FOR HEALTH: A Family-oriented Healthy Eating, Activity and Lifestyle Intervention for Overweight Preschool Children

Lawson Health Research Institute

Status: Terminated

Conditions: Childhood Obesity

Treatments: Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01698606

103011

Details and patient eligibility

About

In this 3-phase study, following an initial small-scale (phase 1) feasibility trial, the aim of phase 2 of the project is to investigate whether a community-based, 12-month intervention for overweight and obese preschool children 2-6 years of age and their families will be effective in reducing the participants' degree of overweight (BMI z-score) and in improving quality of life.

In the final phase (phase 3), participating children will be randomized to either receiving a multidisciplinary lifestyle intervention during the first 6 months (treatment arm), or 6 months later (control or wait list arm), in order to generate more robust effectiveness data. Participants will receive an additional free 6-month YMCA membership while participating in the study.

Enrollment: 11 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged 2-6 on study entry with primary overweight or obesity, BMI => 85th percentile for age and sex on 2010 WHO Growth Charts for Canada
• Family meets Readiness for change criteria, contemplation or higher stage, according to Prochaskas Transtheoretical Model.
• At least one parent/caregiver committed to attend all the program sessions with the child
• Parent/caregiver is agreeing to complete the study questionnaires at the required time points

Exclusion criteria

• Chronic medical conditions potentially impacting program participation or associated with a potentially increased risk in participation (e.g. type 1 diabetes mellitus, heart-, gastrointestinal-, or kidney diseases, uncontrolled asthma, other physical, developmental or psychological disabilities that could limit extent of study participation
• Regular use of medications that could limit extent of study participation
• Other concurrent or recently (last 12 months)received obesity treatment
• Inability to read, speak, and/or verbally understand English
• Living outside of the greater London, Ontario, area

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Secondary lifestyle intervention arm

Active Comparator group

Description:

6-month wait list group. Second arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling, following of completion of main 6-month intervention for arm 1.

Treatment:

Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling

Primary lifestyle intervention arm

Experimental group

Description:

First arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling

Treatment:

Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling