Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/05/2016
Date assigned
06/06/2016
Last edited
06/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Type

Scientific

Primary contact

Dr Daniel Flanders

ORCID ID

Contact details

491 Eglinton Ave W
Toronto
M5N 1A8
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0001

Study information

Scientific title

A pilot outpatient community-based pediatric obesity treatment program

Acronym

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

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

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

Condition

Childhood obesity

Intervention

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

Behavioural

Phase

Drug names

Primary outcome measures

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

None

Overall trial start date

01/09/2016

Overall trial end date

01/09/2018

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Other

Age group

Child

Gender

Both

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

02/07/2016

Recruitment end date

30/09/2016

Locations

Countries of recruitment

Canada

Trial participating centre

Kindercare Pediatrics
491 Eglinton Avenue West
Toronto
M5N 1A8
Canada

Sponsor information

Organisation

Kindercare Pediatrics (Canada)

Sponsor details

491 Eglinton Avenue #301
Toronto
M5N 1A8
Canada

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Kindercare Pediatrics (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes