Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

iAmHealthy Parents First: un programa de televideo sobre obesidad para padres e hijos para familias en zonas rurales de Kansas

29 de septiembre de 2026 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

410

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

6 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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 activo: 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.

Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percent weight change in parents and BMIz (BMI z-score) in children
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mediator: Attendance
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Participation rates and representativeness of enrolled participants
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

23 de octubre de 2023

Finalización primaria (Actual)

14 de septiembre de 2026

Finalización del estudio (Actual)

14 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

1 de noviembre de 2022

Primero enviado que cumplió con los criterios de control de calidad

8 de noviembre de 2022

Publicado por primera vez (Actual)

14 de noviembre de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • STUDY00147611
  • R01NR019810 (Subvención/contrato del NIH de EE. UU.)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .