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

NCT01698606 | Terminated

• 1 other identifier: 103011
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Obesity

Keywords

childhood obesity; multidisciplinary; preschool children; community-based; lifestyle intervention; family-centered

Outcome Measures

Primary Outcomes (1)

• BMI z-score

  Change in BMI z-score

  Baseline, 3, 6, 9, 12 months

Secondary Outcomes (8)

• Change in Quality of Life Scores (PedsQL 4.0)

  Baseline, 3, 6, 9, 12 months

• Change in physical activity score (Netherlands Physical Activity Questionnaire for Young Children, NPAQ)

  Baseline, 3, 6, 9, 12 months

• Change in parent-reported daily screen-time (TV, computer)

  Baseline, 3, 6, 9, 12 months

• Change in fruit & vegetable consumption assessed by 3-day food records

  Baseline, 3, 6, 9, 12 months

• Change in dairy-product consumption assessed by 3-day food records

  Baseline, 3, 6, 9, 12 months

Other Outcomes (1)

• Change in parental BMI (kg/m2)

  Baseline, 3, 6, 9, 12 months

Study Arms (2)

Secondary lifestyle intervention arm

ACTIVE COMPARATOR

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.

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

Primary lifestyle intervention arm

EXPERIMENTAL

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

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

Interventions

Multidisciplinary, family-centered lifestyle intervention with behavioral counseling BEHAVIORAL

Parent/caregiver education with skill training and practical activities revolving around healthy dietary choices, establishing an active versus a sedentary lifestyle, and behavioral aspects, while children will be engaged in active play.

Primary lifestyle intervention arm; Secondary lifestyle intervention arm

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Children's Hospital, London Health Sciences Centre, University of Western Ontario

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dirk E. Bock, M.D.

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 3, 2012
• Study Start: January 1, 2013
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

CA (1)