NCT02340793

Brief 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 Food Reintroduction, and Weight Loss Maintenance programmes. The study will incorporate three work packages with the aim of:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

2.1 years

First QC Date

December 19, 2014

Last Update Submit

January 17, 2018

Conditions

Obesity

Keywords

Weight loss

Outcome Measures

Primary Outcomes (4)

  • WP1: change in body composition with substantial, non-surgical, weight loss

    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

    Measurement of fat mass before and after a weight loss programme using MRI

    20 weeks

  • WP2: metabolic adaptation during weight loss and maintenance

    Change in resting metabolic rate before and after weight loss

    2 years

  • WP3: weight regain prevention

    % achieving \>15kg weight loss at 12 and 24 months

    2 years

Secondary Outcomes (6)

  • Muscle/fat mass of specific muscle groups

    20 weeks

  • Adherence and acceptability of Rescue Packages to Patients

    2 years

  • Metabolic adaptive effect of weight loss

    2 years

  • Weight regain prevention

    2 years

  • Weight regain prevention

    2 years

  • +1 more secondary outcomes

Study Arms (1)

Counterweight Plus Dietary Intervention

EXPERIMENTAL

Weight management programme including total diet replacement with soups and shakes; approximately 800 calories/day

Dietary Supplement: Counterweight Plus

Interventions

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.

Counterweight Plus Dietary Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glasgow Royal Infirmary

Glasgow, Scotland, G31 2ER, United Kingdom

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Michael EJ Lean, MA MB BChir MD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2014

First Posted

January 19, 2015

Study Start

January 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

January 19, 2018

Record last verified: 2018-01

Locations

GB(1)