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- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02215
- Harvard Pilgrim Health Care
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Parents and Tots Together Program
9-week group-based parenting program
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Group-based parenting program, 9 sessions offered weekly
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Actieve vergelijker: Control
Minimal attention control- weekly mailed information on general child development for 9 weeks
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Minimal attention control- 9 weekly mailed information on general child development
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change in body mass index (BMI), adjusted for age and gender
Tijdsspanne: baseline, post-intervention, 9-month follow-up
|
baseline, post-intervention, 9-month follow-up
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change in parent general parenting behaviors, i.e., use of positive discipline strategies.
Tijdsspanne: 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.
Tijdsspanne: baseline, post-intervention, 9-month follow-up
|
baseline, post-intervention, 9-month follow-up
|
|
Change in parental feeding behaviors, i.e., controlling feeding practices
Tijdsspanne: baseline, post-intervention, 9-month follow-up
|
baseline, post-intervention, 9-month follow-up
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 190331-41
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