En_Línea. An Online Treatment to Change Lifestyle in Overweight and Obesity: Study Protocol for a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overweight
- Sponsor
- University of Barcelona
- Enrollment
- 305
- Locations
- 1
- Primary Endpoint
- Maintenance of weight loss 6 months follow-up
- Last Updated
- 6 years ago
Overview
Brief Summary
A randomized controlled trial to test the effectiveness of an online weight control program, called en_línea, comparing with a standard group therapy and a control group
Detailed Description
This is a randomized controlled trial with three intervention arms: en_línea, standard group therapy and control group. To perform this study, 305 adults (18-65 years) with overweight type II (27-29.9 kg/m2) or obesity type I (30-34.9 kg/m2) will be invited to participate. Interventions will last 17 weeks with follow-ups 1, 3, 6 and 12 months after the post-treatment appointment. The primary outcome will be post-treatment weight loss and the maintenance during the follow-ups. Secondary outcomes will be adherence rates, drop outs and quality of life. Participants will be assessed before randomization and they will be sign an inform consent.
Investigators
Carmina Saldaña
PhD
University of Barcelona
Eligibility Criteria
Inclusion Criteria
- •Overweight type II or obesity type I. BMI between 27 and 34.9 kg/m2
- •Age between 18 and 65 years old
- •Compliance with all evaluation phases.
Exclusion Criteria
- •Presence of several physical disease, i.e. diabetes, hypertension, cancer or metabolic disorders
- •Presence of several psychological problem, i.e. depression, anxiety
- •Presence of other eating disorders, i.e. anorexia nervosa, bulimia nervosa, binge eating disorders
- •Use of drugs, i.e. slimming, anovulatory or psychotropic
- •Pregnancy or planned pregnancy for the next six months
- •Following another weight control program at the time of selection.
Outcomes
Primary Outcomes
Maintenance of weight loss 6 months follow-up
Time Frame: 6 months follow-up
Maintenance of weight loss
Weight loss
Time Frame: 4 months
5%-10% of weight loss respect the initial weight
Maintenance of weight loss 1 month follow-up
Time Frame: 1 month follow-up
Maintenance of weight loss
Maintenance of weight loss 3 months follow-up
Time Frame: 3 months follow-up
Maintenance of weight loss
Maintenance of weight loss 12 months follow-up
Time Frame: 12 months follow-up
Maintenance of weight loss
Secondary Outcomes
- Adherence(4 months)
- Drop out(4 months)
- Quality of life test measures(4 months)