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

NCT02222571 | Completed DMC

• 1 other identifier: 12JL030
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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:

1. 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. 2.General parenting behaviours (i.e., use of positive discipline strategies).
3. 3.Child weight-related behaviours (i.e., sleep duration, physical activity, intake of sugar-sweetened beverages, television/video viewing).
4. 4.Nutritional risk score based on a screening tool for preschoolers.
5. 5.Child change in body mass index (BMI), standardized to age and gender.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

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

  baseline, 6 month follow-up

Secondary Outcomes (5)

• Change in child sleep duration

  baseline, 6-month follow-up

• Change in child physical activity

  baseline, 6-month follow-up

• Change in child intake of sugar-sweetened beverages

  baseline, 6-month follow-up

• Change in child Television/video viewing

  baseline, 6-months

• Change in parent feeding behaviours

  baseline, 6-months

Study Arms (2)

Control

ACTIVE COMPARATOR

9-week parenting group focused on safety

Behavioral: Supervision for Safety

Parents and Tots Together Program

EXPERIMENTAL

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

Behavioral: Parents and Tots Together Program

Interventions

Parents and Tots Together Program BEHAVIORAL

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

Parents and Tots Together Program

Supervision for Safety BEHAVIORAL

group-based safety intervention for parents

Control

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Guelph: lead
• Danone Institute International: collaborator

Study Sites (1)

University of Guelph

Guelph, Ontario, N1G 2W1, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

Organization and Administration; Safety

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Services Administration; Accident Prevention; Accidents; Public Health; Environment and Public Health

Study Officials

• Jess Haines

  University of Guelph

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: August 21, 2014
• Study Start: July 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 5, 2017

Record last verified: 2017-01

Locations

CA (1)