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Families Improving Together (FIT) for Weight Loss

18 de abril de 2019 actualizado por: Dawn Wilson, University of South Carolina
The increasing rate of obesity has become a major public health concern with national reports indicating 40% of African American adolescents are now overweight/obese. Little is known about effective weight loss interventions in ethnic minority adolescents. However, research has shown that ethnic minorities attend fewer intervention sessions, have higher attrition rates and lose less weight compared to Caucasians. Two fundamental problems related to this lack of progress are 1) lack of appropriate content of weight loss interventions for African American adolescents that integrate cultural issues, parenting skills, and motivational strategies for long-term change and, 2) poor dose of weight loss interventions because of participant fatigue and drop out. While previous weight loss studies for adolescents have been long lasting (12-25 weeks), our team developed a weight loss program that is a relatively brief (8-week) face-to-face intervention that integrates motivational (autonomy-support) and positive parenting skills (monitoring, social support, positive communication skills) for reducing z-BMI in overweight African American adolescents. Our team recently conducted a pilot study testing the feasibility of an 8-week on-line culturally tailored intervention, Thus, the goal of this project is to conduct a randomized controlled efficacy trial to address the problems with past studies by 1) making the face-to-face group intervention shorter, 2) using an on-line component to compliment the group-based intervention for increasing dose, and by 3) tailoring a motivational and parenting skills program directly to parents and adolescents skill levels and cultural background. 520 overweight African American adolescents and their parents will be recruited to participate. Phase I of the trial will test the efficacy of an 8-week face-to-face group randomized trial comparing motivational plus family-based weight loss (M+FWL) to a basic health (BH) education program on reducing z-BMI and improving diet and physical activity (PA) in overweight African American adolescents. In phase II of the trial participants will be re-randomized to either an 8-week on-line intervention or a control on-line program resulting in a 2 (M+FWL vs. BH group) x 2 (intervention vs. control on-line program) factorial design. A 6-month follow-up will examine whether adolescents in the 8-week M+FWL group plus 8-week on-line intervention program will show the greatest maintenance in reducing z-BMI.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

241

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

    • South Carolina
      • Columbia, South Carolina, Estados Unidos, 29201
        • Obesity Research Group

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

11 años a 16 años (Niño)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Must have a parent or primary caregiver who lives in the same house as the adolescent
  • Live within 60 miles of the program's office
  • Have at least 3 grandparents who are African American
  • Access to the internet
  • Children between the ages of 11 and 16
  • Child must have BMI above 85th percentile and below 99th percentile
  • Have no medical condition that would limit participation in moderate intensity exercise including life-threatening illness (e.g., immobile, severely disabled, or bed ridden)
  • Available and able to participate in measures and intervention activities over the next year

Exclusion Criteria:

  • Adolescents with chronic illness
  • Adolescents who require a specialized diet may not be eligible
  • Developmental delay
  • Partaking currently in another weight loss program

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 factorial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Mot. & Fam. Weight Loss + Online Interv.
Participants are randomized to motivational and family weight loss program plus the online intervention.
This group will receive the comprehensive motivational and family weight loss intervention.
Participants will receive the online tailored weight loss intervention program after they have either received the motivational plus family weight loss program or basic health face-to-face program.
Experimental: Mot. & Fam. Weight Loss + Online Control
Participants are randomized to motivational and family weight loss intervention and then the online control program.
This group will receive the comprehensive motivational and family weight loss intervention.
Participants will receive the online control program after they have either received the motivational plus family weight loss program or the basic health education program.
Experimental: Basic Health Educ. & Online Interv.
Participants are randomized to the basic health education program and then the online intervention program.
Participants will receive the online tailored weight loss intervention program after they have either received the motivational plus family weight loss program or basic health face-to-face program.
This group will receive the comprehensive basic health education intervention.
Comparador activo: Basic Health Educ. & Online Control
Participants are randomized to the basic health education program and then to the online control program.
Participants will receive the online control program after they have either received the motivational plus family weight loss program or the basic health education program.
This group will receive the comprehensive basic health education intervention.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Body Mass Index (z-BMI) in Adolescents
Periodo de tiempo: Baseline to 2 months
We are investigating whether there is change in body mass index (BMI; age- and sex-adjusted based upon CDC norms) from baseline to 2 months and whether there are group differences (i.e., M+FWL vs. BH groups) in change in BMI in adolescents.
Baseline to 2 months
Change in Body Mass Index (z-BMI) in Adolescents
Periodo de tiempo: Baseline to 4 months
We are investigating whether there is change in body mass index (BMI; age- and sex-adjusted based upon CDC norms) from baseline to 4 months and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in BMI in adolescents.
Baseline to 4 months
Change in Body Mass Index (z-BMI) in Adolescents
Periodo de tiempo: Baseline to 6-month follow-up
We are investigating intervention effects on change in body mass index (BMI; age- and sex-adjusted based upon CDC norms) from baseline to 6 months post-intervention. Specifically, we will examine whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in maintenance in BMI in adolescents.
Baseline to 6-month follow-up

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Moderate to Vigorous Physical Activity (MVPA) in Parents and Adolescents
Periodo de tiempo: Baseline to 4 months
Minutes per day; We are investigating whether there is change of physical activity from baseline to 4 months and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in MVPA in parents and adolescents.
Baseline to 4 months
Change of 24 Hour Dietary Recall (NDRS) of Kcals in Parents and Adolescents
Periodo de tiempo: Baseline to 4 months
We are investigating whether there is change of Kcals at 4 months. We are looking at these effects for fruit and vegetable intake, as well as total fat intake and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in diet in parents and adolescents.
Baseline to 4 months
Change in Psychosocial Variables in Adolescents
Periodo de tiempo: Baseline to 4 months
Examine the effects of psychosocial variables (autonomy-support, monitoring, communication) as potential mediators of the intervention effects on changes in z-BMI, dietary intake, and MVPA in adolescents.
Baseline to 4 months
Change in Moderate to Vigorous Physical Activity in Adolescents
Periodo de tiempo: Baseline to 6-month Follow-up
Minutes per day; We are investigating whether there is change of physical activity at the 6-month follow-up and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in MVPA in adolescents.
Baseline to 6-month Follow-up
Change of 24 Hour Dietary Recall (NDRS) of Kcals in Adolescents
Periodo de tiempo: Baseline to 6-month Follow-up
We are investigating whether there is change of Kcals at 6-month follow-up. We are specifically looking at effects for fruit and vegetable intake, as well as total fat intake in adolescents, and vegetable intake, as well as total fat intake and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in diet in adolescents.
Baseline to 6-month Follow-up
Change in Body Mass Index (z-BMI) in Parents
Periodo de tiempo: Baseline to 4 months
We are investigating whether there is change in body mass index (BMI; age- and sex-adjusted based upon CDC norms) from baseline to 4 months and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in BMI in parents.
Baseline to 4 months
Change in Body Mass Index (z-BMI) for Parents
Periodo de tiempo: Baseline to 6 Months Follow-up
We are investigating whether there is change in body mass index (BMI; age- and sex-adjusted based upon CDC norms) from baseline to 6 months and whether there are group differences (i.e., M+FWL & Intervention online, M+FWL & Control online, BH & Intervention online, BH & Control online) in change in BMI in parents.
Baseline to 6 Months Follow-up

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Dawn K Wilson, PhD, University of South Carolina

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.

Publicaciones Generales

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

1 de julio de 2012

Finalización primaria (Actual)

8 de marzo de 2019

Finalización del estudio (Actual)

8 de marzo de 2019

Fechas de registro del estudio

Enviado por primera vez

22 de enero de 2013

Primero enviado que cumplió con los criterios de control de calidad

18 de febrero de 2013

Publicado por primera vez (Estimar)

21 de febrero de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de abril de 2019

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

18 de abril de 2019

Última verificación

1 de abril de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Pro00016136
  • R01HD072153 (Subvención/contrato del NIH de EE. UU.)

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. .

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