Vaasa Childhood Obesity Primary Prevention Study

NCT00970710 | Completed DMC

• 1 other identifier: 100454
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to prevent childhood obesity with early life (pregnancy) intensified counselling. The recruited intervention group is pregnant mothers who are at risk to get gestational diabetes. Lifestyle intervention (nutritional and physical activity) begins during pregnancy in maternity clinics and continues in child wellfare clinics until the child is 5 years of age.

Conditions

Childhood Obesity Pevention

Outcome Measures

Primary Outcomes (1)

• Preventing childhood obesity

  Difference in offspring weight gain compared to control group

  Offspring age until six years

Secondary Outcomes (2)

• lower cholesterol values

  up to six years

• lower HOMA-index

  up to six years

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL

VACOPP (Vaasa Childhood Obesity Primary Prevention Study): Intensified lifestyle counseling including physical activity and nutritional information beginning during maternity health care and continuing during child health care clinic visits.

Behavioral: Vaasa Childhood Obesity Primary Prevention Study

Interventions

Vaasa Childhood Obesity Primary Prevention Study BEHAVIORAL

Intensified counselling concerning healthy diet and suitable physical activity during pregnancy to mothers in the intervention group continuing in child health care clinic visits with the offspring until child's age of 5 year.

Also known as: VACOPP

Lifestyle counseling

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pregnant women who are at risk to get gestational diabetes.

You may not qualify if:

• Foreigner with language problems
• Major psychosocial problems
• Diabetes mellitus type I or II
• Physical disability,
• Major medical problems in pregnancy

Sponsors & Collaborators

• Tampere University: lead
• Foundation for Paediatric Research, Finland: collaborator
• Vaasa Health care center: collaborator
• Seinajoki Central Hospital: collaborator
• Tampere University Hospital: collaborator

Study Sites (1)

Health care center in Vaasa

Vaasa, 65320, Finland

Location

Related Publications (3)

• Mustila T, Raitanen J, Keskinen P, Luoto R. A pragmatic controlled trial to prevent childhood obesity within a risk group at maternity and child health-care clinics: results up to six years of age (the VACOPP study). BMC Pediatr. 2018 Feb 27;18(1):89. doi: 10.1186/s12887-018-1065-3.

  PMID: 29486763 DERIVED

• Mustila T, Raitanen J, Keskinen P, Saari A, Luoto R. Pragmatic controlled trial to prevent childhood obesity in maternity and child health care clinics: pregnancy and infant weight outcomes (the VACOPP Study). BMC Pediatr. 2013 May 20;13:80. doi: 10.1186/1471-2431-13-80.

  PMID: 23688259 DERIVED

• Mustila T, Keskinen P, Luoto R. Behavioral counseling to prevent childhood obesity--study protocol of a pragmatic trial in maternity and child health care. BMC Pediatr. 2012 Jul 3;12:93. doi: 10.1186/1471-2431-12-93.

  PMID: 22759439 DERIVED

Study Officials

• Taina E. Mustila, M.D. Ph.D.

  Seinajoki Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Ph.D.

Model Details: Pragmatic controlled trial

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: January 1, 2009
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: February 14, 2017

Record last verified: 2017-02

Locations

FI (1)