Nutrition and healthy lifestyle program
| ISRCTN | ISRCTN38896885 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38896885 |
| Secondary identifying numbers | 0001 |
- Submission date
- 30/05/2016
- Registration date
- 06/06/2016
- Last edited
- 31/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
491 Eglinton Ave W
Toronto
M5N 1A8
Canada
Study information
| Study design | Single-center interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A pilot outpatient community-based pediatric obesity treatment program |
| Study objectives | The study aims to determine whether a multi-disciplinary intervention to treat childhood obesity has a beneficial effect. |
| Ethics approval(s) | Toronto Academic Health Sciences Network (TAHSN), Canada, approval pending, expected 01/07/2016 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2016 |
| Completion date | 01/09/2018 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 12 children and their families |
| Key inclusion criteria | Ages 7-12 with body mass index greater than 85% percentile |
| Key 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 |
| Date of first enrolment | 02/07/2016 |
| Date of final enrolment | 30/09/2016 |
Locations
Countries of recruitment
- Canada
Study participating centre
Toronto
M5N 1A8
Canada
Sponsor information
Hospital/treatment centre
491 Eglinton Avenue #301
Toronto
M5N 1A8
Canada
"ROR" |
https://ror.org/03h1ytk17 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/09/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
| IPD sharing plan |
Editorial Notes
31/10/2017: Internal review.
