Early Stockholm Obesity Prevention Program (EarlySTOPP)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity Overweight |
Behavioral: Dietary, physical activity and sleeping |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity |
- Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention [ Time Frame: 5 years ] [ Designated as safety issue: No ]Weight gain, reflected in BMI sds will reflect if the intervention has been successful
- sleeping behavior [ Time Frame: 5 years ] [ Designated as safety issue: No ]sleeping duration will be monitored to study its effect on intervention
- biomarkers [ Time Frame: 5 years ] [ Designated as safety issue: No ]such as bacterial population in feces, markers in blood and in saliva
- physical activity and sedentary behaviour [ Time Frame: 5 years ] [ Designated as safety issue: No ]physical activity and sedentary behavious will be monitored during the intervention
- dietary intake [ Time Frame: 5 years ] [ Designated as safety issue: No ]changes in dietary habits and behaviour will be monitored
- socioeconomic factors [ Time Frame: 5 years ] [ Designated as safety issue: No ]factors effecting obesity development will be assessed in order to understand their impact on intervention
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
-
Behavioral: Dietary, physical activity and sleeping
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.
Eligibility| Ages Eligible for Study: | 1 Year to 1 Year |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- one obese or two overweight parents, 1 year old child
Exclusion Criteria:
- weight effecting diseases
Contacts and Locations| Contact: Tanja Sobko, PhD | +46704045996 | tanja.sobko@ki.se |
| Sweden | |
| Karolinska Institutet | Recruiting |
| Stockholm, Stcokholm, Sweden, 141 86 | |
| Principal Investigator: Claude Marcus, PhD | |
| Study Chair: | Tanja Sobko, PhD | Karolinska Institutet |
| Principal Investigator: | claude marcus, PhD | Karolinska Institutet |
More Information
Publications:
| Responsible Party: | CLINTEC, Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT01198847 History of Changes |
| Other Study ID Numbers: | ES-2010 |
| Study First Received: | September 9, 2010 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Karolinska Institutet:
|
child overweight child obesity prevention targeted intervention development of overweight |
Additional relevant MeSH terms:
|
Obesity Overweight Overnutrition |
Nutrition Disorders Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013