BEYOND Weight Loss Study (BEYOND)

January 17, 2018 updated by: NHS Greater Glasgow and Clyde

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.

The study will incorporate three work packages with the aim of:

  1. examining changes in body composition with substantial (target >15kg) non-surgical weight loss (work package 1, WP1)
  2. characterizing the metabolic adaptations during weight loss and maintenance (work package 2, WP2)
  3. examining Rescue Packages as a method of weight re-gain prevention (work package 3, WP3).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G31 2ER
        • Glasgow Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Counterweight Plus Dietary Intervention
Weight management programme including total diet replacement with soups and shakes; approximately 800 calories/day
Dietary supplement: Counterweight Plus
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
20 weeks
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
20 weeks
WP2: metabolic adaptation during weight loss and maintenance
Time Frame: 2 years
Change in resting metabolic rate before and after weight loss
2 years
WP3: weight regain prevention
Time Frame: 2 years
% achieving >15kg weight loss at 12 and 24 months
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle/fat mass of specific muscle groups
Time Frame: 20 weeks
Relationship between predicted muscle and fat mass with the strength of specific muscle groups (by muscle strength, gait analysis and WOMAC questionnaire)
20 weeks
Adherence and acceptability of Rescue Packages to Patients
Time Frame: 2 years
Number of participants requiring and completing rescue packages
2 years
Metabolic adaptive effect of weight loss
Time Frame: 2 years
Comparison of leptin, ghrelin and thyroid hormone levels at baseline to those during weight loss and maintenance to establish
2 years
Weight regain prevention
Time Frame: 2 years
changes in BED Questionnaire Rating Score
2 years
Weight regain prevention
Time Frame: 2 years
% undertaking Rescue Package during Weight Loss Maintenance
2 years
Weight regain prevention
Time Frame: 2 years
rate of weight regain during Weight Loss Maintenance
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NHS Greater Glasgow and Clyde

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Glasgow

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael EJ Lean, MA MB BChir MD, University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GN14RA448

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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