Condition category
Nutritional, Metabolic, Endocrine
Date applied
17/09/2007
Date assigned
10/07/2008
Last edited
13/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Paul Thomas

ORCID ID

Contact details

Department of Dietetics & Nutrition
Barnsley Hospital NHS Foundation Trust
Gawber Road
Barnsley
S75 2EP
United Kingdom
+44 (0)1226 432606
paulthomas@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Using food diaries and pedometers as tools for empowering people to make lifestyle changes that will encourage a reduction in their weight and improve their glycaemic control.

Ethics approval

Barnsley Research Ethics Committee. Date of approval: 06/12/2006 (ref: 06/Q2304/44)

Study design

Pilot, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Diabetes mellitus - type 2

Intervention

Intervention schedule:
Week 1: All participants kept a food and pedometer diary
Week 2 to 13: Participants were in randomised groups (see below for details)
Week 14: All participants kept a food and pedometer diary

Participants were randomly assigned to the following four groups:
Group 1: Pedometer. Participants were asked to use a pedometer and record the daily number of steps, and at the end of the week, to review what they had completed, and maybe to try to increase it
Group 2: Food Diary. Participants were asked to complete a food diary on a daily basis, and at the end of the week, to review it and see if they could make dietary changes
Group 3: Food Diary and pedometer. Participants were asked to complete a food and pedometer diary on a daily basis, and at the end of the week, to review it and see if they could make changes
Group 4: Control. Participants did not keep a food diary or pedometer diary

A dietitian undertaking the research instructed the participants on the use of food diaries and pedometers. Participants met the trial staff at the initial meeting and then every 4 weeks.

Total duration of follow-up: 14 weeks

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Recruitment and retention rates

Secondary outcome measures

The following were assessed at baseline and week 14:
1. HbA1c
2. Serum lipids
3. Blood pressure
4. Weight
5. BMI
6. Waist circumference
7. Percentage body fat

Overall trial start date

01/01/2007

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both male and female patients, no age limits
1. Diabetes mellitus - type 2
2. Requiring insulin treatment
3. Obese (Body Mass Index [BMI] greater than 30)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32

Participant exclusion criteria

1. Hypothyroid
2. Anyone using anti-obesity medication

Recruitment start date

01/01/2007

Recruitment end date

01/07/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Dietetics & Nutrition
Barnsley
S75 2EP
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

York Trials Unit
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321340
djt6@york.ac.uk

Sponsor type

University/education

Website

http://www.york.ac.uk

Funders

Funder type

Other

Funder name

Investigator initiated and funded (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

No publication intended as of 13/10/2011

Publication citations

Additional files

Editorial Notes