IT-based Training in Obesity

Study Overview
=================
Brief Summary
-----------------
Though possibly cost-saving, there is little scientific evidence for the effectiveness and reasonable modality of internet-delivered physical activity interventions in primary prevention. The aim of the study is to compare the influence of different personal and IT-based service levels on the activity outcome of obese, sedentary persons to evaluate the minimum level of service necessary for a maximum increase in activity and weight reduction.

Official Title
-----------------
Influence of a Combined Personal and IT-based Physical Activity Intervention in an Obese, Sedentary Population on Daily Activity and Metabolic Risk Profile

Conditions
-----------------
Obesity, Inactivity

Intervention / Treatment
-----------------
* Behavioral: Physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physical activity of less than once per week Body-Mass-Index 28-35 kg/m2 Age 35-65 Men and women Exclusion Criteria: CHD Diabetes Other chronic diseases with conditions prohibiting regular physical activity Drug abuse BMI < 28 or > 35 Regular physical activity Pregnancy Mental illness

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>automated tailored feedback per E-mail | Behavioral: Physical activity<br>* 6-month physical activity intervention (endurance activities) delivered by internet with tailored training schedules<br>|
| Active Comparator: 2<br>1 + active contact per E-mail possible | Behavioral: Physical activity<br>* 6-month physical activity intervention (endurance activities) delivered by internet with tailored training schedules<br>|
| Active Comparator: 3<br>2 + active contact by trainer in case of exercise-related problems | Behavioral: Physical activity<br>* 6-month physical activity intervention (endurance activities) delivered by internet with tailored training schedules<br>|
| Active Comparator: 4<br>3 + regular active contact by trainer | Behavioral: Physical activity<br>* 6-month physical activity intervention (endurance activities) delivered by internet with tailored training schedules<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported physical activity evaluated by questionnaire |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body-Mass-Index |  | 6 months | 
| Body weight |  | 6 months | 
| Technology acceptance evaluated by questionnaire |  | 6 months | 
| Motivation analysis |  | 6 months | 
| Time spent on the internet |  | 6 months | 
| Metabolic equivalents |  | 6 months |