Brief Summary

This intervention aims to reduce obesity by using new type of nutritional and lifestyle therapy and in parallel, tailored persuasive information and communications technology (ICT)-technology based application. The study hypothesis is that obesity cannot be reduced just by distributing nutritional information. Instead, by influencing also the eating behavior, permanent lifestyle changes can be achieved. The effect of the therapy along the time-line, the health information literacy of the study persons and the changes in it will be studied at different phases of the intervention. The research will be carried out in three main groups of different levels of nutritional therapies with a parallel ICT-intervention and control group for each main group (altogether six groups).

Trial Health

Monitor

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

574

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

active not recruiting

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

12.8 years study duration

Study Start

First participant enrolled

February 1, 2013

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2013

Completed

1 month until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed

6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed

6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed

Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

6.8 years

First QC Date

September 6, 2013

Last Update Submit

October 28, 2024

Conditions

Metabolic Syndrome Obesity Overweight Cardiovascular Disease

Keywords

Metabolic syndromeobesityoverweightweight loss interventioncognitive behavioral therapyICT interventioncardiovascular diseasepersuasive systems design

Outcome Measures

Primary Outcomes (1)

Weight change
Baseline, 1 , 2 and 5 years

Secondary Outcomes (1)

Change in eating behavior
Baseline, 1, 2 and 5 years

Other Outcomes (1)

Change in metabolic syndrome related blood measures
Baseline, 1, 2 and 5 years

Study Arms (6)

Weight loss counseling with ICT intervention

EXPERIMENTAL

Cognitive behavioral therapy-based weight loss counseling program including 8 group visits. Participant have also persuasive ICT support.