Early Stockholm Obesity Prevention Program (EarlySTOPP)
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|ClinicalTrials.gov Identifier: NCT01198847|
Recruitment Status : Unknown
Verified June 2011 by Karolinska Institutet.
Recruitment status was: Recruiting
First Posted : September 10, 2010
Last Update Posted : June 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Obesity Overweight||Behavioral: Dietary, physical activity and sleeping||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||March 2016|
- Behavioral: Dietary, physical activity and sleeping
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.
- Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention [ Time Frame: 5 years ]Weight gain, reflected in BMI sds will reflect if the intervention has been successful
- sleeping behavior [ Time Frame: 5 years ]sleeping duration will be monitored to study its effect on intervention
- biomarkers [ Time Frame: 5 years ]such as bacterial population in feces, markers in blood and in saliva
- physical activity and sedentary behaviour [ Time Frame: 5 years ]physical activity and sedentary behavious will be monitored during the intervention
- dietary intake [ Time Frame: 5 years ]changes in dietary habits and behaviour will be monitored
- socioeconomic factors [ Time Frame: 5 years ]factors effecting obesity development will be assessed in order to understand their impact on intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198847
|Contact: Tanja Sobko, PhDemail@example.com|
|Stockholm, Stcokholm, Sweden, 141 86|
|Principal Investigator: Claude Marcus, PhD|
|Study Chair:||Tanja Sobko, PhD||Karolinska Institutet|
|Principal Investigator:||claude marcus, PhD||Karolinska Institutet|