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

August 20, 2014 updated by: Jess Haines, University of Guelph

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:

  1. 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).

  2. Determine the extent to which the intervention, compared with a control condition, results in:

    1. Improved parent general parenting behaviors, i.e., increased use of positive discipline strategies.
    2. Improved parent feeding practices, i.e., increased responsiveness to child satiety cues.
    3. 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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Harvard Pilgrim Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Behavioral: Parents and Tots Together 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
Behavioral: Control
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

This is where you will find people and organizations involved with this study.

Sponsor

University of Guelph

Collaborators

Harvard Medical School (HMS and HSDM)
Johns Hopkins University
American Heart Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 20, 2014

First Posted (Estimate)

August 21, 2014

Study Record Updates

Last Update Posted (Estimate)

August 21, 2014

Last Update Submitted That Met QC Criteria

August 20, 2014

Last Verified

August 1, 2014

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.

Subscribe