Clinical trial NCT03666481: Physical Activity in Bariatric Patients
Official title: Psychosocial Effects of a Motivational Physical Activity Program in Bariatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Bariatric Surgery Candidate
Keywords: Sleeve gastrectomy
Accelerometer
Exercise
Self-determination theory
Morbid obesity
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Fundacion MAPFRE
name: Universidad Europea de Madrid
First posted: 2018-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in objective physical activity levels.
timeFrame: From before surgery to after the MPAI (7-months post-surgery) and 13, 25 and 37- months post-surgery.
measure: Changes in self-reported physical activity levels.
timeFrame: From before surgery to after the MPAI (7-months post-surgery) and 13, 25 and 37- months post-surgery.
measure: Changes in health-related quality of life.
timeFrame: From before surgery to after the MPAI (7-months post-surgery) and 13, 25 and 37- months post-surgery.
measure: Changes in physical activity motivation.
timeFrame: From before surgery to after the MPAI (7-months post-surgery) and 13, 25 and 37- months post-surgery.
measure: Changes in patients' needs satisfaction in their general life.
timeFrame: From before surgery to after the MPAI (7-months post-surgery) and 13, 25 and 37- months post-surgery.
measure: Measurement of the patients' needs satisfaction in exercise settings.
timeFrame: After the MPAI (7-months post-surgery)
measure: Measurement of the patients' perception of autonomy support provided by instructors.
timeFrame: After the MPAI (7-months post-surgery)
measure: Changes in patients' concerns about their body shape.
timeFrame: From before surgery to after the MPAI (7-months post-surgery) and 13, 25 and 37- months post-surgery.
measure: Changes in patients' self-esteem.
timeFrame: From before surgery to after the MPAI (7-months post-surgery) and 13, 25 and 37- months post-surgery.
measure: Changes in patients' satisfaction with life.
timeFrame: From before surgery to after the MPAI (7-months post-surgery) and 13, 25 and 37- months post-surgery.
measure: Changes in types of motivation in health, leisure and relation activities.
timeFrame: From before surgery to after the MPAI (7-months post-surgery) and 13, 25 and 37- months post-surgery.
Secondary outcomes:
measure: Sex
timeFrame: At baseline (before surgery)
measure: Age
timeFrame: At baseline (before surgery)
measure: Height
timeFrame: At baseline (before surgery)
measure: Weight
timeFrame: Before surgery, after the MPAI (7-months post-surgery) and 13, 25 and 37- months post-surgery.
measure: Educational level
timeFrame: At baseline (before surgery)
measure: Race/ethnicity
timeFrame: At baseline (before surgery)
measure: Marital status
timeFrame: At baseline (before surgery)
measure: Addictive behaviours
timeFrame: At baseline (before surgery)
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Sport Research Center. Miguel Hernández University of Elche.
state: Alicante
Study officials:
affiliation: Sport Research Center. Miguel Hernández University of Elche.
name: David González-Cutre, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.