BEYOND Weight Loss Study
NCT02340793 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2018-01-19
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. 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).
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
University of Glasgow
collaborator OTHER -
NHS Greater Glasgow and Clyde
lead OTHER
Principal Investigators
-
Michael EJ Lean, MA MB BChir MD · University of Glasgow
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2017-02-28
- Completion
- 2017-02-28
Countries
- United Kingdom
Study Locations
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