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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pediatric Obesity
Body Weight
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014