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

NCT02222766 | Completed

• 1 other identifier: 190331-41
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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. 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. 2.Determine the extent to which the intervention, compared with a control condition, results in:
3. 3.Improved parent general parenting behaviors, i.e., increased use of positive discipline strategies.
4. 4.Improved parent feeding practices, i.e., increased responsiveness to child satiety cues.
5. 5.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

Outcome Measures

Primary Outcomes (1)

• Change in body mass index (BMI), adjusted for age and gender

  baseline, post-intervention, 9-month follow-up

Secondary Outcomes (3)

• 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

Study Arms (2)

Parents and Tots Together Program

EXPERIMENTAL

9-week group-based parenting program

Behavioral: Parents and Tots Together Program

Control

ACTIVE COMPARATOR

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

Behavioral: Control

Interventions

Parents and Tots Together Program BEHAVIORAL

Group-based parenting program, 9 sessions offered weekly

Parents and Tots Together Program

Control BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• parents who have a child aged 2-5 years
• respond to interviews and questionnaires in English or Spanish

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guelph: lead
• American Heart Association: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Harvard Pilgrim Health Care

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jess Haines, PhD

  University of Guelph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 21, 2014
• Study Start: June 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: August 21, 2014

Record last verified: 2014-08

Locations

US (1)