Early Stockholm Obesity Prevention Program (EarlySTOPP)

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: Dietary, physical activity and sleeping

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 Type: Interventional
• Enrollment (Actual): 195
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stcokholm
    • Stockholm, Stcokholm, Sweden, 141 86
      • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• weight effecting diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low intensity arm; Written information about a healthy lifestyle	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
Experimental: High intensity arm; Lifestyle support (PA, sleep, food intake) using MI	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleeping behavior	sleeping duration will be monitored to study its effect on intervention	5 years
biomarkers	such as bacterial population in feces, markers in blood and in saliva	5 years
physical activity and sedentary behaviour	physical activity and sedentary behavious will be monitored during the intervention	5 years
dietary intake	changes in dietary habits and behaviour will be monitored	5 years
socioeconomic factors	factors effecting obesity development will be assessed in order to understand their impact on intervention	5 years

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: claude marcus, MD, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: September 9, 2010
• First Submitted That Met QC Criteria: September 9, 2010
• First Posted (Estimate): September 10, 2010

Study Record Updates

• Last Update Posted (Actual): August 14, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: prevention; child obesity; child overweight; targeted intervention; development of overweight
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: ES-2010