Early Stockholm Obesity Prevention Program (EarlySTOPP)
Primary Purpose
Obesity, Overweight
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Dietary, physical activity and sleeping
Sponsored by

About this trial
This is an interventional prevention trial for Obesity focused on measuring child overweight, child obesity, prevention, targeted intervention, development of overweight
Eligibility Criteria
Inclusion Criteria:
- one obese or two overweight parents, 1 year old child
Exclusion Criteria:
- weight effecting diseases
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Low intensity arm
High intensity arm
Arm Description
Written information about a healthy lifestyle
Lifestyle support (PA, sleep, food intake) using MI
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
sleeping behavior
sleeping duration will be monitored to study its effect on intervention
biomarkers
such as bacterial population in feces, markers in blood and in saliva
physical activity and sedentary behaviour
physical activity and sedentary behavious will be monitored during the intervention
dietary intake
changes in dietary habits and behaviour will be monitored
socioeconomic factors
factors effecting obesity development will be assessed in order to understand their impact on intervention
Full Information
NCT ID
NCT01198847
First Posted
September 9, 2010
Last Updated
August 12, 2019
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT01198847
Brief Title
Early Stockholm Obesity Prevention Program
Acronym
EarlySTOPP
Official Title
A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
child overweight, child obesity, prevention, targeted intervention, development of overweight
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
195 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low intensity arm
Arm Type
Active Comparator
Arm Description
Written information about a healthy lifestyle
Arm Title
High intensity arm
Arm Type
Experimental
Arm Description
Lifestyle support (PA, sleep, food intake) using MI
Intervention Type
Behavioral
Intervention Name(s)
Dietary, physical activity and sleeping
Intervention Description
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 Measure Information:
Title
Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention
Description
Weight gain, reflected in BMI sds will reflect if the intervention has been successful
Time Frame
5 years
Secondary Outcome Measure Information:
Title
sleeping behavior
Description
sleeping duration will be monitored to study its effect on intervention
Time Frame
5 years
Title
biomarkers
Description
such as bacterial population in feces, markers in blood and in saliva
Time Frame
5 years
Title
physical activity and sedentary behaviour
Description
physical activity and sedentary behavious will be monitored during the intervention
Time Frame
5 years
Title
dietary intake
Description
changes in dietary habits and behaviour will be monitored
Time Frame
5 years
Title
socioeconomic factors
Description
factors effecting obesity development will be assessed in order to understand their impact on intervention
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
one obese or two overweight parents, 1 year old child
Exclusion Criteria:
weight effecting diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
claude marcus, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
State/Province
Stcokholm
ZIP/Postal Code
141 86
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
21592388
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.
Results Reference
background
PubMed Identifier
35443696
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.
Results Reference
derived
PubMed Identifier
32071262
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.
Results Reference
derived
PubMed Identifier
25616495
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.
Results Reference
derived
Learn more about this trial
Early Stockholm Obesity Prevention Program
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