Early Stockholm Obesity Prevention Program (EarlySTOPP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2011 by Karolinska Institutet
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01198847
First received: September 9, 2010
Last updated: June 22, 2011
Last verified: June 2011

September 9, 2010
June 22, 2011
January 2010
January 2012   (final data collection date for primary outcome measure)
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
BMI sds score 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
Complete list of historical versions of study NCT01198847 on ClinicalTrials.gov Archive Site
  • 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
  • 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 fece, 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
Not Provided
Not Provided
 
Early Stockholm Obesity Prevention Program
A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Obesity
  • Overweight
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.
Not Provided
Sobko T, Svensson V, Ek A, Ekstedt M, Karlsson H, Johansson E, Cao Y, Hagströmer M, Marcus C. A randomised controlled trial for overweight and obese parents to prevent childhood obesity--Early STOPP (STockholm Obesity Prevention Program). BMC Public Health. 2011 May 18;11:336. doi: 10.1186/1471-2458-11-336.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
March 2016
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • one obese or two overweight parents, 1 year old child

Exclusion Criteria:

  • weight effecting diseases
Both
1 Year to 1 Year
Yes
Contact: Tanja Sobko, PhD +46704045996 tanja.sobko@ki.se
Sweden
 
NCT01198847
ES-2010
Yes
CLINTEC, Karolinska Institutet
Karolinska Institutet
Not Provided
Study Chair: Tanja Sobko, PhD Karolinska Institutet
Principal Investigator: claude marcus, PhD Karolinska Institutet
Karolinska Institutet
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP