Obesity Clinical Trial - BEYOND Weight Loss Study

Status Completed

Clinical 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 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).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02340793
Study type	Interventional
Source	NHS Greater Glasgow and Clyde
Contact
Status	Completed
Phase	N/A
Start date	January 2015
Completion date	February 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

BEYOND Weight Loss Study — BEYOND

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms