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

4. Mai 2020 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

277

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21201
        • University of Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21201
        • University of Maryland, School of Medicine

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Maternal Physical Activity and Nutrition
A maternal intervention focusing on healthy diet and physical activity patterns for mothers.
Verhalten: 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.
Experimental: Parenting
A toddler parenting intervention focusing on parenting, limit setting, and development strategies.
Verhalten: 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.
Experimental: Child Safety
Attention control group. The parents received intervention to promote safety among toddlers.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change of Body Mass Index (BMI) Z-score for Toddlers
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change of Diet Quality for Toddlers
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Maryland, Baltimore

Mitarbeiter

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

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. April 2006

Primärer Abschluss (Tatsächlich)

1. September 2013

Studienabschluss (Tatsächlich)

1. Mai 2014

Studienanmeldedaten

Zuerst eingereicht

11. Februar 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. November 2015

Zuerst gepostet (Schätzen)

26. November 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Mai 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Mai 2020

Zuletzt verifiziert

1. Mai 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • H-27980
  • R01HD056099 (US NIH Stipendium/Vertrag)
  • R03HD077156 (US NIH Stipendium/Vertrag)

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