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Formative Research - Developing a Family-based Obesity Prevention Intervention in the Canadian Context

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Parents and Tots Together Program
Supervision for Safety
Sponsored by
University of Guelph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

2 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • We will consider eligible all parents who have a child age 2-5 years.

Exclusion Criteria:

  • We will exclude: 1) any families who plan to move out of the area during the 9-month study period; and 2) children with severe health conditions that would prohibit them from participating in study activities.

Sites / Locations

  • University of Guelph

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Parents and Tots Together Program

Arm Description

9-week parenting group focused on safety

Parents and Tots Together Program is a 9-week, group-based parenting intervention

Outcomes

Primary Outcome Measures

Child change in body mass index (BMI), standardized to age and gender.

Secondary Outcome Measures

Change in child sleep duration
Change in child physical activity
Change in child intake of sugar-sweetened beverages
Change in child Television/video viewing
Change in parent feeding behaviours

Full Information

First Posted
October 21, 2013
Last Updated
January 3, 2017
Sponsor
University of Guelph
Collaborators
Danone Institute International
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1. Study Identification

Unique Protocol Identification Number
NCT02222571
Brief Title
Formative Research - Developing a Family-based Obesity Prevention Intervention in the Canadian Context
Official Title
Formative Research - Developing a Family-based Obesity Prevention Intervention in the Canadian Context
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph
Collaborators
Danone Institute International

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This formative research shows that parents of preschool-aged children are enthusiastic about learning general parenting skills, such as discipline strategies, but that they are less interested in information on child nutrition and physical activity needs. To capitalize on this enthusiasm, Dr. Haines developed Parents and Tots Together (PTT), an intervention that embeds strategies to improve children's nutrition and activity behaviours within an existing general skills parenting program. Results from the investigators feasibility trial with 16 Boston-area parents show that PTT is feasible for implementation and is extremely well-received by parents. Results are also encouraging with respect to changing parent feeding behaviours and children's nutrition and activity behaviours. What is not known is whether this program is feasible and contextually appropriate for Canadian families. Thus, the next step in this research program, and the overall goal of this study, is to assess Parents and Tots Together (PTT), a family-based intervention to prevent obesity among children 3 to 5 years of age, within the Canadian context. To achieve this goal, the investigators will conduct a pilot trial of the PTT program with 60 families recruited through Ontario Early Years Centres (OEYC). The investigators will randomize 30 families to the 3-month PTT intervention and 30 to a control condition. The investigators primary objective is to implement and test the feasibility and acceptability of PTT among families with preschool children so appropriate revisions can be made to adapt it to a Canadian context. The investigators secondary objective is to compare the following outcomes among intervention versus control participants: Parent weight-related behaviours (i.e., parent physical activity, intake of sugar-sweetened beverages, and television/video viewing, as well as responsiveness to child satiety cues). General parenting behaviours (i.e., use of positive discipline strategies). Child weight-related behaviours (i.e., sleep duration, physical activity, intake of sugar-sweetened beverages, television/video viewing). Nutritional risk score based on a screening tool for preschoolers. Child change in body mass index (BMI), standardized to age and gender.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
9-week parenting group focused on safety
Arm Title
Parents and Tots Together Program
Arm Type
Experimental
Arm Description
Parents and Tots Together Program is a 9-week, group-based parenting intervention
Intervention Type
Behavioral
Intervention Name(s)
Parents and Tots Together Program
Intervention Description
Group-based parenting program, 9 weeks delivered in a community setting
Intervention Type
Behavioral
Intervention Name(s)
Supervision for Safety
Intervention Description
group-based safety intervention for parents
Primary Outcome Measure Information:
Title
Child change in body mass index (BMI), standardized to age and gender.
Time Frame
baseline, 6 month follow-up
Secondary Outcome Measure Information:
Title
Change in child sleep duration
Time Frame
baseline, 6-month follow-up
Title
Change in child physical activity
Time Frame
baseline, 6-month follow-up
Title
Change in child intake of sugar-sweetened beverages
Time Frame
baseline, 6-month follow-up
Title
Change in child Television/video viewing
Time Frame
baseline, 6-months
Title
Change in parent feeding behaviours
Time Frame
baseline, 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: We will consider eligible all parents who have a child age 2-5 years. Exclusion Criteria: We will exclude: 1) any families who plan to move out of the area during the 9-month study period; and 2) children 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
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Guelph
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G 2W1
Country
Canada

12. IPD Sharing Statement

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Formative Research - Developing a Family-based Obesity Prevention Intervention in the Canadian Context

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