- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Harvard Pilgrim Health Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Parents and Tots Together Program
9-week group-based parenting program
|
Group-based parenting program, 9 sessions offered weekly
|
|
Active Comparator: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in body mass index (BMI), adjusted for age and gender
Time Frame: baseline, post-intervention, 9-month follow-up
|
baseline, post-intervention, 9-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in parent general parenting behaviors, i.e., use of positive discipline strategies.
Time Frame: 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.
Time Frame: baseline, post-intervention, 9-month follow-up
|
baseline, post-intervention, 9-month follow-up
|
|
Change in parental feeding behaviors, i.e., controlling feeding practices
Time Frame: baseline, post-intervention, 9-month follow-up
|
baseline, post-intervention, 9-month follow-up
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 190331-41
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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