Effects of Technology-based Physical Activity Interventions for Women After Bariatric Surgery

Bariatric Surgery Candidate Clinical Trial

— OCAPAS  

Official title:

Effects of Technology-based Physical Activity Interventions for Women After Bariatric Surgery: a Three-arm Randomized Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04478331
• Other study ID #: IDRCB: 2020.A00172-37
• Secondary ID: ANR-15-IDEX-01
• Status: Recruiting
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: April 2022

Study information

• Verified date: November 2020
• Source: Universite Cote d'Azur
• Contact: Fabienne d'Arripe-Longueville, Pr
• Phone: 762485953
• Email: fabienne.d-arripe-longueville[@]univ-cotedazur.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Regular physical activity (PA) is essential throughout bariatric surgery (BS) management, especially for the long-term maintenance of weight loss. To optimize physical activity counseling and monitoring, the use of technology seems appropriate and effective. A recent meta-analysis provided proof of efficacy for mobile technology to increase physical activity or weight loss in the short term. Videoconferencing may also be effective, especially as it reduces the barriers related to face-to-face physical activity interventions. Both technologies (mobile and videoconferencing) seem particularly interesting for bariatric surgery management, but their long-term effects on physical activity maintenance are unknown. Moreover, the mechanisms underlying their effectiveness, such as technology acceptability and motivational processes, have not been examined.

The purpose of this study is to determine the effects of two technology-based (mobile technology and videoconferencing) PA programs after BS compared to standard care and to assess the contribution of acceptability and motivational mechanisms in explaining these effects on behavioral measure of PA, physical measures, and health indicators.

One hundred and twenty young women who have undergone BS in the last 3 to 6 months will be included. The volunteers will be randomly assigned to one of three arms: standard care (CONTROL), access to an internet-based physical activity program delivered by an eHealth platform associated with an activity bracelet (ACTI-MOBIL), or access to a physical activity program delivered via videoconferencing (ACTI-VISIO). The primary outcome is the distance traveled during a 6-minute walk test relativized according to Capadaglio's theoretical distance. Secondary outcomes are behavioral measures of physical activity, physical measures, health indicators, technology acceptability, and motivational concepts. Data will be collected baseline (T0), 3 months (T3) and 6 months later (T6). The technology groups will receive a PA program for 12 weeks (between T0 and T3). A mixed model approach will be used to analyze the change in outcomes over time for each group.

This study will provide information on the effects of two technology-based physical activity programs (mobile technology and videoconferencing) after bariatric surgery. Based on the results, recommendations for implementing these programs will be made.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Undergone bariatric surgery at a tertial referral center for bariatric surgery (Nice University Hospital, France) 3 to 6 months ago

• Respect with the national recommendations (e.g., BMI = 40kg/m² or = 35kg/m² with at least one co-morbidity among blood hypertension, type 2 diabetes, invalidating arthritis, and sleep apnea syndrome; and no physical disability to practice PA)

• Having a smartphone compatible with the proposed technologies.

Exclusion Criteria:

• Serious adverse events

• Withdrawal of informed consent or violation of the protocol

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

Behavioral:
• Technology-based physical activity interventions
The technology groups will receive a PA program for 12 weeks. These PA programs will be given twice a week and include: 5-10 minutes of warm-up, 20-40 minutes of aerobic exercise and muscle strengthening via circuit training composed of 8-10 exercises with 8-12 repetitions per exercise for 2-3 series, and 5-10 minutes of stretching. In addition, advice and counseling will be given about walking activities to achieve the recommendations.

Locations

Country	Name	City	State
France	Centre Spécialisé Obésité	Nice

Sponsors (3)

Lead Sponsor	Collaborator
Pr Fabienne d'Arripe-Longueville	Association Azur Sport Santé, Nice, France, Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of technology acceptability	Measured only in the technologies groups (ACTI-MOBIL, ACTI-VISIO) by the French eHealth acceptability scale (Hayotte et al., 2020). This scale includes 22 items divided into seven subscales: performance expectancy, effort expectancy, social influence, facilitating conditions, hedonic motivation, price value, and habit. Behavioral intention will also be measured using the French translation described in the French eHealth acceptability scale (Hayotte et al., 2020). Participants will rate each item on a 7-point scale ranging from 1: "strongly disagree" to 7: "strongly agree." Higher scores indicating better technology acceptability.	Baseline (T0), 3 months (T3), and 6 months (T6)
Other	Program compliance	To measure technology-based program compliance, companies will be asked to report the presence or absence of women and their RPE at each session in a register (directly reported by the PA professional for ACTI-VISIO; completion, content consultation and validation statistics, PA level and number of days the activity bracelet is worn for ACTI-MOBIL).	3 months (T3)
Other	Change of motivation for physical activity	The motivation for health-oriented PA will be measured with a French motivation scale for health-oriented PA (Boiché et al., 2016). This scale comprises 18 items, equally distributed across the six motivational constructs of self-determination theory: intrinsic motivation, integrated regulation, identified regulation, introjected regulation, external regulation, and amotivation. Participants will respond on a 7-point Likert scale ranging from 1: "strongly disagree" to 7: "strongly agree." Higher scores indicating the most predominant type of motivation on the self-determination continuum.	Baseline (T0), 3 months (T3), and 6 months (T6)
Other	Change of general causality orientations scale for physical activity	Causality orientations will be measured using an adaptation of the General Causality Orientations Scale (Vallerand et al., 1987) to assess the strength of three motivational orientations (i.e., autonomy, control, impersonal) in the context of PA in a medical environment. The scale comprises seven vignettes and 21 items. Each vignette describes a situation and is followed by three items, one per motivational orientation, to which participants respond on a 7-point scale ranging from 1: "strongly disagree" to 7: "strongly agree." The higher scores indicating the most predominant type of causality orientation.	Baseline (T0), 3 months (T3), and 6 months (T6)
Other	Change of basic psychological needs	Basic psychological needs will be measured using a French scale validated in the sports context (Gillet et al., 2008) where we replaced "sport" by "physical activity." This scale comprises 15 items distributed across the three needs: autonomy, competence, and relatedness. Participants will respond on a 7-point Likert scale ranging from 1: "strongly disagree" to 7: "strongly agree." The higher scores indicating the most predominant type of basic psychological needs.	Baseline (T0), 3 months (T3), and 6 months (T6)
Primary	Change of functional capacity calculated by the percentage achievement of the theoretical distance calculated by the Capodaglio's (2013) formula	We will aggregate the following primary outcome measures into the Capodaglio (2013) formula: 894.2177 - (2.0700 x age(years)) - (51.4489 x 1) - 5.1663 x BMI (kg/m²) to obtain the theoretical distance, and we will calculate the percentage achievement of this theoretical distance: ((distance traveled(meters) - theoretical distance(meters)) / theoretical distance(meters))x100.; Higher percentage of achievement reflecting higher functional capacity.	Baseline (T0), 3 months (T3), and 6 months (T6)
Primary	Change of distance traveled during a six-minute walk test (6MWT)	Distance traveled during a six-minute walk test (6MWT) will be expressed in meters	Baseline (T0), 3 months (T3), and 6 months (T6)
Primary	Change of body mass	Kilograms	Baseline (T0), 3 months (T3), and 6 months (T6)
Primary	Height	Meters	Baseline (T0)
Primary	Date of birth	The date of birth will be requested once (pre-bariatric surgery) and will be used to calculate the age in years at the different periods needed to calculate the theoretical 6MWT distance	Baseline (T0)
Secondary	Change of subjective physical activity level	Global Physical Activity Questionnaire validated in the French language (Rivière et al., 2018). This scale comprises 16 items to assess the frequency and duration of PA during work, transportation, leisure time, and time spent sitting in a typical week. The items are used to calculate the energy expenditure score in metabolic equivalent tasks (METs), where 150 minutes per week of moderate to vigorous PA corresponds to 600 MET-min/week.	Baseline (T0), 3 months (T3), and 6 months (T6)
Secondary	Change of objective physical activity level	Axivity AX3 triaxial accelerometer worn on the wrist during 7-day period. The sensor will be set to begin recording at midnight the day after the appointment over a 7-day period at 100 Hz with a dynamic range of ±8g. The AX3 data will be downloaded, resampled, calibrated and analyzed using open-source AX3 OmGui software (OmGui Version 1.0.0.43, Open Movement, Newcastle University, UK).	Baseline (T0), 3 months (T3), and 6 months (T6)
Secondary	Change of stage of change for physical activity	Stage of Change for physical activity will be measured using the French version of the Stages of Change questionnaire (Romain et al., 2012). Regular PA and exercise are defined as "at least 30 minutes per session, at least 5 days per week of moderate to vigorous PA." This questionnaire includes five items with a "yes" or "no" answer, transformed by an algorithm to attribute a score to each participant according to her stage (precontemplation=1, contemplation=2, preparation=3, action=4 or maintenance stage=5).	Baseline (T0), 3 months (T3), and 6 months (T6)
Secondary	Change of energetic consumption measured during the 6MWT	The physiological variables will be measured during the 6MWT: oxygen uptake, minute ventilation, carbon dioxide output, respiratory exchange ratio, and heart rate, using the Cosmed K5 system (Cosmed K5, Rome, Italy), which consists of a mask and a portable unit. A decrease in energetic consumption for the same distance travelled during the 6MWT reflecting a better adaptation to exercise.	Baseline (T0), 3 months (T3), and 6 months (T6)
Secondary	Change of muscle strength	The maximal isometric knee extensor muscles' strength of the left and right lower limb will be measured with the MicroFET2 (Hoggan Scientific, LLC, Salt Lake City, UT, USA). Women will be seated in a chair with the assessed limb placed at a knee angle of 90° (with full knee extension corresponding to 180°). They will be asked to push as hard as possible for 5 seconds against the dynamometer held by a strap attached to the chair. The highest value in Newton (N) of three measurements will be recorded, and the average of both limbs results will be used for analysis.	Baseline (T0), 3 months (T3), and 6 months (T6)
Secondary	Change of quality of life in 5 dimensions	Quality of life will be assessed with the French version of the EuroQoL-5-Dimensions (EQ-5D, Jannssen et al., 2013). The EQ-5D comprises five items measuring quality of life along five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, participants have five response options ranging from "no problems" to "unable." Lower scores indicating better quality of life.	Baseline (T0), 3 months (T3), and 6 months (T6)
Secondary	Change of quality of life in visual analog scale	Quality of life will be assessed with the French version of the EuroQoL-visual analog scale (EQ-VAS, Jannssen et al., 2013). The EQ-VAS has a single item for which the women will be asked to rate their current health on a scale from 0: "worst imaginable" to 100: "best imaginable." Higher scores indicating better quality of life	Baseline (T0), 3 months (T3), and 6 months (T6)
Secondary	Change of body mass index	Height (meters) and body mass (kilograms) will be measured by medical staff and used to calculate the BMI (kg/m²).	Baseline (T0), 3 months (T3), and 6 months (T6)
Secondary	Change of body composition	Body composition will be measured by bioimpedance using the Biody XpertZM (Aminogram, France): muscle mass (kg), fat mass (kg), and bone mineral content (kg). For analyses these measures will be converted to percentages.	Baseline (T0), 3 months (T3), and 6 months (T6)