BEYOND Weight Loss Study
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

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).
    

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.
    

Intervention name(s): Counterweight Plus
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight loss