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

NCT ID: NCT02222766

Last Updated: 2014-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-10-31

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:

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Parents and Tots Together Program

9-week group-based parenting program

Group Type: EXPERIMENTAL

Parents and Tots Together Program

Intervention Type: BEHAVIORAL

Group-based parenting program, 9 sessions offered weekly

Control

Minimal attention control- weekly mailed information on general child development for 9 weeks

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Minimal attention control- 9 weekly mailed information on general child development

Interventions

Parents and Tots Together Program

Group-based parenting program, 9 sessions offered weekly

Intervention Type: BEHAVIORAL

Control

Minimal attention control- 9 weekly mailed information on general child development

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University of Guelph

OTHER

Sponsor Role: lead

Responsible Party

Jess Haines

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jess Haines, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guelph

Locations

Harvard Pilgrim Health Care

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

190331-41

Identifier Type: -

Identifier Source: org_study_id