Parents and Tots Together: A Family-Based Obesity Prevention Intervention

Study Overview
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Brief Summary
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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.

Official Title
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Parents and Tots Together: A Family-Based Intervention to Promote Healthy Eating and Activity Behaviors Among Preschool Children

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Parents and Tots Together Program
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parents and Tots Together Program<br>9-week group-based parenting program | Behavioral: Parents and Tots Together Program<br>* Group-based parenting program, 9 sessions offered weekly<br>|
| Active Comparator: Control<br>Minimal attention control- weekly mailed information on general child development for 9 weeks | Behavioral: Control<br>* Minimal attention control- 9 weekly mailed information on general child development<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index (BMI), adjusted for age and gender |  | baseline, post-intervention, 9-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in parent general parenting behaviors, i.e., use of positive discipline strategies. |  | 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. |  | baseline, post-intervention, 9-month follow-up | 
| Change in parental feeding behaviors, i.e., controlling feeding practices |  | baseline, post-intervention, 9-month follow-up |