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CompletedNCT00970710VACOPPUpdated Feb 14, 2017

Vaasa Childhood Obesity Primary Prevention Study

An interventional study of Vaasa Childhood Obesity Primary Prevention Study in Childhood Obesity Pevention, sponsored by Tampere University. Completed at 1 site in Finland. Open to participants aged Up to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-14.

Sponsored by Tampere University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2009, registered Sep 2009).
Phase
Not applicable
Study type
Interventional
Enrollment
185
Allocation
Not applicable
Ages
Up to 6 Years
Sex
All
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Study 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.

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Conditions studied

  • Childhood Obesity Pevention
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In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's enrollment of 185 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Tampere University is the lead sponsor of 61 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
185 participants (actual)

Study arms

  • Experimental
    Lifestyle counseling

    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

  • BehavioralVaasa Childhood Obesity Primary Prevention Study

    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

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What researchers measure

Primary outcomes

  1. Preventing childhood obesity

    Difference in offspring weight gain compared to control group

    Time frame: Offspring age until six years

Secondary outcomes

  1. lower cholesterol values

    Time frame: up to six years

  2. lower HOMA-index

    Time frame: up to six years

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Study locations

1 site
  • Health care center in Vaasa
    Vaasa, 65320, Finland
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References and documents

Publications

  • 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. PubMed 29486763 ↗
  • 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. PubMed 23688259 ↗
  • 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. PubMed 22759439 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00970710
Lead sponsor
Tampere University
Collaborators
Foundation for Paediatric Research, Finland, Vaasa Health care center, Seinajoki Central Hospital, Tampere University Hospital
Responsible party
Taina Mustila (M.D. Ph.D., Seinajoki Central Hospital) — Principal investigator
First posted
Sep 2, 2009
Start date
Jan 1, 2009
Primary completion
Jan 31, 2017
Completion
Jan 31, 2017
Last update
Feb 14, 2017

Study contacts

Taina E. Mustila, M.D. Ph.D.
principal investigator · Seinajoki Central Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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