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

This study is currently recruiting participants.
Verified February 2014 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Dirk Bock, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01698606
First received: October 1, 2012
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

Following an initial small-scale (phase 1) feasibility study, the aim of this pilot study (phase 2) is to investigate whether a community-based, 6-month intervention for overweight and obese preschool children 2-5 years of age and their families, referred by their family physicians, will be successful in reducing the participants' degree of overweight (BMI z-score).

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). Participants will receive an additional free 6-month YMCA membership while participating in the study.


Condition Intervention
Childhood Obesity
Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FOR HEALTH: A Family-ORiented Healthy Eating, Activity and Lifestyle Training With Hands-on Experience for Overweight and Obese Preschool Children and Their Families - a Pilot Trial.

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • BMI z-score [ Time Frame: Baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Change in BMI z-score


Secondary Outcome Measures:
  • Change in Quality of Life Scores (PedsQL 4.0) [ Time Frame: Baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Instrument used: PedsQL 4.0 Generic Core Scales, parent report, for toddlers (age 2-4), or for young children (age 5-6).

  • Change in physical activity score (Netherlands Physical Activity Questionnaire for Young Children, NPAQ) [ Time Frame: Baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Change in parent-reported daily screen-time (TV, computer) [ Time Frame: Baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Parent-reported daily screen-time, estimated to the nearest 15 minutes.

  • Change in fruit & vegetable consumption assessed by 3-day food records [ Time Frame: Baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Change in dairy-product consumption assessed by 3-day food records [ Time Frame: Baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Change in grain-product consumption assessed by 3-day food records [ Time Frame: Baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Change in consumption of sugar-sweetened beverages assessed by 3-day food records [ Time Frame: Baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Change in percent overBMI [ Time Frame: Baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Percent overBMI is the percentage above the 50th percentile of BMI for the respective age and gender [(BMI-BMI at 50th percentile)]/BMI at 50th percentile]*100


Other Outcome Measures:
  • Change in parental BMI (kg/m2) [ Time Frame: Baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
    Assessment of change in BMI of the caregiver primary attending the intervention with the child.


Estimated Enrollment: 28
Study Start Date: January 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Secondary lifestyle intervention arm
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
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.
Experimental: Primary lifestyle intervention arm
First arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling
Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling
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.

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged 2-5 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698606

Contacts
Contact: Laura Beamish, BSc 519-685-8500 ext 56816

Locations
Canada, Ontario
Children's Hospital, London Health Sciences Centre, University of Western Ontario Recruiting
London, Ontario, Canada, N6A 5W9
Principal Investigator: Dirk E. Bock, M.D.         
Principal Investigator: Piotr Wilk, PhD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Dirk E. Bock, M.D. University of Western Ontario, Canada
Principal Investigator: Piotr Wilk, PhD University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Dirk Bock, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01698606     History of Changes
Other Study ID Numbers: 103011
Study First Received: October 1, 2012
Last Updated: February 25, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
childhood obesity
multidisciplinary
preschool children
community-based
lifestyle intervention
family-centered

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014