PMID- 31376274 OWN - NLM STAT- MEDLINE DCOM- 20200513 LR - 20200513 IS - 1438-8871 (Electronic) IS - 1439-4456 (Print) IS - 1438-8871 (Linking) VI - 21 IP - 8 DP - 2019 Aug 2 TI - Efficacy of a Self-Regulation-Based Electronic and Mobile Health Intervention Targeting an Active Lifestyle in Adults Having Type 2 Diabetes and in Adults Aged 50 Years or Older: Two Randomized Controlled Trials. PG - e13363 LID - 10.2196/13363 [doi] LID - e13363 AB - BACKGROUND: Adopting an active lifestyle plays a key role in the prevention and management of chronic diseases such as type 2 diabetes mellitus (T2DM). Web-based interventions are able to alter health behaviors and show stronger effects when they are informed by a behavior change theory. MyPlan 2.0 is a fully automated electronic health (eHealth) and mobile health (mHealth) intervention targeting physical activity (PA) and sedentary behavior (SB) based on the Health Action Process Approach (HAPA). OBJECTIVE: This study aimed to test the short-term effect of MyPlan 2.0 in altering levels of PA and SB and in changing personal determinants of behavior in adults with T2DM and in adults aged >/=50 years. METHODS: The study comprised two randomized controlled trials (RCTs) with an identical design. RCT 1 was conducted with adults with T2DM. RCT 2 was performed in adults aged >/=50 years. Data were collected via face-to-face assessments. The participants decided either to increase their level of PA or to decrease their level of SB. The participants were randomly allocated with a 2:1 ratio to the intervention group or the waiting-list control group. They were not blinded for their group allocation. The participants in the intervention group were instructed to go through MyPlan 2.0, comprising 5 sessions with an interval of 1 week between each session. The primary outcomes were objectively measured and self-reported PA (ie, light PA, moderate-to-vigorous PA, total PA, number of steps, and domain-specific [eg, transport-related] PA) and SB (ie, sitting time, number of breaks from sitting time, and length of sitting bouts). Secondary outcomes were self-reported behavioral determinants for PA and SB (eg, self-efficacy). Separate linear mixed models were performed to analyze the effects of MyPlan 2.0 in the two samples. RESULTS: In RCT 1 (n=54), the PA intervention group showed, in contrast to the control group, a decrease in self-reported time spent sitting (P=.09) and an increase in accelerometer-measured moderate (P=.05) and moderate-to-vigorous PA (P=.049). The SB intervention group displayed an increase in accelerometer-assessed breaks from sedentary time in comparison with the control group (P=.005). A total of 14 participants of RCT 1 dropped out. In RCT 2 (n=63), the PA intervention group showed an increase for self-reported total PA in comparison with the control group (P=.003). Furthermore, in contrast to the control group, the SB intervention group decreased their self-reported time spent sitting (P=.08) and increased their accelerometer-assessed moderate (P=.06) and moderate-to-vigorous PA (P=.07). A total of 8 participants of RCT 2 dropped out. CONCLUSIONS: For both the samples, the HAPA-based eHealth and mHealth intervention, MyPlan 2.0, was able to improve only some of the primary outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT03291171; http://clinicaltrials.gov/ct2/show/NCT03291171. ClinicalTrials.gov NCT03799146; http://clinicaltrials.gov/ct2/show/NCT03799146. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/12413. CI - (c)Louise Poppe, Ilse De Bourdeaudhuij, Maite Verloigne, Samyah Shadid, Jelle Van Cauwenberg, Sofie Compernolle, Geert Crombez. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 02.08.2019. FAU - Poppe, Louise AU - Poppe L AUID- ORCID: 0000-0001-9285-6962 AD - Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium. AD - Department of Experimental Clinical and Health Psychology, Ghent University, Ghent, Belgium. FAU - De Bourdeaudhuij, Ilse AU - De Bourdeaudhuij I AUID- ORCID: 0000-0001-9969-7597 AD - Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium. FAU - Verloigne, Maite AU - Verloigne M AUID- ORCID: 0000-0002-9048-3821 AD - Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium. FAU - Shadid, Samyah AU - Shadid S AUID- ORCID: 0000-0002-6601-0944 AD - Department of Endocrinology, Ghent University Hospital, Ghent, Belgium. FAU - Van Cauwenberg, Jelle AU - Van Cauwenberg J AUID- ORCID: 0000-0003-1292-6241 AD - Department of Public Health and Primary Care, Ghent University, Ghent, Belgium. FAU - Compernolle, Sofie AU - Compernolle S AUID- ORCID: 0000-0001-7742-2592 AD - Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium. FAU - Crombez, Geert AU - Crombez G AUID- ORCID: 0000-0002-4744-8561 AD - Department of Experimental Clinical and Health Psychology, Ghent University, Ghent, Belgium. LA - eng SI - ClinicalTrials.gov/NCT03291171 SI - ClinicalTrials.gov/NCT03799146 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20190802 PL - Canada TA - J Med Internet Res JT - Journal of medical Internet research JID - 100959882 SB - IM MH - Diabetes Mellitus, Type 2/*psychology MH - *Electronics MH - Exercise/*physiology MH - Female MH - Humans MH - Male MH - Middle Aged MH - Randomized Controlled Trials as Topic MH - Sedentary Behavior MH - Self-Control/*psychology MH - Telemedicine/*methods PMC - PMC6696857 OTO - NOTNLM OT - eHealth OT - mHealth OT - physical activity OT - self-regulation OT - type 2 diabetes COIS- Conflicts of Interest: The authors of this manuscript were involved in the development of the evaluated intervention. EDAT- 2019/08/04 06:00 MHDA- 2020/05/14 06:00 PMCR- 2019/08/02 CRDT- 2019/08/04 06:00 PHST- 2019/01/10 00:00 [received] PHST- 2019/06/19 00:00 [accepted] PHST- 2019/06/18 00:00 [revised] PHST- 2019/08/04 06:00 [entrez] PHST- 2019/08/04 06:00 [pubmed] PHST- 2020/05/14 06:00 [medline] PHST- 2019/08/02 00:00 [pmc-release] AID - v21i8e13363 [pii] AID - 10.2196/13363 [doi] PST - epublish SO - J Med Internet Res. 2019 Aug 2;21(8):e13363. doi: 10.2196/13363.