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Early Stockholm Obesity Prevention Program (EarlySTOPP)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Karolinska Institutet.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Karolinska Institutet
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01198847
First received: September 9, 2010
Last updated: June 22, 2011
Last verified: June 2011
| Tracking Information | |||||||
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| First Received Date ICMJE | September 9, 2010 | ||||||
| Last Updated Date | June 22, 2011 | ||||||
| Start Date ICMJE | January 2010 | ||||||
| Estimated Primary Completion Date | January 2012 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE |
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 |
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| Change History | Complete list of historical versions of study NCT01198847 on ClinicalTrials.gov Archive Site | ||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||
| Study Phase | Not Provided | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| 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. |
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| Study Arms | Not Provided | ||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Unknown status | ||||||
| Estimated Enrollment ICMJE | 250 | ||||||
| Estimated Completion Date | March 2016 | ||||||
| Estimated Primary Completion Date | January 2012 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| 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 | ||||||
| Plan to Share Data | Not Provided | ||||||
| IPD Description | Not Provided | ||||||
| Responsible Party | CLINTEC, Karolinska Institutet | ||||||
| Study Sponsor ICMJE | Karolinska Institutet | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Karolinska Institutet | ||||||
| Verification Date | June 2011 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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