AzTrials
AzTrials

Morbid ObesityPICONCT04282304

Randomised Trial of Intensive Behavioral Lifestyle Intervention Versus Usual Preparation for Bariatric Surgery

A study testing Preoperative intensive behavioral lifestyle intervention in people with Morbid Obesity, run by IHU Strasbourg at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Prospective randomized clinical trial aiming to compare a comprehensive, intensive behavioral lifestyle intervention and usual care during the preoperative preparation to bariatric surgery, with primary outcome on excess weight loss and secondary outcomes on patient's physical status, quality of life, comorbidity and… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Morbid Obesity
What is being tested?
Preoperative intensive behavioral lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteFrance
Study dates
11 Sep 2020to 4 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with a BMI (Body Mass Index) of 40 or BMI of 35 with associated comorbidity and who desires obesity surgery
  • Patient agreeing to participate in the study, including the 2 years follow-up
  • Patient accepting the constraints of the study related to the group to which he/she will be assigned as a result of randomization (availability to his work, his family, etc.)
  • Patient able to receive and to understand the study information and to give written informed consent
  • Patient affiliated with the French social security system

Who cannot join

  • Patient with a BMI of more than 60
  • Patient with contraindication to laparoscopic obesity surgery
  • Patient already operated on for obesity
  • Patient with a history of major abdominal surgery
  • Patient with contraindications to MRI:
  • pace maker or automatic defibrillator, implanted insulin pump
Show all 15Show fewer
  • auditory neurostimulator, anal neurostimulator, etc.
  • ferromagnetic bodies in soft tissues, intraocular foreign bodies, cerebral vascular clips
  • claustrophobia
  • morphotype not allowing access to MRI: morbid obesity with waist circumference greater than 150 cm, shoulder width greater than 59 cm
  • Patient with psychiatric pathology (untreated psychosis, drug dependence, etc.)
  • Pregnant or breast-feeding patient
  • Patient in periods of exclusion (determined by a previous or ongoing study)
  • Patient under safeguard of justice
  • Patient under guardianship

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service de Chirurgie Digestive et Endocrinienne, NHC

    Strasbourg, 67000

Other trials in France

About this study

Official title: Randomised Trial of Comprehensive, Intensive, On-site Behavioural Lifestyle Intervention Versus Usual Care During the Preoperative Preparation for Bariatric Surgery

Prospective randomized clinical trial aiming to compare a comprehensive, intensive behavioral lifestyle intervention and usual care during the preoperative preparation to bariatric surgery, with primary outcome on excess weight loss and secondary outcomes on patient's physical status, quality of life, comorbidity and technical difficulty of the surgery.

Read the detailed description

Obesity is a complex, multifactorial pathology that has major public health importance. Lifestyle modification is the cornerstone of all obesity treatments, including surgery. Throughout the non-surgical treatment options, high-intensity, on-site comprehensive lifestyle intervention has demonstrated the best efficacy in obtaining weight loss, but with a risk of progressive weight regain, after 6 months (1). In obese adults, bariatric surgery produces greater weight loss and weight loss maintenance than the conventional medical treatment and lifestyle intervention (1).

There is no consensus on whether combining these two approaches (i.e. high-intensity, on-site comprehensive lifestyle intervention and bariatric surgery) results in enhanced weight loss or more sustainable outcomes. The present randomized trial aims to answer this question.

Patients preparing for bariatric surgery will be randomized between two groups. The first group will receive the usual care as recommended by the French Health Authority ("Haute Autorité de santé"), including 6 months of endocrine and nutritional follow-up and educational intervention. The second group will receive a high-intensity, 4 weeks on-site comprehensive lifestyle intervention, including prescription of a moderately reduced-calorie diet, a program of increased physical activity, and behavioral management. The patients from both groups will then be operated on and followed for at least 2 years. Complete work-up, including clinical examination, comorbidity assessment, MRI of the liver, thigh and abdominal fat, 6 minutes' walk test, quality of life questionnaires will be performed at the begging of the follow-up, after the preparation (usual care or intensive) and 2 years after surgery. Clinical and biological assessment will be performed regularly after surgery, and technical details from the bariatric interventions will be analyzed in order to assess the eventual facilitation of the gestures in the intervention group.

Conditions
Morbid Obesity
Being tested
Preoperative usual care, Preoperative intensive behavioral lifestyle intervention
Keywords
Behavioral intervention, Severe obesity, Weight loss, Bariatric surgery
Medical subject headings
Obesity, Morbid, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative usual careBehavioural

    Usual care during the preoperative preparation for bariatric surgery consists of:

    • Endocrinologist work-up and follow-up, with at least 2 consultations;
    • Dietary advice, provided during the endocrine consultation or dietician consultation
    • Psychological counselling with the patient's usual psychiatrist (at least 2 consultations
    • Physical activity and nutrition are encouraged, but entrusted to the patient's freedom of choice. Weight loss, or at least, weight stabilization, is recommended before the surgery, without initiating a specific behavioural procedure.

  • Preoperative intensive behavioral lifestyle interventionBehavioural

    The intensive behavioral lifestyle intervention program takes place over 4 weeks of 5 days. It includes:

    • Rehabilitation to physical exercise every morning
    • Therapeutic cooking sessions; during these sessions, the patients prepare the day's meals under the supervision of a nutritionist
    • Psychological counselling
    • One swimming session per week
    • One relaxation session
    • Regular physical activity (aerobics, work-up)
    • Individual entertainment with the physiotherapist physician and discussion groups
    • Weight, BMI and waist circumference control at the end of each week.
Study groups in NCT04282304
Study groupRoleWhat they receive
Usual CareOtherThe patients in this arm will have usual care during preoperative period, bariatric surgery and follow-up.
Receives: Behavioral: Preoperative usual care
UGECAMExperimentalDuring the preoperative period, the patients in this arm will have usual care and a 4 weeks intensive, comprehensive behavioral lifestyle intervention. They will then have usual bariatric surgery and follow-up.
Receives: Behavioral: Preoperative intensive behavioral lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in body weight

    Changes in body weight

    Measured: Before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery

  2. Excess weight loss

    The percentage of excess weight loss is obtained as follow:

    (initial body weight - body weight at 2 years postoperatively) / (initial body weight - ideal body weight at BMI 25) x 100

    Measured: 2 years after surgery

  3. Changes in Body Mass Index (BMI)

    Changes in Body Mass Index, obtained as follow:

    body weight (in kilograms)/ the square of height (in meters)

    Measured: Before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery

Secondary outcomes (17)

  1. Changes in the physical status in terms of muscle/fat report

    Muscle/ Fat Cross Sectional Area report obtained by the mean of Magnetic Resonance Imaging (MRI)

    Measured: Before preparation, before surgery and 24 months after surgery

  2. Changes in the physical status in terms of walking abilities

    Changes in 6-min walk test: the distance (in meters) that the patient is able to walk in 6 minutes

    Measured: before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery

  3. Changes in the physical status in terms of waist circumference

    Changes in waist circumference measured in centimetres

    Measured: before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery

  4. Changes in physical status in terms of hip circumference

    Changes in hip circumference measured in centimetres

    Measured: before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery

  5. Changes in surgical difficulty in terms of left liver volume

    Left liver volume, as measured by Magnetic Resonance Imaging (MRI)

    Measured: Before preparation, before surgery and 24 months after surgery

  6. Changes in surgical difficulty in terms of visceral flat volume

    Visceral Fat volume, as measured by Magnetic Resonance Imaging (MRI) on a 1 cm slide at L2-L3 level

    Measured: Before preparation, before surgery and 24 months after surgery

  7. Comparison of surgical difficulty in terms of surgery duration

    Total duration of Surgery, in minutes, for each group

    Measured: At time of surgery

  8. Comparison of surgical difficulty in terms of gastric pouch positioning duration

    Time from trocar positioning to fashioning the gastric pouch, in minutes, for each group

    Measured: At time of surgery

  9. Comparison of surgical difficulty in terms of postoperative hospitalisation duration

    Duration of the hospitalisation stay after the surgery, in days, for each group

    Measured: At time of surgery

  10. Changes in the quality of life by the mean of the Gastrointestinal Quality of Life Index (GIQLI)

    The GIQLI (Gastrointestinal Quality of Life Index) questionnaire is a digestive quality of life score including 36 items dealing with symptoms, physical status, emotions, social problems, and the effect of medical treatment in relation with gastro-intestinal disorders or procedures. The score is between 0 and 144, the higher the score, the better the quality of life.

    Measured: before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery

  11. Changes in the quality of life by the mean of a quality of life questionnaire specialized in bariatric surgery

    "Moorehead-Ardelt Quality of Life Questionnaire II" (M-A-QoLQII) was originally designed as a disease-specific instrument to measure postoperative outcomes of self-perceived QoL in obese patients. Six areas are examined: self-esteem, physical well-being, social relationships, work, sexuality, and eating behavior. Each item is evaluated on a 10-point scale and scored from -0.5 to +0.5. The higher the score, the better the quality of life.

    Measured: before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery

  12. Changes in the remission rate of fatty liver

    the remission rate of the fatty liver is assessed by MRI (Magnetic Resonance Imaging) which provides measurements of the liver fatty infiltration

    Measured: Before preparation, before surgery and 24 months after surgery

  13. Changes in liver elasticity

    The liver elasticity is assessed by Magnetic Resonance Elastography (MRE) which provides quantitative maps of its stiffness

    Measured: Before preparation, before surgery and 24 months after surgery

  14. Changes in iron overload in the liver

    The iron overload in the liver is assessed through Magnetic Resonance Imaging (MRI) measurement of the tissue relaxivity in T2 phase

    Measured: Before preparation, before surgery and 24 months after surgery

  15. Changes in LDL cholesterol levels

    Changes in LDL cholesterol levels (grams per liter)

    Measured: Before preparation, before surgery and 24 months after surgery

  16. Changes in insulin resistance

    Changes in Homeostatic Model Assessment of Insulin Resistance(HOMA-IR) levels is calculated as follow:

    HOMA - IR = Insulin x Glucose / 22.5

    Measured: Before preparation, before surgery and 24 months after surgery

  17. Surgical complication assessment

    percentage of patients presenting a complication

    Measured: Up to 24 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2020
  2. Study start11 Sep 2020
  3. Primary completion4 Apr 2025
  4. Study completion4 Apr 2025

Why it stopped: Premature termination due to lack of inclusion. Behavioral preparation is perceived as too restrictive by patients. Furthermore, the Covid and post-covid period has drastically restricted the possibilities of support for behavioral preparation.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, controlled, open-label study
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04282304
Sponsor's protocol ID
19-006
Acronym
PICO
Status last verified
Apr 2025
First submitted
18 Feb 2020
Last updated
1 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.

    PubMed 24239920

  • Yang YX, Chong MS, Lim WS, Tay L, Yew S, Yeo A, Tan CH. Validity of estimating muscle and fat volume from a single MRI section in older adults with sarcopenia and sarcopenic obesity. Clin Radiol. 2017 May;72(5):427.e9-427.e14. doi: 10.1016/j.crad.2016.12.011. Epub 2017 Jan 20.

    PubMed 28117037

  • Maislin G, Ahmed MM, Gooneratne N, Thorne-Fitzgerald M, Kim C, Teff K, Arnardottir ES, Benediktsdottir B, Einarsdottir H, Juliusson S, Pack AI, Gislason T, Schwab RJ. Single slice vs. volumetric MR assessment of visceral adipose tissue: reliability and validity among the overweight and obese. Obesity (Silver Spring). 2012 Oct;20(10):2124-32. doi: 10.1038/oby.2012.53. Epub 2012 Mar 7.

    PubMed 22395811

  • Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229.

    PubMed 7749697

  • Moorehead MK, Ardelt-Gattinger E, Lechner H, Oria HE. The validation of the Moorehead-Ardelt Quality of Life Questionnaire II. Obes Surg. 2003 Oct;13(5):684-92. doi: 10.1381/096089203322509237.

    PubMed 14627461

Questions about this trial

What is this clinical trial studying?

A study testing Preoperative intensive behavioral lifestyle intervention in people with Morbid Obesity, run by IHU Strasbourg at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Premature termination due to lack of inclusion. Behavioral preparation is perceived as too restrictive by patients. Furthermore, the Covid and post-covid period has drastically restricted the possibilities of support for behavioral preparation.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in body weight (time frame: Before preparation, before surgery, and at 1 month, 3 months, 6 months, 12 months and 24 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04282304, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in