Lifestyle Intervention for Toddlers Pilot Study

Study Overview
=================
Brief Summary
-----------------
Study aims to pilot a family-centred tailored nutrition intervention at child welfare clinics, targeting the previously observed dietary defaults of Finnish children.

Detailed Description
-----------------
Eating habits can predict diet-related health problems and obesity. The defaults observed previously in the diet of Finnish children include low consumption of vegetables, fruits and vegetable oil-based fats, high consumption of sucrose, poor quality of drinks and low frequency of family meals. Child welfare clinic is the place to promote healthy lifestyles because most Finnish families visit there at regular intervals.

Official Title
-----------------
Lifestyle Intervention for Toddlers at Finnish Welfare Clinics

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Intensified dietary counseling at child wellfare clinics.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all families at their child's standard 6-month child welfare clinic visit Exclusion Criteria: families with twins families who do not speak Finnish

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 6 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensified dietary counseling<br>The dietary intervention consists of tailored dietary counseling, information leaflets and self-evaluation cards given to the families. | Behavioral: Intensified dietary counseling at child wellfare clinics.<br>* The intervention is completed by public health nurses who receive updating education in nutrition. A special training in a family-centred lifestyle counseling method in implemented. The nutrition intervention consists of tailored dietary counseling, information leaflets and self-evaluation card given to the families in the intervention arm. In the control clinics, public health nurses continue their usual dietary counseling.<br>|
| Active Comparator: Normal dietary counseling<br>Public health nurses continue their usual dietary counseling. | Behavioral: Intensified dietary counseling at child wellfare clinics.<br>* The intervention is completed by public health nurses who receive updating education in nutrition. A special training in a family-centred lifestyle counseling method in implemented. The nutrition intervention consists of tailored dietary counseling, information leaflets and self-evaluation card given to the families in the intervention arm. In the control clinics, public health nurses continue their usual dietary counseling.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To promote child's and family's healthy diet | Changes in family's dietary choices, knowledge and attitudes. Also changes in parent's motivation and self-efficiency to improve family's diet. | 8 months |