Early Stockholm Obesity Prevention Program (EarlySTOPP)

• ClinicalTrials.gov Identifier: NCT01198847
• Recruitment Status: Completed
• First Posted: September 10, 2010
• Last Update Posted: August 14, 2019
• Sponsor: Karolinska Institutet
• Information provided by (Responsible Party): Claude Marcus, Karolinska Institutet

Tracking Information

• First Submitted Date: September 9, 2010
• First Posted Date: September 10, 2010
• Last Update Posted Date: August 14, 2019
• Actual Study Start Date: January 2010
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2010)

Body Mass Index score(BMI sds) at the age 6 years to monitor the effectiveness of the intervention [ Time Frame: 5 years ]

Weight gain, reflected in BMI sds will reflect if the intervention has been successful

Original Primary Outcome Measures (submitted: September 9, 2010)

BMI sds score at the age 6 years to monitor the effectiveness of the intervention [ Time Frame: 5 years ]

Weight gain, reflected in BMI sds will reflect if the intervention has been successful

Current Secondary Outcome Measures (submitted: September 13, 2010)

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

Original Secondary Outcome Measures (submitted: September 9, 2010)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Early Stockholm Obesity Prevention Program
• Official Title: A Randomised Controlled Trial for Overweight and Obese Parents to Prevent Childhood Obesity
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• 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

Study Arms

• Active Comparator: Low intensity arm
  Written information about a healthy lifestyle
  Intervention: Behavioral: Dietary, physical activity and sleeping
• Experimental: High intensity arm
  Lifestyle support (PA, sleep, food intake) using MI
  Intervention: Behavioral: Dietary, physical activity and sleeping

Publications *

• 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.
• Xiu L, Ekstedt M, Hagströmer M, Bruni O, Bergqvist-Norén L, Marcus C. Sleep and Adiposity in Children From 2 to 6 Years of Age. Pediatrics. 2020 Mar;145(3). pii: e20191420. doi: 10.1542/peds.2019-1420. Epub 2020 Feb 18.
• Johansson E, Hagströmer M, Svensson V, Ek A, Forssén 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 12, 2019): 195
• Original Estimated Enrollment (submitted: September 9, 2010): 250
• Actual Study Completion Date: March 2019
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• weight effecting diseases

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 1 Year (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT01198847
• Other Study ID Numbers: ES-2010
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Claude Marcus, Karolinska Institutet
• Study Sponsor: Karolinska Institutet
• Collaborators: Not Provided

Investigators

• Principal Investigator: claude marcus, MD, PhD; Karolinska Institutet

• PRS Account: Karolinska Institutet
• Verification Date: August 2019