NCT01301196

Brief Summary

Excessive periods of time spent sitting may be a risk factor for diabetes. Current lifestyles encourage large amounts of sitting (sedentary behaviour) through increasing car use, computers, and appealing screen-based home entertainment systems. Methods to help change such behaviours are now needed, particularly for those with a high risk of developing a chronic disease, such as diabetes. The investigators propose to decrease sedentary behaviour in a multi-ethnic group of young adults at risk of diabetes through an educational intervention (attending a workshop and having prompts). If successful, this could have significant public health benefits given the widespread nature of sedentary behaviour.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
189

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 23, 2011

Status Verified

October 1, 2010

Enrollment Period

1.4 years

First QC Date

February 22, 2011

Last Update Submit

February 22, 2011

Conditions

Type 2 Diabetes Mellitus

Keywords

sedentary behaviourdiabetesstructured education18-30 years oldsfamily history of T2DM or CVDBMI ≥ 25 (≥23 for south Asians)

Outcome Measures

Primary Outcomes (1)

  • Sedentary behaviour

    Sedentary behaviour (time \< 100 counts/min as assessed by 1-week accelerometry, using the new Actigraph GT3X) at 12 months

    12 months

Secondary Outcomes (5)

  • Biomarkers

    12 months

  • Screen time

    12 months

  • Self-reported behaviour

    12 months

  • Biological measures

    12 months

  • Psychosocial indicators

    12 months

Study Arms (1)

Behaviour change

EXPERIMENTAL

Attendance at 3-h workshop

Behavioral: Educational workshop

Interventions

Educational workshopBEHAVIORAL

3h attendance at educational workshop plus self-monitoring

Behaviour change

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged 18-30 years old
  • family history of T2DM or CVD (first degree relative)
  • BMI ≥ 25 (≥ 23 for south Asians)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Leicester

Leicester, Leics, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusCardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 23, 2011

Study Start

October 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

February 23, 2011

Record last verified: 2010-10

Locations

GB(1)