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Toddler Overweight Prevention Study Among Low-Income Families (TOPS)

4 mai 2020 mis à jour par: Maureen Black, University of Maryland, Baltimore

Toddler Overweight Prevention: Comparison of Maternal and Toddler Intervention

The hypothesis is that toddlers with parents who are randomized to a parenting intervention and toddlers with parents who are randomized to the maternal intervention focused on maternal diet and physical activity will be more likely to have weight status within normal and to consume a healthy diet and engage in physical activity than toddlers with parents in a placebo (safety) intervention.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

277

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Maryland
      • Baltimore, Maryland, États-Unis, 21201
        • University of Maryland
      • Baltimore, Maryland, États-Unis, 21201
        • University of Maryland, School of Medicine

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Maternal Physical Activity and Nutrition
A maternal intervention focusing on healthy diet and physical activity patterns for mothers.
Comportemental: Maternal Physical Activity and Nutrition
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.
Expérimental: Parenting
A toddler parenting intervention focusing on parenting, limit setting, and development strategies.
Comportemental: Parenting
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.
Expérimental: Child Safety
Attention control group. The parents received intervention to promote safety among toddlers.
Comportemental: Child Safety
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change of Body Mass Index (BMI) Z-score for Toddlers
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change of Diet Quality for Toddlers
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Maryland, Baltimore

Collaborateurs

Johns Hopkins University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Les enquêteurs

  • Chercheur principal: Maureen M Black, PhD, University of Maryland, College Park

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2006

Achèvement primaire (Réel)

1 septembre 2013

Achèvement de l'étude (Réel)

1 mai 2014

Dates d'inscription aux études

Première soumission

11 février 2013

Première soumission répondant aux critères de contrôle qualité

23 novembre 2015

Première publication (Estimation)

26 novembre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 mai 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 mai 2020

Dernière vérification

1 mai 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • H-27980
  • R01HD056099 (Subvention/contrat des NIH des États-Unis)
  • R03HD077156 (Subvention/contrat des NIH des États-Unis)

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