Condition category
Nutritional, Metabolic, Endocrine
Date applied
01/12/2018
Date assigned
27/03/2019
Last edited
27/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Bariatric surgery is surgery to increase weight loss in obese people. This includes gastric band and gastric sleeve surgery, in which the size of the stomach is reduced so that it can only handle small amounts of food eaten slowly. Weight loss after bariatric (obesity) surgery can be hampered by unhealthy behaviors such as poor diet and physical inactivity. The aims of the study were to investigate how well a motivational, nutritional and exercise program works in terms of improving weight loss and physical condition in patients after surgery.

Who can participate?
Adults who had had gastric band or gastric sleeve surgery in the previous 1-6 months.

What does the study involve?
Participants who chose to take part in the activities had monthly motivational group meetings with a psychologist, monthly nutritional group meetings with a dietician, and twice-weekly group sessions of adapted exercise guided by exercise professionals. Weight, body measurements, diet, attitudes towards food, physical activity and quality of life, and physical strength and range of movement were measured before the start of the program, at the end of the program (1 year later) and at follow-up (2 years after the start of the program). Patients who agreed to participate in the study but were unable to take part in the activities provided the same information.

What are the possible benefits and risks of participating?
The treatment was educational and motivational. Physical activity protocols were personalized to each patient to avoid any possible risk. Participants might improve their health and speed up their weight loss.

Where is the study run from?
University of Naples Parthenope (Italy)

When is the study starting and how long is it expected to run for?
September 2015 to November 2017

Who is funding the study?
The University of Naples Parthenope

Who is the main contact?
Francesca Gallè, francesca.galle@uniparthenope.it


Trial website

Contact information

Type

Public

Primary contact

Prof Giorgio Liguori

ORCID ID

http://orcid.org/0000-0002-5962-9976

Contact details

Via Medina 40
Naples
80133
Italy
+39815474690
giorgio.liguori@uniparthenope.it

Type

Scientific

Additional contact

Prof Francesca Gallè

ORCID ID

http://orcid.org/0000-0002-0504-9562

Contact details

Via Medina 40
Naples
80133
Italy
+39815474669
francesca.galle@uniparthenope.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Lifestyle Intervention after Obesity Surgery (LIOS): Educational and motivational exercise-based program to improve surgery outcomes in bariatric patients.

Acronym

LIOS

Study hypothesis

A multidisciplinary lifestyle intervention may prevent weight regain and improve health and quality of life in bariatric patients

Ethics approval

Institutional Board of the Department of Movement Sciences and Wellbeing of the University of Naples Parthenope and of the Hospital Villa Betania in Naples, 18/12/2014, ref 998/2014)

Study design

Single-centre interventional controlled non-randomized study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Obesity

Intervention

The structured intervention lasted 12 months and included a motivational program, a nutritional program and an exercise program.
1.The motivational program was carried out through periodical series of bi-weekly group meetings lasting 90 minutes and guided by a psychologist with expertise on motivational interviewing for behavior change. The first sessions were focused on the reciprocal introduction of participants and on their readiness for change; subsequently their knowledge, attitudes and beliefs regarding physical activity and diet were explored.
2. The nutritional program was conducted through monthly group meetings lasting 90 minutes with a trained nutritionist. It was structured in a first phase aimed to investigate the nutritional habits of participants and in a subsequent intervention including the discussion of the effects of diet on weight management and the suggestion of healthy food choices and solutions to manage nutrition through an adequate daily distribution of meals and nutrients.
3. The exercise program was provided through one-hour training group sessions performed two times per week on non-consecutive days and guided by exercise professionals. Training was adapted to participants’ conditions and periodically modified based on their advances. It included moderate-to-vigorous aerobic and resistance exercises.
All the activities were performed in the same facility and by the same operators throughout the whole intervention.
The protocol for control patients consisted of a meeting with their bariatric surgeon at 12 months after surgery.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Weight at at the start of the intervention (0 months), the end of the intervention (12 months) and at follow-up (24 months)

Secondary outcome measures

1. Food choices and dietary patterns were estimated by asking participants to record the type and amount of food and beverage consumed for 7 days before
2. Eating behaviors and feeling/cognitions regarding binge eating episodes were explored through the 16-item Binge Eating Scale
3. Quality of life and attitudes towards physical activity assessed using Obesity-Related WELL-being questionnaire (ORWELL-97)
4. Physical fitness assessed using squat test, dynamometer for grip strength, and Rockport walking test
5. Posture assessed using carbon paper
6. Functional disabilities assessed using the Oswestry Low Back Pain Disability Questionnaire
7. Body mass index calculated from weight and height measurements
8. Waist and hip circumference assessed using carbon paper
9. Articular range of motion assessed using a medical goniometer
All outcome measures were recorded at the start of the intervention (0 months), the end of the intervention (12 months) and at follow-up (24 months)

Overall trial start date

01/09/2015

Overall trial end date

30/11/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Undergoing first bariatric surgery (laparoscopic sleeve gastrectomy or laparoscopic adjustable gastric banding)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Substance dependence
2. Current treatment for psychiatric/psychological disorders
3. Physical unsuitability

Recruitment start date

01/11/2015

Recruitment end date

30/11/2015

Locations

Countries of recruitment

Italy

Trial participating centre

Hospital Villa Betania
Via Argine
Naples
80147
Italy

Sponsor information

Organisation

University of Naples Parthenope, Department of Movement Sciences and Wellbeing

Sponsor details

Via Medina 40
Naples
80133
Italy

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Naples Parthenope

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of the results in high-impact peer-reviewed international journals in 2019.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon detailed and well-motivated request to the representatives of the study. They will be shared in an aggregate form, respecting the anonymity guaranteed to the participants through the informed consent.

Intention to publish date

31/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes