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

NCT02694796 | Completed DMC

• 1 other identifier: C2015/02
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 9

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.

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

Outcome Measures

Primary Outcomes (1)

• Achievement of Physical activity recommendations

  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.

  at 12 months of follow-up

Secondary Outcomes (5)

• Physical activity

  at inclusion, 6 and 12 months of follow-up

• Weight

  at inclusion, 6 and 12 months of follow-up

• Waist circumference

  at inclusion, 6 and 12 months of follow-up

• Quality of life

  at inclusion, 6 and 12 months of follow-up

• Captured physical activity

  at return home after the end of the balneotherapy, at 6 months and at 12 months of follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Physical activity program after a balneotherapy BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• wearing a cardiac pacemaker
• non-stabilized chronic disease
• invalidating pathology of locomotor system
• metastatic cancers
• being under supervision
• refusing to be register in the French National Volunteers Register

Sponsors & Collaborators

• Association Francaise pour la Recherche Thermale: lead

Study Sites (9)

Thermes CHEVALLEY

Aix-les-Bains, 73100, France

Location

Centre thermal d'Amélie-les-Bains

Amélie-les-Bains, 66110, France

Location

Thermes de Bourbon-Lancy

Bourbon-Lancy, 71140, France

Location

Thermes de Brides-les-Bains

Brides-les-Bains, 73573, France

Location

Caleden Complexe Thermal

Chaudes-Aigues, 15110, France

Location

Centre thermal d'Eugénie-les-Bains

Eugénie-les-Bains, 40320, France

Location

Thermes du Boulou

Le Boulou, 66160, France

Location

Thermes de Vals-les-Bains

Vals-les-Bains, 07600, France

Location

Thermes CALLOU

Vichy, 03200, France

Location

Related Publications (7)

• 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.

  PMID: 26209025 BACKGROUND

• 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.

  PMID: 21628005 BACKGROUND

• 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.

  PMID: 23077157 BACKGROUND

• 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.

  PMID: 26553211 BACKGROUND

• 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.

  PMID: 20558196 BACKGROUND

• 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.

  PMID: 23470322 BACKGROUND

• 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.

  PMID: 35708743 DERIVED

MeSH Terms

Conditions

Motor Activity; Chronic Disease; Obesity; Diabetes Mellitus; Rheumatic Diseases; Cardiovascular Diseases; Breast Neoplasms; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Martine DUCLOS, MD-PhD

  Centre Hospitalier Universitaire Gabriel Montpied, Clermont Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: March 1, 2016
• Study Start: September 1, 2015
• Primary Completion: December 20, 2017
• Study Completion: December 20, 2017
• Last Updated: June 29, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)