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ISRCTN
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ISRCTN35774128
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ClinicalTrials.gov identifier
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Public title
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Weight Loss Maintenance in Adults
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Scientific title
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A randomised controlled trial of a 12-month multi-component intervention versus a less intensive version on study participants' maintenance of weight loss
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Acronym
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WILMA
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Serial number at source
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HTA 08/44/04
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Study hypothesis
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Does a 12-month multi-component intervention or a less intensive version of it enable study participants' to maintain weight lost (prior to study entry) three years from randomisation?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Three-arm individually randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Obesity/public health/behaviour change
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Participants - inclusion criteria
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1. Obese adults aged 18 - 70 years, either sex
2. Current or previous body mass index (BMI) of 30 or above
3. Lost at least 5% body weight (by pharmacological, lifestyle and/or behavioural methods) during the last 12 months
4. Independent verification of weight loss
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Participants - exclusion criteria
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1. Unable to comply with study protocol, e.g., due to mental health problems, terminal illness or competence in English
2. Pregnant women
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Anticipated start date
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01/04/2010
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Anticipated end date
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31/03/2015
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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950
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Interventions
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1. Intense intervention - six one-to-one motivational interviewing (MI) sessions plus four group sessions and 11 brief MI phone calls
2. Less intense intervention - two one-to-one MI sessions plus four group sessions and two brief MI phone calls
The total duration of treatrment is 12 months in both intervention arms and the total duration of follow up is 3 years from randomisation for all study participants.
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Primary outcome measure(s)
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BMI at 3 years from randomisation
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Secondary outcome measure(s)
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1. Waist circumference, measured at baseline, post intervention, 12 months and 24 months after the end of the intervention
2. Waist to hip ratio, measured at baseline, post intervention, 12 months and 24 months after the end of the intervention
3. Body fat distribution, measured at baseline, post intervention, 12 months and 24 months after the end of the intervention
4. Self report physical activity, collected at baseline, 6 months (during intervention), post-intervention, 12 month follow-up after end of intervention and 24 months after the end of the intervention
5. Proportion maintaining weight loss, measured post-intervention and at 12 and 24 months after intervention
6. Self report dietary intake, collected at baseline, 6 months (during intervention), post-intervention, 12 month follow-up after end of intervention and 24 months after the end of the intervention
7. Health related quality of life, collected at baseline, 6 months (during intervention), post-intervention, 12 month follow-up after end of intervention and 24 months after the end of the intervention
8. Health resource usage, collected at baseline, 6 months (during intervention), post-intervention, 12 month follow-up after end of intervention and 24 months after the end of the intervention
9. Binge eating, measured post-intervention and at 12 and 24 months after intervention
10. Psychological well being and duration of participation and drop out from intervention, measured post-intervention and at 12 and 24 months after intervention
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://www.cf.ac.uk/medic/subsites/sewtu/
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Publications
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Contact name
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Dr
Sharon
Simpson
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Address
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Department of Primary Care and Public Health
Cardiff University School of Medicine
7th floor Neuadd Meirionnydd
Heath Park
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City/town
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Cardiff
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Zip/Postcode
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CF14 4YS
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Country
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United Kingdom
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Tel
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+44 (0)29 2068 7181
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Email
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SimpsonSA@cf.ac.uk
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Sponsor
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Cardiff University (UK)
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Address
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Research and Commercial Division
7th Floor, 30 - 36 Newport Road
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City/town
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Cardiff
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Zip/Postcode
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CF24 0DE
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Country
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United Kingdom
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Email
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davieskp2@cardiff.ac.uk
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Sponsor website:
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http://www.cardiff.ac.uk/
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Date applied
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11/01/2010
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Last edited
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12/01/2010
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Date ISRCTN assigned
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12/01/2010
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