ObesityBEYONDNCT02340793
BEYOND Weight Loss Study
A study testing Counterweight Plus in people with Obesity, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
National guidelines recommend 15-20% weight loss for severe and complicated obesity. Weight loss maintenance can be achieved in around 33% of patients at 12 months. The BEYOND study will administer Counterweight Plus; a nutritionally replete Total Diet Replacement Plan (TDR) of 800+ Calories followed by structured… 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
- Obesity
- What is being tested?
- Counterweight Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Feb 2017
- 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
- confirmation from general practitioner (GP) of suitability for intervention
- written informed consent
- female
- BMI ≥30 kg/m2 and < 45kg/m2, weight<200 kg and <60 cm bore size
Who cannot join
- known illness such as heart disease, cancer, or any disability that would affect weight loss (diabetes not an exclusion) or prevent completion of the intervention
- implanted electronic devices that are MRI incompatible or MRI unsafe, ferromagnetic foreign bodies
- substance abuse
- myocardial infarction within previous 6 months
- learning difficulties and subjects having difficulty in understanding verbal or written English
- pregnant/ considering pregnancy
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- patients who have required hospitalisation for depression or are on antipsychotic drugs
- people currently participating in another clinical research trial
- recent weight loss >5kg within the last 6 months
- current treatment with anti-obesity drugs
- diagnosed eating disorder
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Glasgow Royal Infirmary
Glasgow, Scotland, G31 2ER
About this study
Official title: Body Composition and Energy Expenditure With Total Diet Replacement During Weight Loss and Maintenance
National guidelines recommend 15-20% weight loss for severe and complicated obesity. Weight loss maintenance can be achieved in around 33% of patients at 12 months.
The BEYOND study will administer Counterweight Plus; a nutritionally replete Total Diet Replacement Plan (TDR) of 800+ Calories followed by structured Food Reintroduction, and Weight Loss Maintenance programmes.
Read more
The study will incorporate three work packages with the aim of:
- examining changes in body composition with substantial (target >15kg) non-surgical weight loss (work package 1, WP1)
- characterizing the metabolic adaptations during weight loss and maintenance (work package 2, WP2)
- examining Rescue Packages as a method of weight re-gain prevention (work package 3, WP3).
Read the detailed description
All participants will receive the Counterweight Plus dietary intervention. This consists of:
- 12-20 weeks 800+ calories/day Total Diet Replacement Plan, followed by
- 6-8 weeks Food Reintroduction, followed by
- up to 104 weeks Weight Loss Maintenance, based on maintaining daily calorie restriction.
All participants will undergo the following investigations at baseline and at regular intervals throughout the study period:
- height (baseline only)
- whole body MRI scans: total-body skeletal muscle volume and fat mass will be measured using whole-body multi-slice MRI (baseline and 12 weeks only)
- functional assessment: completion of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) (baseline and 12 weeks only)
- gait and muscle strength assessment: biomechanical gait analysis will be carried out using an 8 camera VICON system during flat walking to determine maximum flexion and extension moments for both limbs and maximum adduction and abduction moments. Muscle strength will also be directly measured of both the upper (grip strength) and lower (quadriceps and hamstrings) limb using a dynamometer and myometer (baseline and 12 weeks only)
- anthropometric measurement: body weight; waist, hip, thigh, arm and calf circumferences
- indirect calorimetry: resting metabolic rate will be measured by a computerised open-circuit ventilated hood system
- fasting blood sampling: for measurement of HbA1C, lipid profile, leptin, thyroid hormones
- gut microbiota analysis from faecal samples
- Binge Eating Disorder and Quality of Life (EQ-5D) questionnaires
Participants will receive regular support/advice from a research dietician/ nutritionist during the two year study period.
- Conditions
- Obesity
- Being tested
- Counterweight Plus
- Keywords
- Weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counterweight PlusDietary supplement
A non-surgical, nutritionally replete weight management programme comprising a Total Diet Replacement Plan (TDR) of 800+ calories/day to produce a weight loss of >15kg over 12-20 weeks; followed by a structured Food Reintroduction phase for 6-8 weeks and a Weight Loss Maintenance phase; total intervention period 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Counterweight Plus Dietary Intervention | Experimental | Weight management programme including total diet replacement with soups and shakes; approximately 800 calories/day Receives: Dietary Supplement: Counterweight Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
WP1: change in body composition with substantial, non-surgical, weight loss
Measurement of muscle mass before and after a weight loss programme using MRI
Measured: 20 weeks
WP1: change in body composition with substantial, non-surgical, weight loss
Measurement of fat mass before and after a weight loss programme using MRI
Measured: 20 weeks
WP2: metabolic adaptation during weight loss and maintenance
Change in resting metabolic rate before and after weight loss
Measured: 2 years
WP3: weight regain prevention
% achieving >15kg weight loss at 12 and 24 months
Measured: 2 years
Secondary outcomes (6)
Muscle/fat mass of specific muscle groups
Relationship between predicted muscle and fat mass with the strength of specific muscle groups (by muscle strength, gait analysis and WOMAC questionnaire)
Measured: 20 weeks
Adherence and acceptability of Rescue Packages to Patients
Number of participants requiring and completing rescue packages
Measured: 2 years
Metabolic adaptive effect of weight loss
Comparison of leptin, ghrelin and thyroid hormone levels at baseline to those during weight loss and maintenance to establish
Measured: 2 years
Weight regain prevention
changes in BED Questionnaire Rating Score
Measured: 2 years
Weight regain prevention
% undertaking Rescue Package during Weight Loss Maintenance
Measured: 2 years
Weight regain prevention
rate of weight regain during Weight Loss Maintenance
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Michael EJ Lean, MA MB BChir MD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340793
- Sponsor's protocol ID
- GN14RA448
- Acronym
- BEYOND
- Status last verified
- Jan 2018
- First submitted
- 19 Dec 2014
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition and Energy Expenditure With Total Diet Replacement During Weight Loss and Maintenance
- ClinicalTrials.gov ID
- NCT02340793
- Acronym / sponsor ID
- BEYOND / GN14RA448
- Conditions
- Obesity
- Keywords
- Weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- Jan 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 19 Jan 2015 (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.
National guidelines recommend 15-20% weight loss for severe and complicated obesity. Weight loss maintenance can be achieved in around 33% of patients at 12 months.
The BEYOND study will administer Counterweight Plus; a nutritionally replete Total Diet Replacement Plan (TDR) of 800+ Calories followed by structured Food Reintroduction, and Weight Loss Maintenance programmes.
The study will incorporate three work packages with the aim of:
- examining changes in body composition with substantial (target >15kg) non-surgical weight loss (work package 1, WP1)
- characterizing the metabolic adaptations during weight loss and maintenance (work package 2, WP2)
- examining Rescue Packages as a method of weight re-gain prevention (work package 3, WP3).
Detailed description
All participants will receive the Counterweight Plus dietary intervention. This consists of:
- 12-20 weeks 800+ calories/day Total Diet Replacement Plan, followed by
- 6-8 weeks Food Reintroduction, followed by
- up to 104 weeks Weight Loss Maintenance, based on maintaining daily calorie restriction.
All participants will undergo the following investigations at baseline and at regular intervals throughout the study period:
- height (baseline only)
- whole body MRI scans: total-body skeletal muscle volume and fat mass will be measured using whole-body multi-slice MRI (baseline and 12 weeks only)
- functional assessment: completion of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) (baseline and 12 weeks only)
- gait and muscle strength assessment: biomechanical gait analysis will be carried out using an 8 camera VICON system during flat walking to determine maximum flexion and extension moments for both limbs and maximum adduction and abduction moments. Muscle strength will also be directly measured of both the upper (grip strength) and lower (quadriceps and hamstrings) limb using a dynamometer and myometer (baseline and 12 weeks only)
- anthropometric measurement: body weight; waist, hip, thigh, arm and calf circumferences
- indirect calorimetry: resting metabolic rate will be measured by a computerised open-circuit ventilated hood system
- fasting blood sampling: for measurement of HbA1C, lipid profile, leptin, thyroid hormones
- gut microbiota analysis from faecal samples
- Binge Eating Disorder and Quality of Life (EQ-5D) questionnaires
Participants will receive regular support/advice from a research dietician/ nutritionist during the two year study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Counterweight Plus Dietary Intervention | Experimental | Dietary Supplement: Counterweight PlusWeight management programme including total diet replacement with soups and shakes; approximately 800 calories/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- confirmation from general practitioner (GP) of suitability for intervention
- written informed consent
- female
- BMI ≥30 kg/m2 and < 45kg/m2, weight<200 kg and <60 cm bore size
Key exclusion criteria (11 listed)
- known illness such as heart disease, cancer, or any disability that would affect weight loss (diabetes not an exclusion) or prevent completion of the intervention
- implanted electronic devices that are MRI incompatible or MRI unsafe, ferromagnetic foreign bodies
- substance abuse
- myocardial infarction within previous 6 months
- learning difficulties and subjects having difficulty in understanding verbal or written English
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 |
|---|---|---|
| Counterweight PlusA non-surgical, nutritionally replete weight management programme comprising a Total Diet Replacement Plan (TDR) of 800+ calories/day to produce a weight loss of >15kg over 12-20 weeks; followed by a structured Food Reintroduction phase for 6-8 weeks and a Weight Loss Maintenance phase; total intervention period 2 years. | Dietary supplement | Counterweight Plus Dietary Intervention |
Primary outcome
WP1: change in body composition with substantial, non-surgical, weight loss
Time frame: 20 weeks
Measurement of muscle mass before and after a weight loss programme using MRI
WP1: change in body composition with substantial, non-surgical, weight loss
Time frame: 20 weeks
Measurement of fat mass before and after a weight loss programme using MRI
WP2: metabolic adaptation during weight loss and maintenance
Time frame: 2 years
Change in resting metabolic rate before and after weight loss
WP3: weight regain prevention
Time frame: 2 years
% achieving >15kg weight loss at 12 and 24 months
6 secondary outcomes
Muscle/fat mass of specific muscle groups
Time frame: 20 weeks
Adherence and acceptability of Rescue Packages to Patients
Time frame: 2 years
Metabolic adaptive effect of weight loss
Time frame: 2 years
Weight regain prevention
Time frame: 2 years
Weight regain prevention
Time frame: 2 years
Weight regain prevention
Time frame: 2 years
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 19 Jan 2018.
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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.
Michael EJ Lean, MA MB BChir MD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counterweight Plus in people with Obesity, run by NHS Greater Glasgow and Clyde 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 4 inclusion and 11 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 19 Jan 2018. 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?
WP1: change in body composition with substantial, non-surgical, weight loss (time frame: 20 weeks). 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?
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 19 Jan 2018.