OverweightSWSSNCT02012426
The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight
A study testing Weight management program in people with Overweight and Obesity, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The aim of the current study is to demonstrate that a commercial weight management diet (i.e. low energy density) influences satiation, hunger and satiety and leads to lower energy intake during ad-libitum meals and over a full day. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Sedentary Lifestlye
- What is being tested?
- Weight management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI of 28 - 45 kg/m2
- Reporting an interest in weight loss, not actively participating in a commercial weight loss program,
- Not increased physical activity levels in the past 2-4 weeks
- Able to eat most everyday foods and fruits and vegetables
- Written informed consent to be given
Who cannot join
- Significant health problems that could cause confounding effects between intervention and control.
- Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study
- Pregnant, planning to become pregnant or breastfeeding
- History of anaphylaxis to food
- Known food allergies or food intolerance
- Smokers and those who have recently ceased smoking
Show all 15Show fewer
- Participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters
- Those who have previously taken part in a commercial weight loss program in the last 6 months? .
- Participants who work in appetite or feeding related areas
- Participants unable to consume foods used in the study
- Participants who have had bariatric surgery
- Participants with a history of eating disorder
- Presence of untreated hypothyroidism
- Inability to fully comply with intervention or study procedures
- Insufficient English language skills to complete study questionnaires
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leeds
Leeds, West Yorkshire, LS2 9JT
About this study
The aim of the current study is to demonstrate that a commercial weight management diet (i.e. low energy density) influences satiation, hunger and satiety and leads to lower energy intake during ad-libitum meals and over a full day. We further seek to demonstrate the sustainability of this effect following 12- week weight loss on the weight management program.
- We hypothesise that formulated (low energy) meals will lead to decreased hunger, greater fullness and reduced desire to eat compared to standard meals.
- We hypothesise that the commercial weight management program will lead to greater weight loss compared to control program.
- We hypothesise that formulated meals (high consumer acceptance) will improve hedonic control over eating (lower wanting for high fat food)
- We hypothesise that the commercial weight management program will improve hedonic control over eating (reduced experience food cravings)
- Conditions
- Overweight, Obesity, Sedentary Lifestlye
- Being tested
- Weight management program
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight management programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants enrolled in commercial weight management program Receives: Behavioral: Weight management program |
| Control group | Active comparator | Participants enrolled in standard care weight management provision Receives: Behavioral: Weight management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Meal Energy Intake
Measured reductions in ad-libitum energy intake following consumption of formulated test meal in comparison to control.
Measured: Week 0 and week 12
24h Energy Intake
Measured reduction in total within-day energy intake following consumption of formulated meals in comparison to control
Measured: Week 0 and week 12
Appetite sensations
Measured reduction in hunger and increase in satiety quotient following consumption of formulated test meal in comparison to equi-energetic control
Measured: Week 0 and week 14
Food preference
Measured changes in food preference and liking and wanting profiles for food (HF<LF) following consumption of formulated test meal in comparison to equi-energetic control
Measured: Week 0 and week 14
Secondary outcomes (1)
Body Weight
Measured change in weight and energy balance parameters over a 12 week period following participation in commercial weight management program compared to control group.
Measured: Weekly from week 0 to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Graham Finlayson, University of Leeds
- Investigators
- Graham S Finlayson, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012426
- Sponsor's protocol ID
- LDS-2013-SLW
- Other IDs
- KRISTAL No.
- Acronym
- SWSS
- Status last verified
- May 2017
- First submitted
- 10 Dec 2013
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Buckland NJ, Camidge D, Croden F, Myers A, Lavin JH, Stubbs RJ, Blundell JE, Finlayson G. Women with a low-satiety phenotype show impaired appetite control and greater resistance to weight loss. Br J Nutr. 2019 Oct 28;122(8):951-959. doi: 10.1017/S000711451900179X.
PubMed 31340872Buckland NJ, Camidge D, Croden F, Lavin JH, Stubbs RJ, Hetherington MM, Blundell JE, Finlayson G. A Low Energy-Dense Diet in the Context of a Weight-Management Program Affects Appetite Control in Overweight and Obese Women. J Nutr. 2018 May 1;148(5):798-806. doi: 10.1093/jn/nxy041.
PubMed 30053284
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight
- ClinicalTrials.gov ID
- NCT02012426
- Acronym / sponsor ID
- SWSS / LDS-2013-SLW
- Conditions
- Overweight, Obesity, Sedentary Lifestlye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the current study is to demonstrate that a commercial weight management diet (i.e. low energy density) influences satiation, hunger and satiety and leads to lower energy intake during ad-libitum meals and over a full day. We further seek to demonstrate the sustainability of this effect following 12- week weight loss on the weight management program.
- We hypothesise that formulated (low energy) meals will lead to decreased hunger, greater fullness and reduced desire to eat compared to standard meals.
- We hypothesise that the commercial weight management program will lead to greater weight loss compared to control program.
- We hypothesise that formulated meals (high consumer acceptance) will improve hedonic control over eating (lower wanting for high fat food)
- We hypothesise that the commercial weight management program will improve hedonic control over eating (reduced experience food cravings)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Weight management programParticipants enrolled in commercial weight management program |
| Control group | Active comparator | Behavioral: Weight management programParticipants enrolled in standard care weight management provision |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI of 28 - 45 kg/m2
- Reporting an interest in weight loss, not actively participating in a commercial weight loss program,
- Not increased physical activity levels in the past 2-4 weeks
- Able to eat most everyday foods and fruits and vegetables
- Written informed consent to be given
Key exclusion criteria (15 listed)
- Significant health problems that could cause confounding effects between intervention and control.
- Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study
- Pregnant, planning to become pregnant or breastfeeding
- History of anaphylaxis to food
- Known food allergies or food intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight management program | Behavioural | Control group, Intervention Group |
Primary outcome
Test Meal Energy Intake
Time frame: Week 0 and week 12
Measured reductions in ad-libitum energy intake following consumption of formulated test meal in comparison to control.
24h Energy Intake
Time frame: Week 0 and week 12
Measured reduction in total within-day energy intake following consumption of formulated meals in comparison to control
Appetite sensations
Time frame: Week 0 and week 14
Measured reduction in hunger and increase in satiety quotient following consumption of formulated test meal in comparison to equi-energetic control
Food preference
Time frame: Week 0 and week 14
Measured changes in food preference and liking and wanting profiles for food (HF<LF) following consumption of formulated test meal in comparison to equi-energetic control
1 secondary outcome
Body Weight
Time frame: Weekly from week 0 to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Derived from this study: PubMed 31340872Buckland NJ, Camidge D, Croden F, Myers A, Lavin JH, Stubbs RJ, Blundell JE, Finlayson G. Women with a low-satiety phenotype show impaired appetite control and greater resistance to weight loss. Br J Nutr. 2019 Oct 28;122(8):951-959. doi: 10.1017/S000711451900179X.
- Derived from this study: PubMed 30053284Buckland NJ, Camidge D, Croden F, Lavin JH, Stubbs RJ, Hetherington MM, Blundell JE, Finlayson G. A Low Energy-Dense Diet in the Context of a Weight-Management Program Affects Appetite Control in Overweight and Obese Women. J Nutr. 2018 May 1;148(5):798-806. doi: 10.1093/jn/nxy041.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham S Finlayson, PhD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight management program in people with Overweight and Obesity, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test Meal Energy Intake (time frame: Week 0 and week 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02012426, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.