Clinical trial NCT01198847: Early Stockholm Obesity Prevention Program
Official title: A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: child overweight
child obesity
prevention
targeted intervention
development of overweight
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 195
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* weight effecting diseases

Primary outcomes:
measure: Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention
timeFrame: 5 years
Secondary outcomes:
measure: sleeping behavior
timeFrame: 5 years
measure: biomarkers
timeFrame: 5 years
measure: physical activity and sedentary behaviour
timeFrame: 5 years
measure: dietary intake
timeFrame: 5 years
measure: socioeconomic factors
timeFrame: 5 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
state: Stcokholm
Study officials:
affiliation: Karolinska Institutet
name: claude marcus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sobko T, Svensson V, Ek A, Ekstedt M, Karlsson H, Johansson E, Cao Y, Hagstromer 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.
citation: Bergqvist-Noren L, Hagman E, Xiu L, Marcus C, Hagstromer M. Physical activity in early childhood: a five-year longitudinal analysis of patterns and correlates. Int J Behav Nutr Phys Act. 2022 Apr 20;19(1):47. doi: 10.1186/s12966-022-01289-x.
citation: Xiu L, Ekstedt M, Hagstromer M, Bruni O, Bergqvist-Noren L, Marcus C. Sleep and Adiposity in Children From 2 to 6 Years of Age. Pediatrics. 2020 Mar;145(3):e20191420. doi: 10.1542/peds.2019-1420. Epub 2020 Feb 18.
citation: Johansson E, Hagstromer M, Svensson V, Ek A, Forssen M, Nero H, Marcus C. Objectively measured physical activity in two-year-old children - levels, patterns and correlates. Int J Behav Nutr Phys Act. 2015 Jan 24;12:3. doi: 10.1186/s12966-015-0161-0.