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Early Stockholm Obesity Prevention Program (EarlySTOPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Behavioral: Dietary, physical activity and sleeping Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity
Actual Study Start Date : January 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : March 2019

Arm Intervention/treatment
Active Comparator: Low intensity arm
Written information about a healthy lifestyle
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


Experimental: High intensity arm
Lifestyle support (PA, sleep, food intake) using MI
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





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. sleeping behavior [ Time Frame: 5 years ]
    sleeping duration will be monitored to study its effect on intervention

  2. biomarkers [ Time Frame: 5 years ]
    such as bacterial population in feces, markers in blood and in saliva

  3. physical activity and sedentary behaviour [ Time Frame: 5 years ]
    physical activity and sedentary behavious will be monitored during the intervention

  4. dietary intake [ Time Frame: 5 years ]
    changes in dietary habits and behaviour will be monitored

  5. socioeconomic factors [ Time Frame: 5 years ]
    factors effecting obesity development will be assessed in order to understand their impact on intervention



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Ages Eligible for Study:   1 Year to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • weight effecting diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198847


Locations
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Sweden
Karolinska Institutet
Stockholm, Stcokholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: claude marcus, MD, PhD Karolinska Institutet
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Claude Marcus, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01198847    
Other Study ID Numbers: ES-2010
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by Claude Marcus, Karolinska Institutet:
child overweight
child obesity
prevention
targeted intervention
development of overweight
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms