Identifying the Effect and Working Mechanisms of MyPlan 2.0 in Adults With Type 2 Diabetes

NCT03291171 | Completed

• 1 other identifier: MyPlan2.0_diabetes
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate whether and how 'MyPlan 2.0' helps adults with type 2 diabetes to be more physically active or less sedentary. Two groups will be created, an intervention group and a waiting-list control group.

Conditions

Chronic Disease

Keywords

physical activity; sedentary behaviour; type 2 diabetes; eHealth; mHealth; self-regulation; behaviour change techniques

Outcome Measures

Primary Outcomes (4)

• Change in objective total, light and moderate-to-vigorous physical activity (PA)

  Change in amount of total, light and moderate-to-vigorous physical activity, measured via accelerometers

  Pretest, posttest (6 weeks) and follow-up (6 months)

• Change in objective sedentary behaviour

  Change in amount of total sitting time, measured via accelerometers

  Pretest, posttest (6 weeks) and follow-up (6 months)

• Change in self-reported total, light and moderate-to-vigorous physical activity (PA)

  Change in amount of total, light and moderate-to-vigorous physical activity, measured via the International Physical Activity Questionnaire (IPAQ)

  Pretest, posttest (6 weeks) and follow-up (6 months)

• Change in self-reported sedentary behaviour

  Change in amount of total sitting time, measured via the LASA sedentary behaviour self-report questionnaire

  Pretest, posttest (6 weeks) and follow-up (6 months)

Secondary Outcomes (6)

• Change in self-efficacy

  Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)

• Change in outcome expectancies

  Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)

• Change in risk perception

  Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)

• Change in intention

  Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)

• change in action planning

  Pretest, after week 1, after week 2, after week 3, after week 4, posttest (6 weeks), and follow-up (6 months)

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will receive the e- and mHealth intervention 'MyPlan 2.0'.

Behavioral: MyPlan 2.0

Waiting-list control group

NO INTERVENTION

Participants will not receive the e- and mHealth intervention 'MyPlan 2.0', but will be given access to the intervention after all testing phases.

Interventions

MyPlan 2.0 BEHAVIORAL

MyPlan 2.0 consists of five sessions. During these five sessions the following behaviour change techniques are used to motivate users to be more physically active or to sit less: exploring risk perceptions and perceived benefits, exploring social support, providing feedback, action planning, coping planning and monitoring.

Intervention group

Eligibility Criteria

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

You may qualify if:

• years or older
• Type 2 diabetes
• Have access to internet
• Being computer literate

You may not qualify if:

• not Dutch Speaking

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Department of Movement and Sports Sciences

Ghent, 9000, Belgium

Location

Related Publications (1)

• Poppe L, De Bourdeaudhuij I, Verloigne M, Shadid S, Van Cauwenberg J, Compernolle S, Crombez G. 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. J Med Internet Res. 2019 Aug 2;21(8):e13363. doi: 10.2196/13363.

  PMID: 31376274 DERIVED

MeSH Terms

Conditions

Chronic Disease; Motor Activity; Diabetes Mellitus, Type 2; Self-Control

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Social Behavior

Study Officials

• Ilse De Bourdeaudhuij, Professor

  University Ghent

  PRINCIPAL INVESTIGATOR

• Geert Crombez, Professor

  University Ghent

  PRINCIPAL INVESTIGATOR

• Maïté Verloigne, PostDoc

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with two groups: intervention group and waiting-list control group

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 25, 2017
• Study Start: October 15, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: December 6, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)