APOLO-Bari: an internet program for supporting of bariatric surgery patients

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN37668662
• Date of registration: 18/09/2015
• Prospective Registration: Yes
• Primary sponsor: University of Minho
• Public title: APOLO-Bari: an internet program for supporting of bariatric surgery patients
• Scientific title: APOLO-Bari: an internet-based program for longitudinal support of bariatric surgery patients. A multicenter randomized controlled trial
• Date of first enrolment: 04/02/2016
• Target sample size: 180
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN37668662
• Study type: Interventional
• Study design: Randomized controlled trial (Other)

Countries of recruitment

Portugal

Contacts

• Name: Eva Conceicao

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years old
2. Underwent bariatric surgery more than 12 months before recruitment
3. Patients with significant post-operative weight loss (% excessive weight loss > 30%).
Exclusion criteria: 1. Participants presenting significant weight regain (> than 15% of total weight loss) since nadir weight at the time of registration
2. No regular internet access
3. Inability to read and understand Portuguese instructions
4. Unwillingness to have/create and email account
5. Presence of active psychiatric disorder (e.g. bipolar disorder; psychotic disorder; suicidal ideation; eating disorders)
6. Intake of weight-affecting drugs
7. Concomitant weight loss treatment besides TAU
8. Pregnancy or lactation in female participants

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Obsesity
Nutritional, Metabolic, Endocrine
Obsesity

Intervention(s)

Those accepting entering the study will have a computer connected to the internet to their availability to accept the informed consent form online and register by creating a personal username and password. All participants respond an initial short socio-demographic and clinical questionnaire. To ensure the concealment of allocation, the system will then automatically randomize participants on a 1:1 basis, matching for age, gender and surgery type.

Intervention Group (IGroup): Receives full access to the the 3 components of APOLO-Bari program in their personal account. Intervention will last for 12 months and a 12 months period follows with no access possible to the program. During the intervention period the system will record data on login frequency, task submission and weekly monitoring from IGroup. The program includes three different components:
1. The self-help manual psycho-educational cognitive-behavioral based which includes information on different topics relevant for weight regain prevention, and tasks related to the different topic
2. The weekly feedback message system (FMS) with immediate feedback response which assesses risk behaviors, sending a feedback statement that relates to the information reported by the participant and his/hers historical reports, reinforcing and guiding when a problem is detected
3. Direct contact with a trained psychologist in the field through scheduled interactive chat sessions, where participants can pose personal questions.

Control Group (CGroup): Has only access to general information on obesity and bariatric surgery, and to the set of self-report measures at the different assessment times described below. CGroup participants will be informed about the assessment times and the possibility of accessing the full program after the study complete.

Both groups receive reminding messages in their email addresses every time a questionnaire/activity is available. Both groups will complete a similar set of questionnaires at

Primary Outcome(s)

1. Weight regain assessed at baseline, end of intervention and at follow up. Weight is measured in the presence of a research member with a TANITA scale.
2. Variant of weight loss estimations using percentage of total weight regain, percentage of excessive weight regain, percentage of total weight loss and percentage of excessive weight loss formulas.

Secondary Outcome(s)

1. Behavioral outcomes assessed weekly for one year during intervention as part of the monitoring feedback system of APOLO-Bari, using with a short self-report measure developed for this purpose: number of days with maladaptive eating behaviors (such as grazing, binge eating and overeating episodes), number of hours of sedentary and physical activities in the previous month
2, Psychological outcomes assessed with self-report measures at baseline (Tb), midterm (Tm4 and Tm8), end of treatment (Tf) and follow-up (Tfu6 and Tfu12) using the Eating disorder-15 questionnaire assessing eating disorder psychopathology, repetitive rating questionnaire to assess grazing, depression anxiety stress scale and negative urgency subscale to assess impulsivity.

Secondary ID(s)

PTDC/MHC-PCL/4974/2012

Source(s) of Monetary Support

Foundation for Science and Technology