NCT02396784

Brief Summary

Early STOPP project promotes 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: Several daily habits lead to less favorable health factors. For example, using the car instead of cycling or walking - leads to less activity 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 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 child of one year of age. 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. Based on our observations we aim to develop the preventive strategies for the families with very young children.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 5, 2018

Status Verified

March 1, 2018

Enrollment Period

7.9 years

First QC Date

March 18, 2015

Last Update Submit

March 2, 2018

Conditions

Keywords

child overweightchild obesitypreventiontargeted interventiondevelopment of overweight

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index score(BMI sds) at the age 6 years

    Weight gain, reflected in BMI sds will reflect the difference between two groups (case group and control group)

    5 years

Secondary Outcomes (5)

  • sleeping hehavior

    5 years

  • biomarkers

    5 years

  • physical activity and sedentary behavious

    5 years

  • dietary intake

    5 years

  • socioeconomic factors

    5 years

Study Arms (2)

High risk

One parent has a BMI of greater than or equal to 28, or both parents have a BMI of greater than or equal to 24

Normal risk

Both parents have a BMI of smaller than 24

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children aged 1-6 yrs

You may qualify if:

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

You may not qualify if:

  • weight effecting diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Medical College

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

OverweightObesityPediatric Obesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tanja Sobko, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 18, 2015

First Posted

March 24, 2015

Study Start

January 1, 2011

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 5, 2018

Record last verified: 2018-03

Locations