NCT01198847

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

4 years

First QC Date

September 9, 2010

Last Update Submit

August 12, 2019

Conditions

ObesityOverweight

Keywords

child overweightchild obesitypreventiontargeted interventiondevelopment of overweight

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • sleeping behavior

    5 years

  • biomarkers

    5 years

  • physical activity and sedentary behaviour

    5 years

  • dietary intake

    5 years

  • socioeconomic factors

    5 years

Study Arms (2)

Low intensity arm

ACTIVE COMPARATOR

Written information about a healthy lifestyle

Behavioral: Dietary, physical activity and sleeping

High intensity arm

EXPERIMENTAL

Lifestyle support (PA, sleep, food intake) using MI

Behavioral: Dietary, physical activity and sleeping

Interventions

Dietary, physical activity and sleepingBEHAVIORAL

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

High intensity armLow intensity arm

Eligibility Criteria

Age1 Year - 1 Year
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • weight effecting diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Stcokholm, 141 86, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 21592388BACKGROUND

  • 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.

    PMID: 35443696DERIVED

  • 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.

    PMID: 32071262DERIVED

  • 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.

    PMID: 25616495DERIVED

MeSH Terms

Conditions

ObesityOverweightPediatric Obesity

Interventions

DietExerciseSleep

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNervous System Physiological Phenomena

Study Officials

  • claude marcus, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 10, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2014

Study Completion

March 1, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations

SE(1)