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Completed

NCT Number: NCT02222571

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

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.

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Key information

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parents and Tots Together Program

Behavioral

Group-based parenting program, 9 weeks delivered in a community setting

Supervision for Safety

Behavioral

group-based safety intervention for parents

Primary outcomes

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

    Time frame: baseline, 6 month follow-up

Secondary outcomes

  1. Change in child sleep duration

    Time frame: baseline, 6-month follow-up

  2. Change in child physical activity

    Time frame: baseline, 6-month follow-up

  3. Change in child intake of sugar-sweetened beverages

    Time frame: baseline, 6-month follow-up

  4. Change in child Television/video viewing

    Time frame: baseline, 6-months

  5. Change in parent feeding behaviours

    Time frame: baseline, 6-months

Sponsors and collaborators

Lead sponsor

University of Guelph

Other

Collaborators

  • Danone Institute International

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 21, 2014
Registry last updated
Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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