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iAmHealthy Parents First: Um Programa de Obesidade de Pais e Filhos em Televídeo para Famílias na Zona Rural do Kansas

29 de setembro de 2026 atualizado por: University of Kansas Medical Center

The purpose of this study is to assess whether providing a parent-only group program before providing a parent and child group program works better than the parent and child group program alone.

Visão geral do estudo

Descrição detalhada

The goal of this project is to determine if an adult intervention followed by a family-based program (iAmHealthy Parents First) will result in a larger percentage of weight loss in parents and children compared to solely a family-based program (iAmHealthy). Furthermore, the investigators aim to discover if administering iAmHealthy Parents First will improve dietary intake, physical activity, and weight-related quality of life among parents and children when compared to iAmHealthy. Parent/child dyads will be recruited from rural elementary schools, medical clinics, and organizations across Kansas and neighboring states.

Tipo de estudo

Intervencional

Inscrição (Real)

410

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

    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • University of Kansas 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

6 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Family lives in a rural area (city and/or county population <20,000) or as defined by RUCA codes, Urban Influence Codes, amount of agricultural income, or individual commuting patterns
  • Child BMI%ile ≥ 85th and parent BMI 25-50 kg/m2
  • Child in 1st-5th grade or 6-11 years of age
  • Child and parent speak English
  • Family is available at times intervention is offered

Exclusion Criteria:

  • For parents: new MI, stroke or cancer diagnosis in past 6 months, recent bariatrics surgery (within 2 years) or planned within 1 year, pregnancy in last 6 months or planned within 1 year

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: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: iAmHealthy Parents First

iAmHealthy Parents First families will take part in a group program with other adults over Zoom. Children will not be involved during this time. Adults will participate in these group sessions weekly for three months. Each meeting will last approximately an hour. Half of the dyads from each cohort will be randomized to the iAmHealthy Parents First group.

After 3 months, both iAmHealthy Parents First and iAmHealthy families will take part in an educational group program with parents and their children. These meetings will be focused on living healthy lifestyles and engaging in healthy habits as a family and will occur three weeks out of four for four months. There will be three additional family-based group sessions spread over the final two months of the program. iAmHealthy Parents First adults will continue to meet monthly during the family-based program (on weeks when the family-based group does not meet) to continue the adult program.

iAmHealthy Parents first is a 3-month adult obesity treatment program targeting the unique needs of adults with school-age children. Following the iAmHealthy Parents First program, these dyads will take part in a 6-month family-based healthy lifestyles program.

Comparador Ativo: iAmHealthy

iAmHealthy families will receive an informational newsletter once a month for three months. This group will be given the flexibility to start their weight loss journey using self-guided methods. No formal group sessions will be provided for three months. Half of the dyads from each cohort will be randomized to the iAmHealthy group.

After 3 months, both iAmHealthy Parents First and iAmHealthy families will take part in an educational group program with parents and their children. These meetings will be focused on living healthy lifestyles and engaging in healthy habits as a family and will occur three weeks out of four for four months. There will be three additional family-based group sessions spread over the final two months of the program.

The iAmHealthy group will receive newsletters for three months. Following this period, these dyads will take part in a 6-month family-based healthy lifestyles program.

Outro: iAmHealthy Parents First, Pilot, Non-Randomized

Non-randomized feasiblity group. iAmHealthy Parents First families will take part in a group program with other adults over Zoom. Children will not be involved during this time. Adults will participate in these group sessions weekly for three months. Each meeting will last approximately an hour. After 3 months, families will take part in an educational group program with parents and their children. These meetings will be focused on living healthy lifestyles and engaging in healthy habits as a family and will occur three weeks out of four for four months. There will be three additional family-based group sessions spread over the final two months of the program. Adults will continue to meet monthly during the family-based program (on weeks when the family-based group does not meet) to continue the adult program.

iAmHealthy Parents first is a 3-month adult obesity treatment program targeting the unique needs of adults with school-age children. Following the iAmHealthy Parents First program, these dyads will take part in a 6-month family-based healthy lifestyles program.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percent weight change in parents and BMIz (BMI z-score) in children
Prazo: Baseline, 3 months, 9 months

Parents and children will measure body weight on a study-provided digital scale following instructions provided by study team.

Baseline, 3 months, 9 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Mediator: Attendance
Prazo: Baseline, 3 months, 9 months

Group and individual session attendance (percent of sessions) will be tracked on REDCap, a secure, web-based application designed exclusively to support data capture for research studies.

Baseline, 3 months, 9 months
Mediator: Reciprocal modeling
Prazo: Baseline, 3 months, 9 months

Reciprocal influence (parent response as mediator for child; child response as mediator for parent) will be operationalized as adult or child weight loss.

Baseline, 3 months, 9 months
Moderator: Family functioning
Prazo: Baseline, 3 months, 9 months

Family functioning will be measured using the Family Assessment Device (FAD). This is the gold-standard measure of structural, organizational, and transactional characteristics of families including general family functioning (core scale of interest) and 6 additional subscales: affective involvement, affective responsiveness, behavioral control, communication, problem solving, and roles. This questionnaire will be completed by adults. The FAD is scored by adding responses of each scale (1 - 4) and dividing by the number of items in each scale (between 6 - 12). The higher the overall score, the worse the level of family function.

Baseline, 3 months, 9 months
Moderators: Genetic casual attributions
Prazo: Baseline, 3 months, 9 months

Genetic casual attributions will be measured using a a 2-item Likert scale that assesses perceived genetic role for weight status and potential for weight loss. This will be completed by adults. Those who endorse completely or mostly for the role of genes in weight loss will be characterized as having "high genetic attribution" for weight status.

Baseline, 3 months, 9 months

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Participation rates and representativeness of enrolled participants
Prazo: 9 months

Reach (participation rates and representativeness) will be assessed across recruitment methods. Participation rates will be calculated in multiple ways to include: 1) the percentage of individuals on lists who respond and 2) the percentage of eligible respondents who enroll. Enrolled participants will be classified by recruitment method according to participant self-report of how they heard about the study,. Representativeness will be assessed by comparing demographics (age/grade, sex, race/ethnicity, BMI where available) between enrolled participants and non-participants including 1) potential participants on recruitment lists and 2) those who are screened but do not enroll. In addition, the investigators will assess the impact of nurse engagement/leadership on participant reach and attendance.

9 months
Physical activity
Prazo: Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months

Self-reported physical activity will be collected from the exercise vital sign. A subset of participants will have physical activity measured using a study-provided Garmin activity device, a consumer wearable that will automatically detect and track activity such as walking, running, and cycling. This device will measures steps.

Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months
Child diet
Prazo: Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months

Child diet will be parent reported using the Children's Eating Habits Questionnaire-Food Frequency Questionnaire section (CEHQ-FFQ). We are interested in the frequency of red foods ("junk" foods) and fruits/vegetables. A subset of participants will complete this more frequently beginning at 13 weeks.

Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Ann M Davis, PhD, MPH, ABPP, University of Kansas Medical Center
  • Investigador principal: Christie Befort, PhD, University of Kansas Medical Center

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

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)

23 de outubro de 2023

Conclusão Primária (Real)

14 de setembro de 2026

Conclusão do estudo (Real)

14 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

1 de novembro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de novembro de 2022

Primeira postagem (Real)

14 de novembro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

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

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