Overweight, Obesity
Conditions
Keywords
online therapy, weight loss control program, Internet
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.
Interventions
BEHAVIORALen_línea
This is an online adaptation of the LEARN program. A self-help weight control program developed by Kelly Brownell in 2004.
BEHAVIORALGroup therapy
This is a traditional behavioral weight control program
Sponsors
University of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Overweight type II or obesity type I. BMI between 27 and 34.9 kg/m2 2. Age between 18 and 65 years old 3. Compliance with all evaluation phases.
Exclusion criteria
1. Presence of several physical disease, i.e. diabetes, hypertension, cancer or metabolic disorders 2. Presence of several psychological problem, i.e. depression, anxiety 3. Presence of other eating disorders, i.e. anorexia nervosa, bulimia nervosa, binge eating disorders 4. Use of drugs, i.e. slimming, anovulatory or psychotropic 5. Pregnancy or planned pregnancy for the next six months 6. Following another weight control program at the time of selection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of weight loss 12 months follow-up | 12 months follow-up | Maintenance of weight loss |
| Maintenance of weight loss 1 month follow-up | 1 month follow-up | Maintenance of weight loss |
| Maintenance of weight loss 3 months follow-up | 3 months follow-up | Maintenance of weight loss |
| Maintenance of weight loss 6 months follow-up | 6 months follow-up | Maintenance of weight loss |
| Weight loss | 4 months | 5%-10% of weight loss respect the initial weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drop out | 4 months | Percentage of participants who finish the treatment |
| Quality of life test measures | 4 months | Questionnaire of Quality of Life provided by the LEARN program |
| Adherence | 4 months | 80% of completed website activities and 80% of self-records |
Countries
Spain
Contacts
Primary ContactCarmina Saldaña, PhD
Outcome results
None listed