Early Stockholm Obesity Prevention Program

Study Overview
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Brief Summary
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To study whether a targeted intervention can prevent the development of overweight and obesity among pre-school children in families with either one obese or two overweight parents.

Detailed Description
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Early STOPP project wants to promote good health in children from early age by supporting good habits for the whole family. Our aim is to see if we can prevent overweight and obesity in children in families where parents are overweight or obese. Normal weight parents will also be needed in this study. Background Life is in constant change and affects our habits. In many ways this is positive but it also contributes to less favorable health factors. For example, take the car instead of cycling, take the lift instead of the stairs. This makes us less active in everyday life. Individuals also eat more unhealthy foods in larger portions. In combination with genetics, social in heritage and surrounding factors this contributes to increase overweight and obesity among children not only in adults but also in children. Good treatment methods for childhood obesity are lacking, making prevention very important. The earlier good habits are introduced to a child the better it is. In Early STOPP project we study food, physical activity and sleep habits in the families with a little child. The height, weight, waist circumference and blood pressure will be recorded in both child and parents. The parents will answer questionnaires about food, physical activity and sleeping habits for both the child and themselves. During the study, the child's physical activity will be measured.

Official Title
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A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Behavioral: Dietary, physical activity and sleeping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: one obese or two overweight parents, 1 year old child Exclusion Criteria: weight effecting diseases

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low intensity arm<br>Written information about a healthy lifestyle | Behavioral: Dietary, physical activity and sleeping<br>* The intervention in the present study will be delivered through sessions aiming at developing healthy lifestyle habits regarding physical activity, food intake and regular sleeping habits for parents and children. These sessions will be performed face to face by trained health care workers and carried out in the welfare centres with the parent/s. Children will not be approached directly in the present study. All families will meet with their coach/facilitator during at least 12 times (including start and final evaluation meeting) until the children reach 6 years of age (such as school age). However extra effort (as boosting sessions) will be made if growth records show an increased BMI (weight induced meetings). The parents are also encouraged to keep contact with their coach either by phone or e-mail as often as they feel needed. The Low intensity arm will only receive written information and no direct face to face support<br>|
| Experimental: High intensity arm<br>Lifestyle support (PA, sleep, food intake) using MI | Behavioral: Dietary, physical activity and sleeping<br>* The intervention in the present study will be delivered through sessions aiming at developing healthy lifestyle habits regarding physical activity, food intake and regular sleeping habits for parents and children. These sessions will be performed face to face by trained health care workers and carried out in the welfare centres with the parent/s. Children will not be approached directly in the present study. All families will meet with their coach/facilitator during at least 12 times (including start and final evaluation meeting) until the children reach 6 years of age (such as school age). However extra effort (as boosting sessions) will be made if growth records show an increased BMI (weight induced meetings). The parents are also encouraged to keep contact with their coach either by phone or e-mail as often as they feel needed. The Low intensity arm will only receive written information and no direct face to face support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention | Weight gain, reflected in BMI sds will reflect if the intervention has been successful | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleeping behavior | sleeping duration will be monitored to study its effect on intervention | 5 years | 
| biomarkers | such as bacterial population in feces, markers in blood and in saliva | 5 years | 
| physical activity and sedentary behaviour | physical activity and sedentary behavious will be monitored during the intervention | 5 years | 
| dietary intake | changes in dietary habits and behaviour will be monitored | 5 years | 
| socioeconomic factors | factors effecting obesity development will be assessed in order to understand their impact on intervention | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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child overweight, child obesity, prevention, targeted intervention, development of overweight