Clinical trial NCT02694796: Impact of Web and Smartphone-based Physical Activity Program on Physical Activity Level 12 Months After a Balneotherapy
Official title: Long Term Impact of a Physical Activity Intervention Combining Workshop During a Balneotherapy and a Web and Smartphone-based Physical Activity Program After Balneotherapy, on Physical Activity Level : a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Chronic Diseases
Obesity
Diabetes
Rheumatic Diseases
Cardiovascular Diseases
Breast Cancer
Chronic Obstructive Pulmonary Disease
Keywords: Web and smartphone-based physical activity program
Connected devices
Balneotherapy
Lead sponsor: Association Francaise pour la Recherche Thermale
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 230
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Achievement of Physical activity recommendations
timeFrame: at 12 months of follow-up
Secondary outcomes:
measure: Physical activity
timeFrame: at inclusion, 6 and 12 months of follow-up
measure: Weight
timeFrame: at inclusion, 6 and 12 months of follow-up
measure: Waist circumference
timeFrame: at inclusion, 6 and 12 months of follow-up
measure: Quality of life
timeFrame: at inclusion, 6 and 12 months of follow-up
measure: Captured physical activity
timeFrame: at return home after the end of the balneotherapy, at 6 months and at 12 months of follow-up
Other outcomes:
Locations:
city: Aix-les-Bains
country: France
facility: Thermes CHEVALLEY
city: Amélie-les-Bains
country: France
facility: Centre thermal d'Amélie-les-Bains
city: Bourbon Lancy
country: France
facility: Thermes de Bourbon-Lancy
city: Brides-les-Bains
country: France
facility: Thermes de Brides-les-Bains
city: Chaudes-Aigues
country: France
facility: Caleden Complexe Thermal
city: Eugénie-les-Bains
country: France
facility: Centre thermal d'Eugénie-les-Bains
city: Le Boulou
country: France
facility: Thermes du Boulou
city: Vals-les-Bains
country: France
facility: Thermes de Vals-les-Bains
city: Vichy
country: France
facility: Thermes CALLOU
Study officials:
affiliation: Centre Hospitalier Universitaire Gabriel Montpied, Clermont Ferrand
name: Martine DUCLOS, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.