Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-04-29 @ 1:14 AM
Study NCT ID:
NCT02340793
Status:
COMPLETED
Last Update Posted:
2018-01-19
First Post:
2014-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BEYOND Weight Loss Study
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
Study Overview
Official Title:
Body Composition and Energy Expenditure With Total Diet Replacement During Weight Loss and Maintenance
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEYOND
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. 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).
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: