NCT01204489

Brief Summary

Study aims to pilot a family-centred tailored nutrition intervention at child welfare clinics, targeting the previously observed dietary defaults of Finnish children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 21, 2012

Status Verified

June 1, 2011

Enrollment Period

1.7 years

First QC Date

September 16, 2010

Last Update Submit

June 20, 2012

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • To promote child's and family's healthy diet

    Changes in family's dietary choices, knowledge and attitudes. Also changes in parent's motivation and self-efficiency to improve family's diet.

    8 months

Study Arms (2)

Intensified dietary counseling

EXPERIMENTAL

The dietary intervention consists of tailored dietary counseling, information leaflets and self-evaluation cards given to the families.

Behavioral: Intensified dietary counseling at child wellfare clinics.

Normal dietary counseling

ACTIVE COMPARATOR

Public health nurses continue their usual dietary counseling.

Behavioral: Intensified dietary counseling at child wellfare clinics.

Interventions

Intensified dietary counseling at child wellfare clinics.BEHAVIORAL

The intervention is completed by public health nurses who receive updating education in nutrition. A special training in a family-centred lifestyle counseling method in implemented. The nutrition intervention consists of tailored dietary counseling, information leaflets and self-evaluation card given to the families in the intervention arm. In the control clinics, public health nurses continue their usual dietary counseling.

Intensified dietary counselingNormal dietary counseling

Eligibility Criteria

Age6 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • all families at their child's standard 6-month child welfare clinic visit

You may not qualify if:

  • families with twins
  • families who do not speak Finnish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child welfare clinics

Espoo, Uusimaa, 02070, Finland

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Suvi M Virtanen, Professor

    Head of the Nutrition Unit, professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2010

First Posted

September 17, 2010

Study Start

September 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 21, 2012

Record last verified: 2011-06

Locations

FI(1)