Clinical trial NCT02222766: Parents and Tots Together: A Family-Based Obesity Prevention Intervention
Official title: Parents and Tots Together: A Family-Based Intervention to Promote Healthy Eating and Activity Behaviors Among Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Guelph
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Harvard Medical School (HMS and HSDM)
name: Johns Hopkins University
First posted: 2014-08-21
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change in body mass index (BMI), adjusted for age and gender
timeFrame: baseline, post-intervention, 9-month follow-up
Secondary outcomes:
measure: Change in parent general parenting behaviors, i.e., use of positive discipline strategies.
timeFrame: baseline, post-intervention, 9-month follow-up
measure: Change in child weight-related behaviors, i.e., sleep duration and physical activity, and sugar-sweetened beverage intake and television/video viewing.
timeFrame: baseline, post-intervention, 9-month follow-up
measure: Change in parental feeding behaviors, i.e., controlling feeding practices
timeFrame: baseline, post-intervention, 9-month follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Pilgrim Health Care
state: Massachusetts
Study officials:
affiliation: University of Guelph
name: Jess Haines, PhD
role: PRINCIPAL_INVESTIGATOR
References: