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

November 25, 2020 updated by: Pr Fabienne d'Arripe-Longueville

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Nice, France, 06200
        • Recruiting
        • Centre Spécialisé Obésité

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: CONTROL
The Control group will receive the usual care. In the physical activity (PA) field, this includes two individual motivational interviews with a PA professional, and a group workshop during the first year after BS. PA recommendations will be explained to each participant, and their achievement will be encouraged and supported during these sessions. No face-to-face PA sessions will be offered as part of the usual care.
Experimental: ACTI-VISIO
The two PA sessions per week will be delivered via videoconferencing (developed by Mooven™). The PA program consists in tailored adapted PA sessions led by a professional specialized in adapted PA. These sessions were specifically designed to be appropriate for the population and were developed in collaboration with the authors to ensure standardization of the recommended volume of PA. The PA sessions will be given live, individually at the beginning and then in groups of four women. During sessions, the professional and the participants will interact simultaneously, and the execution of the exercises will be monitored and adapted live by the professional. To ensure the safety of the PA, a rating of perceived exertion will be requested after each session on a 10-point scale. If the RPE exceed 7, the professional specialized in adapted PA will adjust the training load. In addition to the exercises, the sessions will also include advice and tips for reaching the recommended PA level.
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.
Experimental: ACTI-MOBIL
The PA sessions will be delivered by an eHealth platform (developed by BePatient™) associated with an activity bracelet. The researchers enrich PA content on the platform and ensure standardization of the recommended volume of PA. The platform consists of tips for reaching the PA level, PA questionnaires, PA feedback measured by the activity bracelet, and a video demonstration of PA sessions performed by a peer. The PA sessions are automatically broadcasted twice a week for 12 weeks. To ensure the safety of the PA, the sessions were designed to be appropriate for this population and the RPE will be measured after each session on a 10-point scale. If the RPE exceeds 7 for 3 consecutive sessions, the training load will be adjusted. The platform will also include a variety of content, including dietary tips, obesity-related facts, information about surgery, and frequently asked questions.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of functional capacity calculated by the percentage achievement of the theoretical distance calculated by the Capodaglio's (2013) formula
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)

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)
Change of distance traveled during a six-minute walk test (6MWT)
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)
Distance traveled during a six-minute walk test (6MWT) will be expressed in meters
Baseline (T0), 3 months (T3), and 6 months (T6)
Change of body mass
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)
Kilograms
Baseline (T0), 3 months (T3), and 6 months (T6)
Height
Time Frame: Baseline (T0)
Meters
Baseline (T0)
Date of birth
Time Frame: Baseline (T0)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of subjective physical activity level
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)
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)
Change of objective physical activity level
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)
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)
Change of stage of change for physical activity
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)
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)
Change of energetic consumption measured during the 6MWT
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)
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)
Change of muscle strength
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)
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)
Change of quality of life in 5 dimensions
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)
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)
Change of quality of life in visual analog scale
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)
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)
Change of body mass index
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)
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)
Change of body composition
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)
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)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of technology acceptability
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)
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)
Program compliance
Time Frame: 3 months (T3)
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)
Change of motivation for physical activity
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)
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)
Change of general causality orientations scale for physical activity
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)
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)
Change of basic psychological needs
Time Frame: Baseline (T0), 3 months (T3), and 6 months (T6)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pr Fabienne d'Arripe-Longueville

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre Hospitalier Universitaire de Nice
Association Azur Sport Santé, Nice, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Fabienne d'Arripe-Longueville, Pr, Université Côte d'Azur, Nice, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IDRCB: 2020.A00172-37
  • ANR-15-IDEX-01 (Other Grant/Funding Number: Agence Nationale de la Recherche)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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