NCT02211040

Brief Summary

The investigators have developed an eHealth intervention based on self-regulation for the promotion of self-regulation of physical activity and fruit and vegetable intake among adults who visit general practice. Effectiveness of the intervention will be evaluated in a three-arm clustered quasi-experimental design in general practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
426

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

July 18, 2014

Last Update Submit

May 4, 2017

Conditions

Physical ActivityFruit and Vegetable IntakeSelf-regulationEmpowerment

Keywords

Intervention Mapping Protocolphysical activityfruit intakevegetable intakecomputer tailoringeHealthself-regulationgoal settingproblem solvinggeneral practice

Outcome Measures

Primary Outcomes (2)

  • "Change from Baseline in physical activity level at 1 and 6 months"

    Amount of physical activity per day and per week

    After 1 and 6 months

  • "Change from Baseline in fruit and vegetable intake at 1 and 6 months"

    After 1 and 6 months

Secondary Outcomes (1)

  • "Change from Baseline in scores on self-regulation skills at 1 and 6 months"

    After 1 and 6 months

Study Arms (2)

No general practitioner involvement

EXPERIMENTAL

The selection and motivation of adults will be conducted by a researcher in the waiting room. There is no extra motivation of the general practitioner.

Behavioral: My Plan

General practitioner involvement

EXPERIMENTAL

An intervention group in which general practitioners select and motivate adults to be more physical active and eat more fruit and vegetables.

Behavioral: My Plan

Interventions

My PlanBEHAVIORAL

The intervention consists of three sessions for each behaviour (ie., physical activity, fruit and vegetables intake) and is available on a website and tablets to deliver it in general practice. Adults can start session one on a tablet in general practice or on their own computer at home, after receiving a flyer in general practice. In this first session adults receive general information, monitor their behaviour and receive tailored feedback to increase awareness. Adults are also guided to set goals and self-efficacy is increased by modeling and problem solving methods. In the second and third session, adults can evaluate if they reached their goals, make coping plans and adapt their action plans.

General practitioner involvementNo general practitioner involvement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 years
  • Having access to internet

You may not qualify if:

  • No access to internet
  • Younger than 18 years
  • Not understanding the Dutch Language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jolien Plaete

Ghent, East Flanders, 9000, Belgium

Location

Related Publications (2)

  • Van Dyck D, Plaete J, Cardon G, Crombez G, De Bourdeaudhuij I. Effectiveness of the self-regulation eHealth intervention 'MyPlan1.0.' on physical activity levels of recently retired Belgian adults: a randomized controlled trial. Health Educ Res. 2016 Oct;31(5):653-64. doi: 10.1093/her/cyw036. Epub 2016 Jul 15.

    PMID: 27422898DERIVED

  • Plaete J, Crombez G, Van der Mispel C, Verloigne M, Van Stappen V, De Bourdeaudhuij I. Effect of the Web-Based Intervention MyPlan 1.0 on Self-Reported Fruit and Vegetable Intake in Adults Who Visit General Practice: A Quasi-Experimental Trial. J Med Internet Res. 2016 Feb 29;18(2):e47. doi: 10.2196/jmir.5252.

    PMID: 26929095DERIVED

Related Links

MeSH Terms

Conditions

Motor ActivitySelf-ControlEmpowerment

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor doctor Ilse De Bourdeaudhuij

Study Record Dates

First Submitted

July 18, 2014

First Posted

August 7, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2015

Study Completion

July 1, 2015

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations

BE(1)