old and their caregiver pairs will be recruited from a primary care pediatric clinic.
Child-adult dyads will participate in a 24-week program that includes 2 phases, a 12-week usual care phase and a 12-week intervention phase.
The intervention phase will include bi-weekly meetings of a community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change.
A mixed-methods approach using qualitative interviews and study questionnaires, combined with objective measures of adiposity and fitness will assess study outcomes.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
29
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
-
-
New Hampshire
-
Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth-Hitchcock Medical Center
-
-
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
7 anos a 13 anos (Filho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Age 7-13 years;
- BMI% ≥85th%;
- Regional pediatric medical home patient;
- English speaking child and parent/caregiver;
Exclusion Criteria:
- Physical or developmental limitation to participation as determined by referring provider
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: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 7-10 years old
Children-caregiver pairs will participate in a 24-week pilot that includes 2 phases, 12 weeks of usual care, followed by 12 weeks of Foundations of Fitness Program.
|
The Foundations of Fitness Program is a 12 week, bi-weekly community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change, components supported by USPSTF evidence review.
Class sessions, which involve both parent/caregiver and child will include structured fitness activities, hands on nutrition, cooking, shopping and meal planning and facilitated discussions about goal setting, self-monitoring, stimulus control and healthy homes and families.
Content will be offered in a context that supports self-esteem and behavior change.
The program was developed by the Carter Community Building Association (CCBA) in collaboration with the Dartmouth-Hitchcock Weight & Wellness Center research core.
|
|
Experimental: 11-13 years old
Children-caregiver pairs will participate in a 24-week pilot that includes 2 phases, 12 weeks of usual care, followed by 12 weeks of Foundations of Fitness Program.
|
The Foundations of Fitness Program is a 12 week, bi-weekly community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change, components supported by USPSTF evidence review.
Class sessions, which involve both parent/caregiver and child will include structured fitness activities, hands on nutrition, cooking, shopping and meal planning and facilitated discussions about goal setting, self-monitoring, stimulus control and healthy homes and families.
Content will be offered in a context that supports self-esteem and behavior change.
The program was developed by the Carter Community Building Association (CCBA) in collaboration with the Dartmouth-Hitchcock Weight & Wellness Center research core.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Program Feasibility based on program attendance and completion of assessments to determine if children are willing and interested in to attending a fitness program.
Prazo: 24 weeks
|
Programmatic feasibility will be defined as delivery of 100% of the sessions with 80% of children attending ≥75% of sessions and 80% completing pre- and post-assessments.
|
24 weeks
|
|
Program Acceptability based on interviews evaluating the appropriateness of the pilot and assessing strengths/weaknesses.
Prazo: 24 weeks
|
Program acceptability will be assessed through semi-structured participant interviews ensuring the appropriateness of the pilot and assessing strengths/weaknesses.
|
24 weeks
|
|
Program Eligibility rate
Prazo: 24 weeks
|
Calculated using the following formula: [# screen positive / # screened for inclusion].
|
24 weeks
|
|
Program Enrollment rate
Prazo: 24 weeks
|
Calculated using the following formula: [# enrolled / (# screen positive & eligible)].
We will assess reasons for dropout/non-adherence.
|
24 weeks
|
|
Program Completion rate
Prazo: 24 weeks
|
Calculated using the following formula: (# completing all sessions / # enrolled).
|
24 weeks
|
|
Assessment Completion rate
Prazo: 24 weeks
|
Calculated using the following formula: (# completing all assessments / # enrolled).
|
24 weeks
|
|
Participant Satisfaction Survey
Prazo: 24 weeks
|
A 12 item survey at program conclusion will assess patient satisfaction with program elements (overall, class sessions, staff, assessments) using Likert scales (1-5 point scale - very dissatisfied=1 to very satisfied=5).
|
24 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Body Mass Index Percentile
Prazo: 48 weeks
|
Height (cm) and Weight (kg) will be used to calculate body mass index (kg/m^2) and then BMI percentile (%) using Center for Disease Control 2000 standards.
|
48 weeks
|
|
Strength Assessment
Prazo: 24 weeks
|
Assessed through 5 exercises including: leg extension, leg curl, lap pull down, shoulder press, chest press.
Units for all are number of repetitions per minute at a fixed mass (lbs).
|
24 weeks
|
|
Health Habits Survey
Prazo: 24 weeks
|
The Weight & Wellness Center Health Habits Survey assesses diet, activity, media and sleep behaviors through 46 individual survey questions with variable response categories (for example, overall physical activity is assessed using a 0-5 point Likert scale with higher score related to better physical activity level: " Overall my physical activity level is": Poor=0 - Excellent=5)
|
24 weeks
|
|
Subjective Health and Quality of Life Score
Prazo: 24 weeks
|
The Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Health 7 survey (child and parent proxy) is a 7-question survey (Score 7-35) capturing physical, mental, and social aspects of quality of life using Likert scales (1-5 point scale: poor/never=1 to excellent/always=5). Higher score indicates more positive perceptions of overall health.
|
24 weeks
|
|
Sense of Belonging in Fitness Program Score
Prazo: 24 weeks
|
The Anderson-Butcher and Conroy Sense of Belonging survey is a 5-item questionnaire measuring sense of belonging experienced by children participating in a Fitness Program using Likert scale (1-4 point scale: NO!=1, no=2, yes=3, and YES!=4).
Total Score Range 5-20: A higher score indicates a greater sense of belonging.
|
24 weeks
|
|
Self Esteem Score
Prazo: 24 weeks
|
The Rosenberg Self-Esteem survey is a 10-item questionnaire measuring self-esteem of children participating in a Fitness Program using Likert scale (0-3 point scale: Strongly disagree=0 to Strongly agree=3).
Total Score Range 0-30: Higher scores indicate greater self-esteem.
|
24 weeks
|
|
Physical Activity Score
Prazo: 24 weeks
|
The Patient Reported Outcomes Measurement Information Systems (PROMIS) is a short form 4-question survey (Score 4-20) assessing physical activity over the past seven days using Likert scales (1-5 point scale: No days=1, 1 day=2, 2-3 days=3, 4-5 days=4, and 6-7 days=5).
Higher score indicates higher levels of physical activity.
|
24 weeks
|
|
Cardio-capacity
Prazo: 24 weeks
|
Distance (m) on treadmill at 65% of max heart rate.
|
24 weeks
|
|
Heart Rate
Prazo: 24 weeks
|
Resting and recovery heart rate (BPM) measured before and after treadmill test.
|
24 weeks
|
|
Blood Pressure
Prazo: 24 weeks
|
Resting and recovery systolic and diastolic Blood pressure (mmHg) measured before and after treadmill test.
|
24 weeks
|
|
Waist Circumference
Prazo: 24 weeks
|
Waist circumference will be measured (cm)
|
24 weeks
|
|
Perceived Athletic Competence Score
Prazo: 24 weeks
|
The Harter Self-Perception Profile for Children is a short form 6-question survey (score 1-4) assessing athletic competence using a two-choice format with option then of checking "Sort of True for Me" or "Really True for Me" (A score of 1 indicates lowest and a score of 4 highest level of perceived athletic competence).
|
24 weeks
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Staff program adoption
Prazo: 24 weeks
|
Staff program adoption will be assessed using semi-structured interviews assessing staff experience with workflow and adoption of Foundations of Fitness Program.
|
24 weeks
|
|
Fidelity to planned program
Prazo: 24 weeks
|
We will assess percent of planned class sessions and planned outcome assessments that were administered.
|
24 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Auden C McClure, MD MPH, Dartmouth-Hitchcock Medical Center
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)
12 de julho de 2018
Conclusão Primária (Real)
12 de junho de 2019
Conclusão do estudo (Real)
12 de junho de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
18 de julho de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de agosto de 2018
Primeira postagem (Real)
9 de agosto de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de julho de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de julho de 2019
Última verificação
1 de julho de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- D18143
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .