search
Back to results

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

Primary Purpose

Childhood Obesity

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Multidisciplinary, family-centered lifestyle intervention with behavioral counseling
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring childhood obesity, multidisciplinary, preschool children, community-based, lifestyle intervention, family-centered

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Secondary lifestyle intervention arm

Primary lifestyle intervention arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

BMI z-score
Change in BMI z-score

Secondary Outcome Measures

Change in Quality of Life Scores (PedsQL 4.0)
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)
Change in parent-reported daily screen-time (TV, computer)
Parent-reported daily screen-time, estimated to the nearest 15 minutes.
Change in fruit & vegetable consumption assessed by 3-day food records
Change in dairy-product consumption assessed by 3-day food records
Change in grain-product consumption assessed by 3-day food records
Change in consumption of sugar-sweetened beverages assessed by 3-day food records
Change in percent overBMI
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

Full Information

First Posted
October 1, 2012
Last Updated
May 24, 2019
Sponsor
Lawson Health Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT01698606
Brief Title
FOR HEALTH: A Family-oriented Healthy Eating, Activity and Lifestyle Intervention for Overweight Preschool Children
Acronym
FOR HEALTH
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 Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Phase 1 (Feasibility) completed. Currently no funding to launch Phase 2 (RCT).
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
childhood obesity, multidisciplinary, preschool children, community-based, lifestyle intervention, family-centered

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Secondary lifestyle intervention arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Primary lifestyle intervention arm
Arm Type
Experimental
Arm Description
First arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling
Intervention Type
Behavioral
Intervention Name(s)
Multidisciplinary, family-centered lifestyle intervention with behavioral counseling
Intervention Description
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 Outcome Measure Information:
Title
BMI z-score
Description
Change in BMI z-score
Time Frame
Baseline, 3, 6, 9, 12 months
Secondary Outcome Measure Information:
Title
Change in Quality of Life Scores (PedsQL 4.0)
Description
Instrument used: PedsQL 4.0 Generic Core Scales, parent report, for toddlers (age 2-4), or for young children (age 5-6).
Time Frame
Baseline, 3, 6, 9, 12 months
Title
Change in physical activity score (Netherlands Physical Activity Questionnaire for Young Children, NPAQ)
Time Frame
Baseline, 3, 6, 9, 12 months
Title
Change in parent-reported daily screen-time (TV, computer)
Description
Parent-reported daily screen-time, estimated to the nearest 15 minutes.
Time Frame
Baseline, 3, 6, 9, 12 months
Title
Change in fruit & vegetable consumption assessed by 3-day food records
Time Frame
Baseline, 3, 6, 9, 12 months
Title
Change in dairy-product consumption assessed by 3-day food records
Time Frame
Baseline, 3, 6, 9, 12 months
Title
Change in grain-product consumption assessed by 3-day food records
Time Frame
Baseline, 3, 6, 9, 12 months
Title
Change in consumption of sugar-sweetened beverages assessed by 3-day food records
Time Frame
Baseline, 3, 6, 9, 12 months
Title
Change in percent overBMI
Description
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
Time Frame
Baseline, 3, 6, 9, 12 months
Other Pre-specified Outcome Measures:
Title
Change in parental BMI (kg/m2)
Description
Assessment of change in BMI of the caregiver primary attending the intervention with the child.
Time Frame
Baseline, 3, 6, 9, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk E. Bock, M.D.
Organizational Affiliation
University of Western Ontario, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital, London Health Sciences Centre, University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs