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Early Stockholm Obesity Prevention Program (EarlySTOPP)

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ClinicalTrials.gov Identifier: NCT01198847
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Claude Marcus, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE September 9, 2010
First Posted Date  ICMJE September 10, 2010
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE January 2010
Actual Primary Completion Date January 2014   (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
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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.

The Low intensity arm will only receive written information and no direct face to face support

Study Arms  ICMJE
  • Active Comparator: Low intensity arm
    Written information about a healthy lifestyle
    Intervention: Behavioral: Dietary, physical activity and sleeping
  • Experimental: High intensity arm
    Lifestyle support (PA, sleep, food intake) using MI
    Intervention: Behavioral: Dietary, physical activity and sleeping
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2019)
195
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2010)
250
Actual Study Completion Date  ICMJE March 2019
Actual Primary Completion Date January 2014   (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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 1 Year   (Child)
Accepts Healthy Volunteers  ICMJE 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  ICMJE Not Provided
Responsible Party Claude Marcus, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: claude marcus, MD, PhD Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date August 2019

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