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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01698606
Recruitment Status : Suspended (Phase 1 (Feasibility) completed. Currently no funding to launch Phase 2 (RCT).)
First Posted : October 3, 2012
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : January 2013
Primary Completion Date : December 12, 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. BMI z-score [ Time Frame: Baseline, 3, 6, 9, 12 months ]
    Change in BMI z-score


Secondary Outcome Measures :
  1. Change in Quality of Life Scores (PedsQL 4.0) [ Time Frame: Baseline, 3, 6, 9, 12 months ]
    Instrument used: PedsQL 4.0 Generic Core Scales, parent report, for toddlers (age 2-4), or for young children (age 5-6).

  2. Change in physical activity score (Netherlands Physical Activity Questionnaire for Young Children, NPAQ) [ Time Frame: Baseline, 3, 6, 9, 12 months ]
  3. Change in parent-reported daily screen-time (TV, computer) [ Time Frame: Baseline, 3, 6, 9, 12 months ]
    Parent-reported daily screen-time, estimated to the nearest 15 minutes.

  4. Change in fruit & vegetable consumption assessed by 3-day food records [ Time Frame: Baseline, 3, 6, 9, 12 months ]
  5. Change in dairy-product consumption assessed by 3-day food records [ Time Frame: Baseline, 3, 6, 9, 12 months ]
  6. Change in grain-product consumption assessed by 3-day food records [ Time Frame: Baseline, 3, 6, 9, 12 months ]
  7. Change in consumption of sugar-sweetened beverages assessed by 3-day food records [ Time Frame: Baseline, 3, 6, 9, 12 months ]
  8. Change in percent overBMI [ Time Frame: Baseline, 3, 6, 9, 12 months ]
    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:
  1. Change in parental BMI (kg/m2) [ Time Frame: Baseline, 3, 6, 9, 12 months ]
    Assessment of change in BMI of the caregiver primary attending the intervention with the child.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698606


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

Responsible Party: Dirk Bock, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01698606     History of Changes
Other Study ID Numbers: 103011
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

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

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