Family Welfare Pilot Intervention Study

Obesity Clinical Trial

— HYPE  

Official title:

Family Welfare Pilot Intervention Study at Finnish Welfare Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01813903
• Other study ID #: THL10433
• Status: Completed
• Phase: N/A
• First received: March 12, 2013
• Last updated: June 5, 2015
• Start date: April 2013
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: National Institute for Health and Welfare, Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Lifestyle habits during pregnancy have long-term effects of baby's as well as mother's health. Pregnancy period is a favorable time for lifestyle changes, as the parents usually have motivation and assets to change lifestyle. Maternity welfare clinic is the place to promote healthy lifestyles because most Finnish families expecting child visit there at regular intervals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Parents are under 18-year-old

• Parents do not speak Finnish

• Parents do not have internet access

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Intensified dietary counseling
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.
• Mobile application
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.

Locations

Country	Name	City	State
Finland	Maternal welfare clinics	Vantaa

Sponsors (7)

Lead Sponsor	Collaborator
National Institute for Health and Welfare, Finland	Helsinki University, The Finnish Heart Association, The National Consumer Research Centre, University of Jyvaskyla, University of Tampere, VTT Technical Research Centre of Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food consumption of the parents	Measured with Food Frequency Questionnaire	7 months	No
Primary	Maternal post-natal depression	Measured with Edinburgh Postnatal Depression Scale (EDPS)	9 months	No
Secondary	Food and health related attitudes and aims of the parent's	Questions about food and health related attitudes and aims	9 months	No
Secondary	Psychological flexibility of the parent's	Measured with Acceptance & Action Questionnaire (AAQ-2)	9 months	No
Secondary	Mental health of the parent's	Measured with Mental Health Continuum Short Form (MHC-SF)	9 months	No