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Clinical Trials/NCT01198847
NCT01198847CompletedNot Applicable

A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity

Karolinska Institutet2 sites in 1 country195 target enrollmentStarted: January 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
195
Locations
2
Primary Endpoint
Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
1 Year to 1 Year (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • weight effecting diseases

Arms & Interventions

Low intensity arm

Active Comparator

Written information about a healthy lifestyle

Intervention: Dietary, physical activity and sleeping (Behavioral)

High intensity arm

Experimental

Lifestyle support (PA, sleep, food intake) using MI

Intervention: Dietary, physical activity and sleeping (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • sleeping behavior(5 years)
  • socioeconomic factors(5 years)
  • biomarkers(5 years)
  • dietary intake(5 years)
  • physical activity and sedentary behaviour(5 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Claude Marcus

Professor

Karolinska Institutet

Study Sites (2)

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