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The Expressive Writing in Bariatric Surgery

NCT04035512 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2019-07-29

No results posted yet for this study

Summary

The aim of the present study is to test the efficacy of a psychological intervention focused on the expressive writing on the weight loss and adherence, 3 months after surgery in obese population undergoing to bariatric surgery. The sample will be divided into two groups: the expressive writing group that will perform the psychological intervention focused on expressive writing, and the control group that will not perform the psychological intervention. The assignment to the two groups will be randomized. The randomization will be carried out leaving each participant free to blindly choose one of the two sealed envelopes containing the writing instruction sheet and an empty sheet, respectively.

All participants will complete psychometric questionnaires 3 days before surgery (T0) and 3 months (T1) after surgery in order to test the predicted variation on the chosen outcome in a very early stage after surgery. In order to assess the adherence level with a non self - report measure, the serum levels of 25(OH)D, B12, sideraemia and iron at T1 will be collected. Moreover, the adherence to follow up visits (surgical, nutritional and psychological) at 1 and 3 months will be assessed.

The main hypothesis is that those patients undergoing expressive writing would have a greater early Excess Weight Loss % (EWL%), lower level of psychological impairment and higher level of adherence to treatment 3 months after surgery, compare to those patients who are not undergoing expressive writing.

Conditions

  • Bariatric Surgery Candidate

Interventions

OTHER

Expressive writing

The procedure for the writing group will be as follow: on day 1 the researcher will call the participant at designed time and will provide a brief introduction to the writing task. Participant will be asked to go in a quiet place in their house where they would have no interruptions but can still be close to the phone. Next, participants were given standardized instructions. Then participants will ask to start writing immediately after hanging up the phone and to write for 20 minutes. The researcher will call the participants after 20 minutes. The procedure for the second and third writing days will be identical. The above method was previously tested by Zakowski et al., 2004.

Sponsors & Collaborators

  • University College London Hospitals

    collaborator OTHER

  • University of Roma La Sapienza

    lead OTHER

Principal Investigators

  • Gianfranco Silecchia · University of Roma La Sapienza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2020-08-01
Completion
2020-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04035512 on ClinicalTrials.gov