Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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13 January 2015 |
Main ID: |
ISRCTN05815264 |
Date of registration:
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09/08/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The effect of self-weighing as a weight loss intervention
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Scientific title:
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The efficacy of self-weighing as a weight loss intervention: randomised controlled trial |
Date of first enrolment:
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01/08/2012 |
Target sample size:
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216 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN05815264 |
Study type:
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Interventional |
Study design:
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Two arm pragmatic randomised controlled trial (individual randomisation) with participants allocated to daily self-weighing or comparator group. (Screening)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Claire
Madigan |
Address:
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The University of Birmingham
Primary Care Clinical Sciences
Edgbaston
B15 2TT
Birmingham
United Kingdom |
Telephone:
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+44 (0)121 414 8067 |
Email:
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cdm153@bham.ac.uk |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patients must be aged >18 years 2. Have a raised BMI of >30 kg/m2 3. Considered suitable to participate by their GP
Exclusion criteria: 1. Pregnant or intending to fall pregnant within the study time period 2. Cannot understand or speak English sufficiently to undertake the tasks of the study 3. Currently attending a weight management programme (including pharmacotherapy or bariatric surgery) or has taken part in a formal weight management programme in the previous three months 4. Currently weigh them self at least once per week
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Weight management Nutritional, Metabolic, Endocrine Obesity
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Intervention(s)
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At baseline (visit 1), participants will receive a brief consultation to discuss weight management tips; which would be similar to a consultation that a GP or practice nurse might offer. Participants will also receive a booklet detailing weight management tips adapted from the Department of Health publication, Your Weight, Your Health. We will ask participants to complete a four day food diary and this will be discussed with the researcher one week later (i.e. at visit 2). There are two reasons for doing this. We want to make sure participants are weighing themselves daily and that they can identify potential changes that could be made to their diet.
Participants will also receive a leaflet, and have a discussion about the potential benefits of daily self-weighing within the consultation. Participants will be given a set of weighing scales and instructed to weigh themselves daily and record their weight on the report card provided. As this is an efficacy trial it is important to ensure participants weigh themselves daily and therefore brief weekly text message reminders will be sent to participants. At visit 2 the frequency of participants self-weighing over the previous week will be discussed. Those not weighing themselves daily will be further encouraged to do so and given ideas/strategies of how they might implement (frequent) self weighing into their everyday lives (e.g. using social support and cues to action). The benefits of self-weighing will be reiterated. Participants will be advised they should aim to lose 0.5 kg of body weight per week.
The comparator group will receive the same consultations as the intervention group as described above but there will be no mention or encouragement of daily self-weighing.
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Primary Outcome(s)
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Weight change between baseline and three months
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Secondary Outcome(s)
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1. The difference in weight change from baseline to 12 months between the groups (subject to the results at 3 months) 2. The difference in physical activity, quality of life, and weight management strategies between the groups
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Secondary ID(s)
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12/WM/0137
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Source(s) of Monetary Support
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National Institute for Health Research
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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