Impact of Web and Smartphone-based Physical Activity Program on Physical Activity Level 12 Months After a Balneotherapy

NCT ID: NCT02694796

Last Updated: 2018-06-29

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-12-20

Brief Summary

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The purpose of this study is to evaluate the impact of an intervention combining a workshop during a balneotherapy and the use after the end of the balneotherapy of a web and smartphone-based physical activity program using connected devices, on physical activity level among patients 12 months after they participated in a balneotherapy in thermal care center.

A multi center randomized controlled trial is setting to evaluate the impact of the intervention on physical activity recommendations achievement of the patients.

Investigators hypothesize that an intervention including a workshop during a balneotherapy and an automated physical activity program using web, mobile phone and connected devices will help patients to be engaged in more physical activities and to reach physical activity recommendations.

Detailed Description

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New technologies such as mobile phone and connected devices have been recognized as useful tools to assist chronic patients in their disease's management. they are also considering as promising tools to help patients to change their lifestyle behavior.

Balneotherapy is a very special moment to initiate changes and to raise awareness about healthier behavior in terms of food and physical activity.

The objective of the intervention is to help patients with chronic diseases, taking part in a balneotherapy, to increase or maintain their physical activity level in the long term to reach the national recommendations of 150 minutes of moderate physical activity per week.

Patients will be randomized either in the intervention group or in the control group.

The intervention group will participate in a workshop during the balneotherapy providing them informations about physical activity and also about the way to use the web and smartphone-based physical activity program along with the use of the connected devices (scale and pedometer). After the end of the balneotherapy, the intervention group will have access to the web and smartphone-based physical activity program during 12 months.

The control group will receive a booklet including informations about physical activity practice.

Conditions

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Physical Activity Chronic Diseases Obesity Diabetes Rheumatic Diseases Cardiovascular Diseases Breast Cancer Chronic Obstructive Pulmonary Disease

Keywords

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Web and smartphone-based physical activity program Connected devices Balneotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

The 'Physical activity program after a balneotherapy' intervention involves providing a workshop during a balneotherapy about physical activity and use of automated physical activity program including website, mobile app and connected devices, and after the balneotherapy, the access to the automated program during 12 months.

Group Type EXPERIMENTAL

Physical activity program after a balneotherapy

Intervention Type BEHAVIORAL

workshop during the balneotherapy associated to an automated program of physical activity after the end of the balneotherapy available during 12 months

Control

Patients included in the control arm will receive a booklet including informations about physical activity recommendations and practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical activity program after a balneotherapy

workshop during the balneotherapy associated to an automated program of physical activity after the end of the balneotherapy available during 12 months

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age between 50 and 79
* BMI between 19 and 35 kg.m2
* stabilized chronic disease : cardiovascular disease, obesity, diabetes, chronic obstructive pulmonary disease, rheumatic diseases, breast cancer
* practice of moderate physical activity less than 150 minutes per week
* practice of sportive activity less than 2h per week
* having access to internet
* possessing a smartphone connected to internet
* good comprehension of french
* notice and informed consent signed
* no contraindication to practice physical activity
* subject to French Social Security

Exclusion Criteria

* wearing a cardiac pacemaker
* non-stabilized chronic disease
* invalidating pathology of locomotor system
* metastatic cancers
* being in an exclusion period for participating in another study or having received more than 4500€ during the year due to participation in clinical studies
* being under supervision
* refusing to be register in the French National Volunteers Register
Minimum Eligible Age

50 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association Francaise pour la Recherche Thermale

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martine DUCLOS, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Gabriel Montpied, Clermont Ferrand

Locations

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Thermes CHEVALLEY

Aix-les-Bains, , France

Site Status

Centre thermal d'Amélie-les-Bains

Amélie-les-Bains, , France

Site Status

Thermes de Bourbon-Lancy

Bourbon-Lancy, , France

Site Status

Thermes de Brides-les-Bains

Brides-les-Bains, , France

Site Status

Caleden Complexe Thermal

Chaudes-Aigues, , France

Site Status

Centre thermal d'Eugénie-les-Bains

Eugénie-les-Bains, , France

Site Status

Thermes du Boulou

Le Boulou, , France

Site Status

Thermes de Vals-les-Bains

Vals-les-Bains, , France

Site Status

Thermes CALLOU

Vichy, , France

Site Status

Countries

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France

References

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van der Weegen S, Verwey R, Spreeuwenberg M, Tange H, van der Weijden T, de Witte L. It's LiFe! Mobile and Web-Based Monitoring and Feedback Tool Embedded in Primary Care Increases Physical Activity: A Cluster Randomized Controlled Trial. J Med Internet Res. 2015 Jul 24;17(7):e184. doi: 10.2196/jmir.4579.

Reference Type BACKGROUND
PMID: 26209025 (View on PubMed)

Aalbers T, Baars MA, Rikkert MG. Characteristics of effective Internet-mediated interventions to change lifestyle in people aged 50 and older: a systematic review. Ageing Res Rev. 2011 Sep;10(4):487-97. doi: 10.1016/j.arr.2011.05.001. Epub 2011 May 20.

Reference Type BACKGROUND
PMID: 21628005 (View on PubMed)

Ammann R, Vandelanotte C, de Vries H, Mummery WK. Can a website-delivered computer-tailored physical activity intervention be acceptable, usable, and effective for older people? Health Educ Behav. 2013 Apr;40(2):160-70. doi: 10.1177/1090198112461791. Epub 2012 Oct 16.

Reference Type BACKGROUND
PMID: 23077157 (View on PubMed)

Martin SS, Feldman DI, Blumenthal RS, Jones SR, Post WS, McKibben RA, Michos ED, Ndumele CE, Ratchford EV, Coresh J, Blaha MJ. mActive: A Randomized Clinical Trial of an Automated mHealth Intervention for Physical Activity Promotion. J Am Heart Assoc. 2015 Nov 9;4(11):e002239. doi: 10.1161/JAHA.115.002239.

Reference Type BACKGROUND
PMID: 26553211 (View on PubMed)

Krebs P, Prochaska JO, Rossi JS. A meta-analysis of computer-tailored interventions for health behavior change. Prev Med. 2010 Sep-Oct;51(3-4):214-21. doi: 10.1016/j.ypmed.2010.06.004. Epub 2010 Jun 15.

Reference Type BACKGROUND
PMID: 20558196 (View on PubMed)

Irvine AB, Gelatt VA, Seeley JR, Macfarlane P, Gau JM. Web-based intervention to promote physical activity by sedentary older adults: randomized controlled trial. J Med Internet Res. 2013 Feb 5;15(2):e19. doi: 10.2196/jmir.2158.

Reference Type BACKGROUND
PMID: 23470322 (View on PubMed)

Fillol F, Paris L, Pascal S, Mulliez A, Roques CF, Rousset S, Duclos M. Possible Impact of a 12-Month Web- and Smartphone-Based Program to Improve Long-term Physical Activity in Patients Attending Spa Therapy: Randomized Controlled Trial. J Med Internet Res. 2022 Jun 16;24(6):e29640. doi: 10.2196/29640.

Reference Type DERIVED
PMID: 35708743 (View on PubMed)

Other Identifiers

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C2015/02

Identifier Type: -

Identifier Source: org_study_id