FOR HEALTH: A Family-oriented Healthy Eating, Activity and Lifestyle Intervention for Obese Preschool Children and Their Families.
This study is currently recruiting participants.
Verified April 2013 by Lawson Health Research Institute
Sponsor:
Lawson Health Research Institute
Information provided by (Responsible Party):
Dirk Bock, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01698606
First received: October 1, 2012
Last updated: April 17, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The aim of this study is to investigate whether a community-based 6-month intervention for obese preschool children 2-5 years of age and their families, referred by their family physician, will be successful in preventing further increase in the participants' degree of obesity.
Participating children will be randomized to either receive a multidisciplinary lifestyle intervention during the first 6 months, treatment arm, or 6 months later, control or wait list arm. Within each arm participants will further be randomized to either a standard intervention group, or to an extended intervention group, which will receive an additional free 6-month YMCA membership.
| 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 - 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: | 32 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (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 obesity, BMI > 97th 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: Meghan Rombeek, MSc, RD | 519-685-8500 |
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: | April 17, 2013 |
| 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 Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013