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
  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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   1 Year to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • weight effecting diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01198847

Contacts
Contact: Tanja Sobko, PhD +46704045996 tanja.sobko@ki.se

Locations
Sweden
Karolinska Institutet Recruiting
Stockholm, Stcokholm, Sweden, 141 86
Principal Investigator: Claude Marcus, PhD         
Sponsors and Collaborators
Karolinska Institutet
Investigators
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 July 20, 2014