NCT01813903

Brief Summary

The purpose of this study was to test internet and mobile-based applications to support motivating lifestyle counseling to promote healthy eating habits of the mothers and their spouses expecting first child. The feasibility of the intervention will be evaluated in the pilot.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Apr 2013

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

First Submitted

Initial submission to the registry

March 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

1.9 years

First QC Date

March 12, 2013

Last Update Submit

June 5, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Food consumption of the parents

    Measured with Food Frequency Questionnaire

    7 months

  • Maternal post-natal depression

    Measured with Edinburgh Postnatal Depression Scale (EDPS)

    9 months

Secondary Outcomes (3)

  • Food and health related attitudes and aims of the parent's

    9 months

  • Psychological flexibility of the parent's

    9 months

  • Mental health of the parent's

    9 months

Study Arms (3)

Nutrition

EXPERIMENTAL

Intensified dietary counseling and use of web application.

Behavioral: Intensified dietary counseling

Flexible mind

EXPERIMENTAL

Use of mobile applications.

Behavioral: Mobile application

Normal maternity clinic visits

NO INTERVENTION

In control maternity clinics, nurses continue their usual counseling.

Interventions

The intervention is completed by public health nurses who will be trained to provide family-centered empowering and motivational lifestyle counseling at the normal health check visit. Parents expecting child will use web application developed for nutritional counseling. Web application consists of dietary questionnaire from which the parents will receive immediately automatic feedback. Feedback concerns the quality of diet in relation to the Finnish nutrition recommendations. Feedback will be given in an encouraging format. Own targets of food changes can also be recorded in the application, and the application can be used to monitor how they are achieved.

Nutrition

Mothers expecting child will use mobile application. Mobile application consists of text, audio and video exercises, which are aimed to increase the psychological flexibility and thus mental and physical well-being.

Flexible mind

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All families expecting their child at their standard 8-10 pregnancy weeks welfare clinic visit

You may not qualify if:

  • Parents are under 18-year-old
  • Parents do not speak Finnish
  • Parents do not have internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternal welfare clinics

Vantaa, 01300, Finland

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Suvi I Virtanen, Professor

    Finnish Institute for Health and Welfare

    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

March 12, 2013

First Posted

March 19, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2015

Study Completion

May 1, 2015

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations