Toddler Overweight Prevention Study Among Low-Income Families (TOPS)
Toddler Overweight Prevention: Comparison of Maternal and Toddler Intervention
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background:
Overweight is a serious public health problem which can begin in early childhood. Factors which contribute to overweight include: overfeeding, excessive intakes of fat and sugar; frequent sedentary activities (i.e. television watching).
Overweight, defined as a BMI > 95th percentile, in early childhood has reached epidemic proportions with 14% of 2-5 year olds overweight and 26.2% "at risk of overweight," defined as a BMI > 85th percentile (Ogden et al., 2006).
Dietary and physical activity patterns established early in life track over time, making the first few years of life an ideal time to help families establish healthy eating and physical activity behaviors and avoid overweight. This project works to identify techniques that could prevent overweight.
Purpose of Study:
The investigators are collaborating with the Anne Arundel County, MD Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and the University of Maryland's Pediatric Ambulatory Center to implement strategies that will prevent overweight among toddlers. The project focuses on the dietary, physical activity, and growth patterns of WIC toddlers. The investigators are conducting a 3-cell randomized trial consisting of: 1) a maternal intervention focusing on healthy diet and physical activity patterns for mothers; 2) a toddler parenting intervention focusing on parenting, limit setting, and development strategies; and 3) an intervention on child safety. The interventions are implemented over 3 months, with 8 sessions.
The investigators hypothesize that altering maternal behavior will have a positive impact on the growth and development of the toddler by preventing behaviors that lead to overweight among children. The parenting intervention will improve parenting skills by offering information on proper approaches to feeding, discipline and educational play. The investigators will compare the growth patterns of toddlers whose mothers were randomized to the maternal and parenting interventions with those in the safety intervention. This study design allows us to examine the mechanisms linking the interventions to improvements in diet, physical activity, and growth.
In addition, the investigators will conduct the safety promotion intervention for the attention control group, considering the high risk of unintentional injuries among the toddlers from low-income families. The investigators also hypothesize that the safety promotion intervention will reduce the safety problems of the toddlers' homes. The underlying mechanisms will be examined, if there is a significant intervention effect.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland
-
Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland, School of Medicine
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- At least 18 yrs old
- Has child between 12-32 months
- Child able to walk
- Birth weight of child at least 5lbs. 8oz.
Exclusion Criteria:
- Mom cannot be pregnant
- No known congenital problems or disabilities
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Maternal Physical Activity and Nutrition
A maternal intervention focusing on healthy diet and physical activity patterns for mothers.
|
At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake).
They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary.
Mothers will be given pedometers and shown how to keep a pedometer tracking chart.
As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.
|
|
Experimental: Parenting
A toddler parenting intervention focusing on parenting, limit setting, and development strategies.
|
Behavior and Development Related to Diet and Physical Activity.
The toddler parenting intervention will include modules on toddler behavior and development.
We will devote sessions to topics involving parenting toddlers, limit setting, and child development.
|
|
Experimental: Child Safety
Attention control group.
The parents received intervention to promote safety among toddlers.
|
The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention.
Participants will set weekly child safety goals.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change of Body Mass Index (BMI) Z-score for Toddlers
Periodo de tiempo: Baseline to 12-month Follow-up
|
Measured weight and height for the toddlers, transferred to age and gender-specific body mass index (BMI) Z-score.
The range of BMI z-score is usually between -5 and +5.
BMI z-score lower than -1.645 is defined as underweight.
The BMI z-score from -1.645 to 1.036 is normal weight and BMI z-score greater or equal to 1.645 is obese.
|
Baseline to 12-month Follow-up
|
|
Change in Body Mass Index (BMI) Score Among Mothers
Periodo de tiempo: Baseline to 12 month Follow-up
|
Change body mass index (BMI, kg/m^2, calculated by measured weight and height) from baseline to 12-month follow-up.
The BMI ranges usually ranges from 0-50 with higher score indicating higher weight regarding the height.
Scores above 25 are considered overweight and scores above 30 are considered obese.
|
Baseline to 12 month Follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change of Diet Quality for Toddlers
Periodo de tiempo: Baseline to 12-month Follow-up
|
Healthy Eating Index 2015 (HEI 2015) based on 24-hr diet recall.
The range is 0-100, with higher scores representing better diet quality.
|
Baseline to 12-month Follow-up
|
|
Change of Diet Quality for Mothers
Periodo de tiempo: Baseline to 12-month Follow-up
|
Healthy Eating Index (HEI 15) is calculated based on 24 hour diet recall.
Scores range from 0-100, with higher scores optimal
|
Baseline to 12-month Follow-up
|
|
Change of Child Physical Activity
Periodo de tiempo: Baseline to 12-month Follow-up
|
Physical activity is measured by wearing an accelerometer for 7 days.
Using standards for toddlers, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity.
|
Baseline to 12-month Follow-up
|
|
Change of Maternal Physical Activity
Periodo de tiempo: Baseline-12 month follow up
|
Physical activity is measured by wearing an accelerometer for 7 days.
Using standards for adults, we count the number of minutes in moderate-vigorous physical activity (MVPA) per day, and averaged over the number of days measured, higher scores mean more physical activity.
|
Baseline-12 month follow up
|
|
Feeding Style
Periodo de tiempo: Baseline to 12 month Follow-up
|
The Emotional Availability Scales (EAS) include 4 maternal scales (sensitivity, structuring, non-intrusiveness, and non-hostile) and 2 child scales (responsiveness and involvement), each rated on 7-point Likert scales, with high scores optimal.
The maternal and child sub-scale scores were averaged for a total mealtime interaction score.
The total score ranges from 1-7.
Coders were trained until they demonstrated inter-rater reliability >0.80 based on intraclass correlation coefficients with 10 observations from the scale creator and 10 observations with the faculty coordinator.
Inter-rater reliability was reviewed through weekly reliability checks.
|
Baseline to 12 month Follow-up
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Maureen M Black, PhD, University of Maryland, College Park
Publicaciones y enlaces útiles
Publicaciones Generales
- Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
- Campbell KL, Wang Y, Kuhn AP, Black MM, Hager ER. An ecological momentary assessment study of physical activity behaviors among mothers of toddlers from low-income households. BMC Womens Health. 2021 Mar 22;21(1):120. doi: 10.1186/s12905-021-01243-2.
- Covington L, Armstrong B, Trude ACB, Black MM. Longitudinal Associations Among Diet Quality, Physical Activity and Sleep Onset Consistency With Body Mass Index z-Score Among Toddlers in Low-income Families. Ann Behav Med. 2021 Jun 28;55(7):653-664. doi: 10.1093/abm/kaaa100.
- Black MM, Hager ER, Wang Y, Hurley KM, Latta LW, Candelaria M, Caulfield LE. Toddler obesity prevention: A two-generation randomized attention-controlled trial. Matern Child Nutr. 2021 Jan;17(1):e13075. doi: 10.1111/mcn.13075. Epub 2020 Sep 4.
- Armstrong B, Covington LB, Hager ER, Black MM. Objective sleep and physical activity using 24-hour ankle-worn accelerometry among toddlers from low-income families. Sleep Health. 2019 Oct;5(5):459-465. doi: 10.1016/j.sleh.2019.04.005. Epub 2019 Jun 3.
- Wang Y, Gielen AC, Magder LS, Hager ER, Black MM. A randomised safety promotion intervention trial among low-income families with toddlers. Inj Prev. 2018 Feb;24(1):41-47. doi: 10.1136/injuryprev-2016-042178. Epub 2017 Apr 6.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- H-27980
- R01HD056099 (Subvención/contrato del NIH de EE. UU.)
- R03HD077156 (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. .