NCT02340793

BEYOND Weight Loss Study

Body Composition and Energy Expenditure With Total Diet Replacement During Weight Loss and Maintenance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: NHS Greater Glasgow and Clyde · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2015-01-19
• Last updated: 2018-01-19

Locations

1 site across 1 country: United Kingdom