- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02222766
Parents and Tots Together: A Family-Based Obesity Prevention Intervention (PTT)
Parents and Tots Together: A Family-Based Intervention to Promote Healthy Eating and Activity Behaviors Among Preschool Children
The obesity epidemic has spared no age group, including our youngest children. My and others' formative research shows that ethnically-diverse, low-income parents of young children are enthusiastic about learning general parenting skills, such as discipline strategies, but less interested in nutrition and physical activity. To capitalize on this enthusiasm, I will create and test an intervention that embeds strategies to improve child weight-related behaviors within a general skills parenting program.
The overall goal of this study is to assess Parents and Tots Together (PTT), a family-based intervention to prevent obesity among children age 2 through 5 years. To achieve this goal, my colleagues and I will conduct a randomized controlled trial (RCT) among ethnically diverse, primarily low-income families. Our specific aims are to:
- Determine the extent to which the intervention, compared with a control condition, results in a smaller age-associated increase in body mass index (BMI) among children after a 3- month intervention and a 9-month follow-up period (primary outcome).
Determine the extent to which the intervention, compared with a control condition, results in:
- Improved parent general parenting behaviors, i.e., increased use of positive discipline strategies.
- Improved parent feeding practices, i.e., increased responsiveness to child satiety cues.
- Improved child weight-related behaviors, i.e., increased sleep duration and physical activity, and reduced sugar-sweetened beverage intake and television/video viewing.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02215
- Harvard Pilgrim Health Care
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- parents who have a child aged 2-5 years
- respond to interviews and questionnaires in English or Spanish
Exclusion Criteria:
- any families who plan to move during the study period
- children or parents with severe health conditions that would prohibit them from participating in study activities
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Parents and Tots Together Program
9-week group-based parenting program
|
Group-based parenting program, 9 sessions offered weekly
|
|
Aktiv komparator: Control
Minimal attention control- weekly mailed information on general child development for 9 weeks
|
Minimal attention control- 9 weekly mailed information on general child development
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in body mass index (BMI), adjusted for age and gender
Tidsramme: baseline, post-intervention, 9-month follow-up
|
baseline, post-intervention, 9-month follow-up
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in parent general parenting behaviors, i.e., use of positive discipline strategies.
Tidsramme: baseline, post-intervention, 9-month follow-up
|
baseline, post-intervention, 9-month follow-up
|
|
Change in child weight-related behaviors, i.e., sleep duration and physical activity, and sugar-sweetened beverage intake and television/video viewing.
Tidsramme: baseline, post-intervention, 9-month follow-up
|
baseline, post-intervention, 9-month follow-up
|
|
Change in parental feeding behaviors, i.e., controlling feeding practices
Tidsramme: baseline, post-intervention, 9-month follow-up
|
baseline, post-intervention, 9-month follow-up
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 190331-41
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