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

4 maggio 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

277

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • University of Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • University of Maryland, School of Medicine

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Maternal Physical Activity and Nutrition
A maternal intervention focusing on healthy diet and physical activity patterns for mothers.
Comportamentale: 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.
Sperimentale: Parenting
A toddler parenting intervention focusing on parenting, limit setting, and development strategies.
Comportamentale: 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.
Sperimentale: Child Safety
Attention control group. The parents received intervention to promote safety among toddlers.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change of Body Mass Index (BMI) Z-score for Toddlers
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change of Diet Quality for Toddlers
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Maryland, Baltimore

Collaboratori

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

Investigatori

  • Investigatore principale: Maureen M Black, PhD, University of Maryland, College Park

Pubblicazioni e link utili

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Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2006

Completamento primario (Effettivo)

1 settembre 2013

Completamento dello studio (Effettivo)

1 maggio 2014

Date di iscrizione allo studio

Primo inviato

11 febbraio 2013

Primo inviato che soddisfa i criteri di controllo qualità

23 novembre 2015

Primo Inserito (Stima)

26 novembre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 maggio 2020

Ultimo verificato

1 maggio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • H-27980
  • R01HD056099 (Sovvenzione/contratto NIH degli Stati Uniti)
  • R03HD077156 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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