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

• ClinicalTrials.gov Identifier: NCT02694796
• Recruitment Status: Completed
• First Posted: March 1, 2016
• Last Update Posted: June 29, 2018
• Sponsor: Association Francaise pour la Recherche Thermale
• Information provided by (Responsible Party): Association Francaise pour la Recherche Thermale

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Physical Activity; Chronic Diseases; Obesity; Diabetes; Rheumatic Diseases; Cardiovascular Diseases; Breast Cancer; Chronic Obstructive Pulmonary Disease	Behavioral: Physical activity program after a balneotherapy	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 230 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• 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 Start Date: September 2015
• Actual Primary Completion Date: December 20, 2017
• Actual Study Completion Date: December 20, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: 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
No Intervention: Control; Patients included in the control arm will receive a booklet including informations about physical activity recommendations and practice.

Outcome Measures

Primary Outcome Measures :

1. Achievement of Physical activity recommendations [ Time Frame: at 12 months of follow-up ]

   Proportion of patients in each arm of the study (intervention and control) who achieve physical activity recommendations.

   Physical activity will be measured by IPAQ questionnaire (International Physical Activity Questionnaire). Achievement of physical activity recommendations corresponds to 150 minutes of moderate physical activity per week.

   To compare physical activity at 12 months, a constrained Longitudinal Data Analysis will be used involving the repeated measure of physical activity at inclusion and every 2 months until the end of the 12 months of follow-up.

Secondary Outcome Measures :

1. Physical activity [ Time Frame: at inclusion, 6 and 12 months of follow-up ]
   IPAQ questionnaire to evaluate in each arm of the study physical activity (like physical activity level, sedentary time, the proportion of patients reporting an increase of at least 20 minutes of moderate physical activity per week)
2. Weight [ Time Frame: at inclusion, 6 and 12 months of follow-up ]
3. Waist circumference [ Time Frame: at inclusion, 6 and 12 months of follow-up ]
4. Quality of life [ Time Frame: at inclusion, 6 and 12 months of follow-up ]
   The quality of life will be measured thanks to the SF-12 questionnaire (Short Form Health Survey)
5. Captured physical activity [ Time Frame: at return home after the end of the balneotherapy, at 6 months and at 12 months of follow-up ]
   Physical activity will be measured thanks to accelerometers integrated into smartphones

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 79 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Thermes CHEVALLEY

Aix-les-Bains, France, 73100

Centre thermal d'Amélie-les-Bains

Amélie-les-Bains, France, 66110

Thermes de Bourbon-Lancy

Bourbon Lancy, France, 71140

Thermes de Brides-les-Bains

Brides-les-Bains, France, 73573

Caleden Complexe Thermal

Chaudes-Aigues, France, 15110

Centre thermal d'Eugénie-les-Bains

Eugénie-les-Bains, France, 40320

Thermes du Boulou

Le Boulou, France, 66160

Thermes de Vals-les-Bains

Vals-les-Bains, France, 07600

Thermes CALLOU

Vichy, France, 03200

Sponsors and Collaborators

Association Francaise pour la Recherche Thermale

Investigators

• Principal Investigator: Martine DUCLOS, MD-PhD; Centre Hospitalier Universitaire Gabriel Montpied, Clermont Ferrand

More Information

Publications:

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.

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. Review.

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.

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). pii: e002239. doi: 10.1161/JAHA.115.002239.

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.

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.

• Responsible Party: Association Francaise pour la Recherche Thermale
• ClinicalTrials.gov Identifier: NCT02694796
• Other Study ID Numbers: C2015/02
• First Posted: March 1, 2016
• Last Update Posted: June 29, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Association Francaise pour la Recherche Thermale:

Web and smartphone-based physical activity program; Connected devices; Balneotherapy

Additional relevant MeSH terms:

Rheumatic Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases; Collagen Diseases; Chronic Disease; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Musculoskeletal Diseases; Connective Tissue Diseases