Pilot randomised controlled trial to assess the use of food diaries and pedometers on the glycaemic control and weight in people with type 2 diabetes requiring insulin that are obese
| ISRCTN | ISRCTN58771838 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58771838 |
| Protocol serial number | N/A |
| Sponsor | University of York (UK) |
| Funder | Investigator initiated and funded (UK) |
- Submission date
- 17/09/2007
- Registration date
- 10/07/2008
- Last edited
- 13/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Paul Thomas
Scientific
Scientific
Department of Dietetics & Nutrition
Barnsley Hospital NHS Foundation Trust
Gawber Road
Barnsley
S75 2EP
United Kingdom
| Phone | +44 (0)1226 432606 |
|---|---|
| paulthomas@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot, randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Barnsley Research Ethics Committee. Date of approval: 06/12/2006 (ref: 06/Q2304/44) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Recruitment and retention rates |
| Key secondary outcome measure(s) |
The following were assessed at baseline and week 14: |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 32 |
| Key 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) |
| Key exclusion criteria | 1. Hypothyroid 2. Anyone using anti-obesity medication |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Dietetics & Nutrition
Barnsley
S75 2EP
United Kingdom
S75 2EP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
