Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

October 1, 2012
February 25, 2014
January 2013
April 2015   (final data collection date for primary outcome measure)
BMI z-score [ Time Frame: Baseline, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
Change in BMI z-score
Same as current
Complete list of historical versions of study NCT01698606 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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.
Same as current
 
FOR HEALTH: A Family-oriented Healthy Eating, Activity and Lifestyle Intervention for Overweight Preschool Children
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Childhood Obesity
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.
  • 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.
    Intervention: Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling
  • Experimental: Primary lifestyle intervention arm
    First arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling
    Intervention: Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
28
November 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
2 Years to 5 Years
No
Contact: Laura Beamish, BSc 519-685-8500 ext 56816
Canada
 
NCT01698606
103011
No
Dirk Bock, Lawson Health Research Institute
Lawson Health Research Institute
Not Provided
Principal Investigator: Dirk E. Bock, M.D. University of Western Ontario, Canada
Principal Investigator: Piotr Wilk, PhD University of Western Ontario, Canada
Lawson Health Research Institute
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP