Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
The aim of this study is to assess the effectiveness of a nutrition and healthy lifestyle program that aims to educate children and their families about the importance of healthy eating, healthy living, and exercise.

Who can participate?
Children aged 7-12 with body mass index greater than 85% percentile (defined as overweight) and their families

What does the study involve?
Participants attend monthly group sessions and monthly individual sessions for the first six months. After the first 6 months, participants attend booster sessions at 6-month intervals and ongoing individual sessions as needed. Assessments are carried out before, during, and at the end of the two-year study, and involve completing questionnaires, providing blood samples, and height/weight/waist/blood pressure measurements.

What are the possible benefits and risks of participating?
In addition to direct physical benefits (i.e. healthier lifestyle habits), participants will benefit from learning about their own emotional needs, and having support for mental health difficulties. Participation in the current study may also prompt participants to become more knowledgeable about important issues related to physical wellbeing, such as exercise, eating healthily, and the importance of addressing mental health problems and family functioning in the recovery from pediatric obesity. There are few, if any, safe, cost-effective community-based intervention programs for childhood obesity. This study will enable the development of such an intervention. Emotional risks in participating in the intervention may include feeling uncomfortable, anxious or upset. However, a licenced clinical practitioner will be present at all times during the intervention. Patients will be informed that a licensed mental health practitioner will also be available at any time after the intervention. Participants will be reminded and ensured that they may refrain from completing clinical tests or a question or questionnaire without consequence, should they feel any discomfort about these.

Where is the study run from?
Kindercare Pediatrics (Canada)

When is the study starting and how long is it expected to run for?
July 2016 to September 2016

Who is funding the study?
Kindercare Pediatrics (Canada)

Who is the main contact?
Dr Daniel Flanders

Trial website

Contact information



Primary contact

Dr Daniel Flanders


Contact details

491 Eglinton Ave W
M5N 1A8

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A pilot outpatient community-based pediatric obesity treatment program


Study hypothesis

The study aims to determine whether a multi-disciplinary intervention to treat childhood obesity has a beneficial effect.

Ethics approval

Toronto Academic Health Sciences Network (TAHSN), Canada, approval pending, expected 01/07/2016

Study design

Single-center interventional study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet


Childhood obesity


Participants will be attending monthly group sessions and monthly individual sessions for the first six months. After the first 6 months, participants will attend booster sessions on a 6-month interval and ongoing individual sessions as clinically indicated.

Physical Interventions for Parents and Kids:
1. Mindful eating: understanding hunger and fullness (month 1)
2. Education on frequency of eating different foods (month 1)
3. Education on food groups (proteins, fats, carbohydrates, fiber) (month 1, 2)
4. Education on meal planning and label reading for kids (month 2)
5. Physical activity (month 3)
6. Grocery store tour for kids and adults (month 4)

Mental Health Interventions for Kids:
1. Motivational Interviewing (month 1)
2. Psychoeducation in Peer Support (month 1)
3. Psychoeducation in Coping with emotion and emotional self-efficacy (month 1)
4. Psychoeducation in Tolerating Distress (month 1)
5. Continuation of these interventions through months 3 - 6

Mental Health Interventions for parents:
1. Psychoeducation in empowerment and parental self-efficacy (month 1)
2. Education on identifying mental health issues (month 1)
3. Psychoeducation on coaching children's emotions (month 2)
4. Continuation of these interventions through months 3-6

Booster sessions: at 12 months, 18 months and 24 months
1. Meetings between families and clinicians to check in with progress, identify problems, and recommend intervention applications going forward

Intervention type



Drug names

Primary outcome measure

1. Mental Health measures: All mental health measures will be administered once every month for the first six months of the study, then at 12 months, 18 months, and 24 months (study's completion). These measures include:
1.1. Dutch Eating Behaviour Questionnaire
1.2. Peds QL Quality of Life Questionnaire (administered to the parent and child)
1.3. Parenting Stress Index (Short)

2. Physiological measures:
2.1. Blood work (every 6 months; testing for cholesterol, glucose, inflammation, insulin, iron)
2.2. Height/weight/waist circumference (monthly)
2.3. Blood pressure (monthly)

Secondary outcome measures

No secondary outcomes

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Ages 7-12 with body mass index greater than 85% percentile

Participant type


Age group




Target number of participants

12 children and their families

Participant exclusion criteria

1. Children under the age of 7 years
2. Youth over the age of 12 years
3. Have body mass index under the 85th percentile

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Kindercare Pediatrics
491 Eglinton Avenue West
M5N 1A8

Sponsor information


Kindercare Pediatrics (Canada)

Sponsor details

491 Eglinton Avenue #301
M5N 1A8

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Kindercare Pediatrics (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

We are planning on disseminating results to the Canadian Pediatric Society, the Canadian Obesity Network and their annual Conference, and the Ontario Pediatric and Bariatric Network. Other details are to be confirmed at a later date.

Intention to publish date


Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

31/10/2017: Internal review.