Physical Activity in Bariatric Patients

NCT ID: NCT03666481

Last Updated: 2018-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-16

Study Completion Date

2015-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the current study was to explore the effect of a 6-months motivational physical activity intervention (MPAI) on different psychosocial variables (e.g. motivation, health-related quality of life, self-esteem, etc.) and on the physical activity levels of bariatric surgery patients. Comparing with a control group (CG), we tested the differences obtained on these variables between before surgery and just after the MPAI (7-months after surgery). Additionally, we explored the (possible) prolonged effects of the intervention by doing re-tests 13, 25 and 37- months after surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants were recruited from a Spanish hospital between November 2011 and May 2013. Through their pre-operative visit to the clinical psychologist, patients were asked if they wanted to participate in a follow-up intervention to measure their physical activity (PA) levels and various psychological variables related to exercise. Participants who showed interest after this interview were subsequently contacted by phone to arrange a baseline visit to the sport research center, during which they were informed about the aims and procedure of the study, provided written consent, and completed questionnaires to assess different variables related to psychosocial aspects. Moreover, participants were asked to wear an accelerometer at their right hip for one week, warning them to take it off just to sleep, shower, or to perform activities that could damage the device (e.g. swimming). When they returned, they were assigned to a motivational PA intervention (MPAI) or control (CG) group.

At post-intervention measurements, patients again completed all questionnaires and wore an accelerometer during another week.

Regarding the MPAI, it was carried out during 6 consecutive months and took place in a public fitness center. The sessions were directed by exercise and sport sciences professionals (Degree in sport sciences, Master's degree in PA and health), who were trained in the application of motivational strategies based on self-determination theory (SDT). According with the postulates of SDT, these motivational strategies would help to enhance the satisfaction of basic psychological needs that are necessary for optimal development and functioning, such as competence, autonomy, relatedness and novelty. So, in the context of exercise, intrinsic forms of motivation will appear in people if basic psychological needs are satisfied, which will lead to positive consequences related to enjoyment, adherence, and positive attitudes towards PA.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Morbid Obesity Bariatric Surgery Candidate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MPAI group

Patients in this group participated in a 6-months Motivational Physical Activity Intervention (MPAI) to explore its effects on different variables related to PA levels and psychosocial aspects of life of bariatric patients. Concretely, the fundamental goals of the MPAI group were three: to increase the self-determined forms of motivation of the patients towards exercise or reduce those related to non-self-determined motivation; to improve post-operative levels of PA with respect to pre-operative levels, and; transfer the benefits of the intervention on different variables related to the perceived health-related quality of life.

Group Type EXPERIMENTAL

Motivational Physical Activity Intervention (MPAI)

Intervention Type BEHAVIORAL

MPAI was carried out during 6 consecutive months. The sessions were directed by sport sciences professionals, who were trained in the application of motivational strategies based on self-determination theory.

The frequency of training, as well as the duration of the sessions, was increasing throughout the 6 months. The contents of the sessions could be directed in two ways: sessions with activities to develop cardiorespiratory fitness and muscular strength, and playful sessions to enhance psychosocial aspects. Nevertheless, motivational strategies were implemented in both types of sessions.

Control group

Patients in this group did not participate in any intervention, but the same measurements were made in them as in the MPAI group in the same temporal spaces.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Motivational Physical Activity Intervention (MPAI)

MPAI was carried out during 6 consecutive months. The sessions were directed by sport sciences professionals, who were trained in the application of motivational strategies based on self-determination theory.

The frequency of training, as well as the duration of the sessions, was increasing throughout the 6 months. The contents of the sessions could be directed in two ways: sessions with activities to develop cardiorespiratory fitness and muscular strength, and playful sessions to enhance psychosocial aspects. Nevertheless, motivational strategies were implemented in both types of sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* To have a BMI greater than 40kg/m2 or greater than 35kg/m2 with an associated comorbidity.
* To have experienced previous failed obesity treatments with restrictive-caloric diets and medications.
* To have followed endocrinology and nutritional monitoring, accomplishing the therapeutic instructions properly.
* To have no medical, psychological or social contraindications.
* To have the consent of the clinical psychiatrist and the surgeon and ensure their willingness to attend the programme.

Exclusion Criteria

* To participate in another physical activity or weight loss program
* Not ensuring full availability to attend the program
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fundacion MAPFRE

OTHER

Sponsor Role collaborator

Universidad Europea de Madrid

OTHER

Sponsor Role collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David González-Cutre Coll

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David González-Cutre, PhD

Role: PRINCIPAL_INVESTIGATOR

Sport Research Center. Miguel Hernández University of Elche.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sport Research Center. Miguel Hernández University of Elche.

Elche, Alicante, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Bond DS, Vithiananthan S, Thomas JG, Trautvetter J, Unick JL, Jakicic JM, Pohl D, Ryder BA, Roye GD, Sax HC, Wing RR. Bari-Active: a randomized controlled trial of a preoperative intervention to increase physical activity in bariatric surgery patients. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):169-77. doi: 10.1016/j.soard.2014.07.010. Epub 2014 Jul 30.

Reference Type RESULT
PMID: 25304832 (View on PubMed)

Bond DS, Graham Thomas J, Vithiananthan S, Webster J, Unick J, Ryder BA, Pohl D. Changes in enjoyment, self-efficacy, and motivation during a randomized trial to promote habitual physical activity adoption in bariatric surgery patients. Surg Obes Relat Dis. 2016 Jun;12(5):1072-1079. doi: 10.1016/j.soard.2016.02.009. Epub 2016 Feb 17.

Reference Type RESULT
PMID: 27246138 (View on PubMed)

Berglind D, Willmer M, Eriksson U, Thorell A, Sundbom M, Udden J, Raoof M, Hedberg J, Tynelius P, Naslund E, Rasmussen F. Longitudinal assessment of physical activity in women undergoing Roux-en-Y gastric bypass. Obes Surg. 2015 Jan;25(1):119-25. doi: 10.1007/s11695-014-1331-x.

Reference Type RESULT
PMID: 24934315 (View on PubMed)

Berglind D, Willmer M, Tynelius P, Ghaderi A, Naslund E, Rasmussen F. Accelerometer-Measured Versus Self-Reported Physical Activity Levels and Sedentary Behavior in Women Before and 9 Months After Roux-en-Y Gastric Bypass. Obes Surg. 2016 Jul;26(7):1463-70. doi: 10.1007/s11695-015-1971-5.

Reference Type RESULT
PMID: 26613756 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UEM2.11X

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.