Early Stockholm Obesity Prevention Program

Obesity Clinical Trial

— EarlySTOPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198847
• Other study ID #: ES-2010
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: March 2019

Study information

• Verified date: August 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: March 2019
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 1 Year

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• weight effecting diseases

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm	Stcokholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Sobko T, Svensson V, Ek A, Ekstedt M, Karlsson H, Johansson E, Cao Y, Hagströmer M, Marcus C. A randomised controlled trial for overweight and obese parents to prevent childhood obesity--Early STOPP (STockholm Obesity Prevention Program). BMC Public Health. 2011 May 18;11:336. doi: 10.1186/1471-2458-11-336. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention	Weight gain, reflected in BMI sds will reflect if the intervention has been successful	5 years
Secondary	sleeping behavior	sleeping duration will be monitored to study its effect on intervention	5 years
Secondary	biomarkers	such as bacterial population in feces, markers in blood and in saliva	5 years
Secondary	physical activity and sedentary behaviour	physical activity and sedentary behavious will be monitored during the intervention	5 years
Secondary	dietary intake	changes in dietary habits and behaviour will be monitored	5 years
Secondary	socioeconomic factors	factors effecting obesity development will be assessed in order to understand their impact on intervention	5 years