Parents and Tots Together: A Family-Based Obesity Prevention Intervention (PTT)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parents and Tots Together Program
Control
Sponsored by

About this trial
This is an interventional prevention trial for Obesity
Eligibility Criteria
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
Sites / Locations
- Harvard Pilgrim Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Parents and Tots Together Program
Control
Arm Description
9-week group-based parenting program
Minimal attention control- weekly mailed information on general child development for 9 weeks
Outcomes
Primary Outcome Measures
Change in body mass index (BMI), adjusted for age and gender
Secondary Outcome Measures
Change in parent general parenting behaviors, i.e., use of positive discipline strategies.
Change in child weight-related behaviors, i.e., sleep duration and physical activity, and sugar-sweetened beverage intake and television/video viewing.
Change in parental feeding behaviors, i.e., controlling feeding practices
Full Information
NCT ID
NCT02222766
First Posted
August 20, 2014
Last Updated
August 20, 2014
Sponsor
University of Guelph
Collaborators
American Heart Association, Harvard Medical School (HMS and HSDM), Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT02222766
Brief Title
Parents and Tots Together: A Family-Based Obesity Prevention Intervention
Acronym
PTT
Official Title
Parents and Tots Together: A Family-Based Intervention to Promote Healthy Eating and Activity Behaviors Among Preschool Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph
Collaborators
American Heart Association, Harvard Medical School (HMS and HSDM), Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parents and Tots Together Program
Arm Type
Experimental
Arm Description
9-week group-based parenting program
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Minimal attention control- weekly mailed information on general child development for 9 weeks
Intervention Type
Behavioral
Intervention Name(s)
Parents and Tots Together Program
Intervention Description
Group-based parenting program, 9 sessions offered weekly
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Minimal attention control- 9 weekly mailed information on general child development
Primary Outcome Measure Information:
Title
Change in body mass index (BMI), adjusted for age and gender
Time Frame
baseline, post-intervention, 9-month follow-up
Secondary Outcome Measure Information:
Title
Change in parent general parenting behaviors, i.e., use of positive discipline strategies.
Time Frame
baseline, post-intervention, 9-month follow-up
Title
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
Title
Change in parental feeding behaviors, i.e., controlling feeding practices
Time Frame
baseline, post-intervention, 9-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jess Haines, PhD
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard Pilgrim Health Care
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Parents and Tots Together: A Family-Based Obesity Prevention Intervention
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