Early Stockholm Obesity Prevention Program (EarlySTOPP)

Tracking Information
First Submitted Date ICMJE	September 9, 2010
First Posted Date ICMJE	September 10, 2010
Last Update Posted Date	June 27, 2011
Study Start Date ICMJE	January 2010
Estimated Primary Completion Date	January 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 13, 2010)	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
Original Primary Outcome Measures ICMJE; (submitted: September 9, 2010)	BMI sds score 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
Change History	Complete list of historical versions of study NCT01198847 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 13, 2010)	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
Original Secondary Outcome Measures ICMJE; (submitted: September 9, 2010)	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 fece, 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
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Early Stockholm Obesity Prevention Program
Official Title ICMJE	A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity
Brief Summary	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	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 ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Obesity; Overweight
Intervention ICMJE	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.
Study Arms	Not Provided
Publications *	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.; Johansson E, Hagströmer M, Svensson V, Ek A, Forssén M, Nero H, Marcus C. Objectively measured physical activity in two-year-old children - levels, patterns and correlates. Int J Behav Nutr Phys Act. 2015 Jan 24;12:3. doi: 10.1186/s12966-015-0161-0.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: September 9, 2010)	250
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	March 2016
Estimated Primary Completion Date	January 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: one obese or two overweight parents, 1 year old child Exclusion Criteria: weight effecting diseases
Sex/Gender	Sexes Eligible for Study: All
Ages	1 Year to 1 Year (Child)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Sweden
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01198847
Other Study ID Numbers ICMJE	ES-2010
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	CLINTEC, Karolinska Institutet
Study Sponsor ICMJE	Karolinska Institutet
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Tanja Sobko, PhD Karolinska Institutet Principal Investigator: claude marcus, PhD Karolinska Institutet
PRS Account	Karolinska Institutet
Verification Date	June 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP