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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02222571
• Other study ID #: 12JL030
• Status: Completed
• Phase: N/A
• First received: October 21, 2013
• Last updated: January 3, 2017
• Start date: July 2013
• Est. completion date: October 2014

Study information

• Verified date: January 2017
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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:

1. 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).

2. General parenting behaviours (i.e., use of positive discipline strategies).

3. Child weight-related behaviours (i.e., sleep duration, physical activity, intake of sugar-sweetened beverages, television/video viewing).

4. Nutritional risk score based on a screening tool for preschoolers.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Parents and Tots Together Program
Group-based parenting program, 9 weeks delivered in a community setting
• Supervision for Safety
group-based safety intervention for parents

Locations

Country	Name	City	State
Canada	University of Guelph	Guelph	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Guelph	Danone Institute International

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child change in body mass index (BMI), standardized to age and gender.		baseline, 6 month follow-up	No
Secondary	Change in child sleep duration		baseline, 6-month follow-up	No
Secondary	Change in child physical activity		baseline, 6-month follow-up	No
Secondary	Change in child intake of sugar-sweetened beverages		baseline, 6-month follow-up	No
Secondary	Change in child Television/video viewing		baseline, 6-months	No
Secondary	Change in parent feeding behaviours		baseline, 6-months	No