ObesityNCT03214471
Evaluation of a Lifestyle Intervention After Bariatric Surgery
A study testing Lifestyle intervention in people with Obesity, run by University College, London at 1 site in United Kingdom.
Trial summary
The aim of this trial is to evaluate the effect of a post-surgery 12-month lifestyle intervention compared to usual care upon post-surgery weight loss and changes that occur in body composition (relative amounts of body fat, muscle and bone), physical fitness and activity levels, diseases linked to obesity (e.g. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Feb 2018to 21 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged between 18 to 65 years old.
- Planned to undergo either primary gastric bypass surgery or primary sleeve gastrectomy surgery and fulfilling NICE eligibility criteria for bariatric surgery.
- Medically safe to participate in exercise programme.
- Able to read and write in English.
- Willing and able to provide written informed consent.
- Able to comply with study protocol.
- Able to attend a supervised tailored exercise session at UCLH weekly for 12 weeks.
- Willing and able to wear a Fitbit wrist-based activity tracker device and an Actigraph device.
Who cannot join
- More than 200 kg of body weight (due to limitation of DXA Scanner).
- Non-ambulatory.
- Functional limitation.
- Medical contraindication for exercise.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
About this study
Official title: Evaluation of the Effect of a Lifestyle Intervention Compared to Usual Care on Weight Loss and Changes in Body Composition, Physical Activity Levels and Health-related Quality of Life in the First Year Following Bariatric Surgery
The aim of this trial is to evaluate the effect of a post-surgery 12-month lifestyle intervention compared to usual care upon post-surgery weight loss and changes that occur in body composition (relative amounts of body fat, muscle and bone), physical fitness and activity levels, diseases linked to obesity (e.g. diabetes, high blood pressure, high cholesterol level, sleep apnoea) and health-related quality of life (HRQoL) over a 12-month period.
Read the detailed description
People with severe obesity who are scheduled to undergo either primary gastric bypass or primary sleeve gastrectomy will be recruited from the Bariatric Clinics at University College London Hospital (UCLH) and the Whittington Hospital and asked to participate in an observational cohort study. Eligible patients will be given a participant information sheet (PIS) for BARI-LIFESTYLE Observational Study and informed consent will be sought. Recruited patient will attend for 4 research visits, timed to coincide with their clinic visits, at approximately 6 weeks before surgery (Visit 1), 3 month post-surgery (Visit 2), 6 months post-surgery (Visit 3) and 12 months post-surgery (Visit 4). Each research visit will include assessment of body weight, body composition (using bioelectrical impedance analysis), physical fitness and activity levels, obesity-associated co-morbidities, HRQoL and usual care laboratory investigations. Dual energy X-ray absorptiometry (DXA) scanning will be undertaken at Visit 1 and Visit 4, which is not a usual assessment for the post-surgery standard care. All of the research assessments will be done as part of this observational cohort study.
Immediately after surgery has been undertaken, BARI-LIFESTYLE Observational Study participants will be randomised to continue to receive usual care, or usual care plus lifestyle intervention (nutritional and behavioural tele-counselling, self-monitoring and a 12-week supervised tailored exercise programme). However, to avoid contamination between the intervention group and the usual care group, only those randomly allocated to the lifestyle intervention group will be informed of this. They will be given a PIS (BARI-LIFESTYLE Intervention Study) and informed consent will be sought. If the participants decline to take part in the lifestyle programme, they will remain in the control group (observational cohort study).
- Conditions
- Obesity
- Being tested
- Lifestyle intervention
- Keywords
- bariatric surgery, healthy lifestyle
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
Nutritional and behavioural tele-counselling , self-monitoring and a 12-week supervised tailored exercise programme. Participants will receive a regular tele-counselling throughout the 12-month. Each session will take approximately 15 minutes, underpinned by behavioural psychological techniques. After their 3-month post-surgery assessment visit, participants in the BARI-LIFESTYLE Intervention Study will be enrolled in a supervised exercise programme at health facility gyms for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | usual care provided by the NHS for patients undergoing bariatric surgery. |
| Intervention | Experimental | usual care + BARI-LIFESTYLE intervention Receives: Behavioral: Lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
%WL
The primary objective of this trial is to compare the 1-year post-surgery percentage weight loss (%WL) in people receiving usual care and people receiving a post-operative lifestyle intervention programme.
Measured: 52 weeks
Secondary outcomes (13)
body fat
To compare post-surgery changes in body fat assessed using DXA scanning relative to pre-surgery at 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme.
Measured: 52 weeks
bone mineral density
To compare post-surgery changes in bone mineral density assessed using DXA scanning relative to pre-surgery at 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme.
Measured: 52 weeks
skeletal muscle mass
To compare post-surgery changes in skeletal muscle mass, relative to pre-surgery at 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme.
Measured: 52 weeks
physical activity (PA) levels
To compare post-surgery changes in physical activity (PA) levels (light, moderate, vigorous) at 3, 6, and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme using Actigraph assessments.
Measured: 12, 26 and 52 weeks
150 minutes of activity
To compare post-surgery changes in percentage achieving 150 minutes of moderate to vigorous PA (MVPA) in a week at 3, 6, and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme using Actigraph assessments.
Measured: 12, 26 and 52 weeks
sedentary time
To compare post-surgery changes in sedentary time at 3, 6, and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme using Actigraph assessments.
Measured: 12, 26 and 52 weeks
6MWT
To compare post-surgery changes in physical fitness assessed using 6-minute walk tests (6MWT) at 3, 6 and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme.
Measured: 12, 26 and 52 weeks
STS
To compare post-surgery changes in physical fitness assessed using sit-to-stand (STS) test at 3, 6 and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme.
Measured: 12, 26 and 52 weeks
Handgrip test
To compare post-surgery changes in handgrip test at 3, 6 and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme.
Measured: 12, 26 and 52 weeks
36-Item Short-Form Health Survey Instrument (SF-36)
To compare post-surgery changes in health-related quality of life.
Measured: 12, 26 and 52 weeks
Impact of Weight on Quality of Life-Lite (IWQOL-Lite)
To compare post-surgery changes in health-related quality of life.
Measured: 12, 26 and 52 weeks
Beck Depression Inventory (BDI)
To compare post-surgery changes in characteristics of attitude and symptoms of depression assessed using Beck Depression Inventory (BDI) at 3, 6 and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme.
Measured: 12, 26 and 52 weeks
Medical history
To compare post-surgery changes in obesity-associated comorbidities (type 2 diabetes, dyslipidaemia, hypertension, obstructive sleep apnoea) at 3, 6 and 12 months post-surgery in people receiving usual care and people receiving a post-operative lifestyle intervention programme.
Measured: 12, 26 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start20 Feb 2018
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial will be a two-arm, parallel group, single-blinded, single site RCT (embedded within an observational cohort study) conducted in London, United Kingdom (UK). A two-staged randomised consent design will be applied (See 8.2 Randomisation procedures). Recruitment will take place at the Bariatric Centre for Weight Management and Metabolic Surgery, University College London Hospitals (UCLH) and the Bariatric and Obesity Surgery Clinic at the Whittington Hospital. The trial will be carried out by the Centre for Obesity Research, Division of Medicine, University College London (UCL) at UCLH, which will be commenced in August 2017 with the expected total duration of 36 months. The total duration of each participation in the trial is approximately 12-16 months (12 months from the day of surgery). All participants will have to attend 4 research visits; baseline visit (approximately 6 weeks before surgery), then at approximately 3, 6, and 12-month post-surgery.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel L Batterham, PhD FRCP, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214471
- Sponsor's protocol ID
- 16/0232
- Status last verified
- Apr 2021
- First submitted
- 6 Jul 2017
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be discussed
Publications
Gloy VL, Briel M, Bhatt DL, Kashyap SR, Schauer PR, Mingrone G, Bucher HC, Nordmann AJ. Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials. BMJ. 2013 Oct 22;347:f5934. doi: 10.1136/bmj.f5934.
PubMed 24149519Purnell JQ, Selzer F, Wahed AS, Pender J, Pories W, Pomp A, Dakin G, Mitchell J, Garcia L, Staten MA, McCloskey C, Cummings DE, Flum DR, Courcoulas A, Wolfe BM. Type 2 Diabetes Remission Rates After Laparoscopic Gastric Bypass and Gastric Banding: Results of the Longitudinal Assessment of Bariatric Surgery Study. Diabetes Care. 2016 Jul;39(7):1101-7. doi: 10.2337/dc15-2138.
PubMed 27289123National Clinical Guideline Centre (UK). Obesity: Identification, Assessment and Management of Overweight and Obesity in Children, Young People and Adults: Partial Update of CG43. London: National Institute for Health and Care Excellence (NICE); 2014 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK264165/
PubMed 25535639Manning S, Pucci A, Carter NC, Elkalaawy M, Querci G, Magno S, Tamberi A, Finer N, Fiennes AG, Hashemi M, Jenkinson AD, Anselmino M, Santini F, Adamo M, Batterham RL. Early postoperative weight loss predicts maximal weight loss after sleeve gastrectomy and Roux-en-Y gastric bypass. Surg Endosc. 2015 Jun;29(6):1484-91. doi: 10.1007/s00464-014-3829-7. Epub 2014 Sep 20.
PubMed 25239175Tamboli RA, Hossain HA, Marks PA, Eckhauser AW, Rathmacher JA, Phillips SE, Buchowski MS, Chen KY, Abumrad NN. Body composition and energy metabolism following Roux-en-Y gastric bypass surgery. Obesity (Silver Spring). 2010 Sep;18(9):1718-24. doi: 10.1038/oby.2010.89. Epub 2010 Apr 22.
PubMed 20414197Giusti V, Theytaz F, Di Vetta V, Clarisse M, Suter M, Tappy L. Energy and macronutrient intake after gastric bypass for morbid obesity: a 3-y observational study focused on protein consumption. Am J Clin Nutr. 2016 Jan;103(1):18-24. doi: 10.3945/ajcn.115.111732. Epub 2015 Dec 16.
PubMed 26675775Janssen I, Fortier A, Hudson R, Ross R. Effects of an energy-restrictive diet with or without exercise on abdominal fat, intermuscular fat, and metabolic risk factors in obese women. Diabetes Care. 2002 Mar;25(3):431-8. doi: 10.2337/diacare.25.3.431.
PubMed 11874926Bond DS, Unick JL, Jakicic JM, Vithiananthan S, Pohl D, Roye GD, Ryder BA, Sax HC, Giovanni J, Wing RR. Objective assessment of time spent being sedentary in bariatric surgery candidates. Obes Surg. 2011 Jun;21(6):811-4. doi: 10.1007/s11695-010-0151-x.
PubMed 20393808Egberts K, Brown WA, Brennan L, O'Brien PE. Does exercise improve weight loss after bariatric surgery? A systematic review. Obes Surg. 2012 Feb;22(2):335-41. doi: 10.1007/s11695-011-0544-5.
PubMed 22038571Jassil FC, Manning S, Lewis N, Steinmo S, Kingett H, Lough F, Pucci AB, Cheung WH, Finer N, Walker J, Doyle J, Batterham RL. Feasibility and Impact of a Combined Supervised Exercise and Nutritional-Behavioral Intervention following Bariatric Surgery: A Pilot Study. J Obes. 2015;2015:693829. doi: 10.1155/2015/693829. Epub 2015 Jun 23.
PubMed 26199740Coen PM, Menshikova EV, Distefano G, Zheng D, Tanner CJ, Standley RA, Helbling NL, Dubis GS, Ritov VB, Xie H, Desimone ME, Smith SR, Stefanovic-Racic M, Toledo FG, Houmard JA, Goodpaster BH. Exercise and Weight Loss Improve Muscle Mitochondrial Respiration, Lipid Partitioning, and Insulin Sensitivity After Gastric Bypass Surgery. Diabetes. 2015 Nov;64(11):3737-50. doi: 10.2337/db15-0809. Epub 2015 Aug 20.
PubMed 26293505Sharman M, Hensher M, Wilkinson S, Williams D, Palmer A, Venn A, Ezzy D. What are the support experiences and needs of patients who have received bariatric surgery? Health Expect. 2017 Feb;20(1):35-46. doi: 10.1111/hex.12423. Epub 2015 Nov 2.
PubMed 28052539Pouwels S, Wit M, Teijink JA, Nienhuijs SW. Aspects of Exercise before or after Bariatric Surgery: A Systematic Review. Obes Facts. 2015;8(2):132-46. doi: 10.1159/000381201.
PubMed 25895670Bradley C. Designing medical and educational intervention studies. A review of some alternatives to conventional randomized controlled trials. Diabetes Care. 1993 Feb;16(2):509-18. doi: 10.2337/diacare.16.2.509.
PubMed 8432226Stott DJ, Langhorne P, Rodgers H. Informed consent. Two stage randomisation and consent would overcome many problems. BMJ. 1997 Jul 26;315(7102):253. No abstract available.
PubMed 9253294
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Lifestyle Intervention Compared to Usual Care on Weight Loss and Changes in Body Composition, Physical Activity Levels and Health-related Quality of Life in the First Year Following Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03214471
- Acronym / sponsor ID
- 16/0232
- Conditions
- Obesity
- Keywords
- bariatric surgery, healthy lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this trial is to evaluate the effect of a post-surgery 12-month lifestyle intervention compared to usual care upon post-surgery weight loss and changes that occur in body composition (relative amounts of body fat, muscle and bone), physical fitness and activity levels, diseases linked to obesity (e.g. diabetes, high blood pressure, high cholesterol level, sleep apnoea) and health-related quality of life (HRQoL) over a 12-month period.
Detailed description
People with severe obesity who are scheduled to undergo either primary gastric bypass or primary sleeve gastrectomy will be recruited from the Bariatric Clinics at University College London Hospital (UCLH) and the Whittington Hospital and asked to participate in an observational cohort study. Eligible patients will be given a participant information sheet (PIS) for BARI-LIFESTYLE Observational Study and informed consent will be sought. Recruited patient will attend for 4 research visits, timed to coincide with their clinic visits, at approximately 6 weeks before surgery (Visit 1), 3 month post-surgery (Visit 2), 6 months post-surgery (Visit 3) and 12 months post-surgery (Visit 4). Each research visit will include assessment of body weight, body composition (using bioelectrical impedance analysis), physical fitness and activity levels, obesity-associated co-morbidities, HRQoL and usual care laboratory investigations. Dual energy X-ray absorptiometry (DXA) scanning will be undertaken at Visit 1 and Visit 4, which is not a usual assessment for the post-surgery standard care. All of the research assessments will be done as part of this observational cohort study.
Immediately after surgery has been undertaken, BARI-LIFESTYLE Observational Study participants will be randomised to continue to receive usual care, or usual care plus lifestyle intervention (nutritional and behavioural tele-counselling, self-monitoring and a 12-week supervised tailored exercise programme). However, to avoid contamination between the intervention group and the usual care group, only those randomly allocated to the lifestyle intervention group will be informed of this. They will be given a PIS (BARI-LIFESTYLE Intervention Study) and informed consent will be sought. If the participants decline to take part in the lifestyle programme, they will remain in the control group (observational cohort study).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The trial will be a two-arm, parallel group, single-blinded, single site RCT (embedded within an observational cohort study) conducted in London, United Kingdom (UK). A two-staged randomised consent design will be applied (See 8.2 Randomisation procedures). Recruitment will take place at the Bariatric Centre for Weight Management and Metabolic Surgery, University College London Hospitals (UCLH) and the Bariatric and Obesity Surgery Clinic at the Whittington Hospital. The trial will be carried out by the Centre for Obesity Research, Division of Medicine, University College London (UCL) at UCLH, which will be commenced in August 2017 with the expected total duration of 36 months. The total duration of each participation in the trial is approximately 12-16 months (12 months from the day of surgery). All participants will have to attend 4 research visits; baseline visit (approximately 6 weeks before surgery), then at approximately 3, 6, and 12-month post-surgery.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –usual care provided by the NHS for patients undergoing bariatric surgery. |
| Intervention | Experimental | Behavioral: Lifestyle interventionusual care + BARI-LIFESTYLE intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult aged between 18 to 65 years old.
- Planned to undergo either primary gastric bypass surgery or primary sleeve gastrectomy surgery and fulfilling NICE eligibility criteria for bariatric surgery.
- Medically safe to participate in exercise programme.
- Able to read and write in English.
- Willing and able to provide written informed consent.
Key exclusion criteria (4 listed)
- More than 200 kg of body weight (due to limitation of DXA Scanner).
- Non-ambulatory.
- Functional limitation.
- Medical contraindication for exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle interventionNutritional and behavioural tele-counselling , self-monitoring and a 12-week supervised tailored exercise programme. Participants will receive a regular tele-counselling throughout the 12-month. Each session will take approximately 15 minutes, underpinned by behavioural psychological techniques. After their 3-month post-surgery assessment visit, participants in the BARI-LIFESTYLE Intervention Study will be enrolled in a supervised exercise programme at health facility gyms for 12 weeks. | Behavioural | Intervention |
Primary outcome
%WL
Time frame: 52 weeks
The primary objective of this trial is to compare the 1-year post-surgery percentage weight loss (%WL) in people receiving usual care and people receiving a post-operative lifestyle intervention programme.
13 secondary outcomes
body fat
Time frame: 52 weeks
bone mineral density
Time frame: 52 weeks
skeletal muscle mass
Time frame: 52 weeks
physical activity (PA) levels
Time frame: 12, 26 and 52 weeks
150 minutes of activity
Time frame: 12, 26 and 52 weeks
sedentary time
Time frame: 12, 26 and 52 weeks
6MWT
Time frame: 12, 26 and 52 weeks
STS
Time frame: 12, 26 and 52 weeks
Handgrip test
Time frame: 12, 26 and 52 weeks
36-Item Short-Form Health Survey Instrument (SF-36)
Time frame: 12, 26 and 52 weeks
Impact of Weight on Quality of Life-Lite (IWQOL-Lite)
Time frame: 12, 26 and 52 weeks
Beck Depression Inventory (BDI)
Time frame: 12, 26 and 52 weeks
Medical history
Time frame: 12, 26 and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 24149519Gloy VL, Briel M, Bhatt DL, Kashyap SR, Schauer PR, Mingrone G, Bucher HC, Nordmann AJ. Bariatric surgery versus non-surgical treatment for obesity: a systematic review and meta-analysis of randomised controlled trials. BMJ. 2013 Oct 22;347:f5934. doi: 10.1136/bmj.f5934.
- Background: PubMed 27289123Purnell JQ, Selzer F, Wahed AS, Pender J, Pories W, Pomp A, Dakin G, Mitchell J, Garcia L, Staten MA, McCloskey C, Cummings DE, Flum DR, Courcoulas A, Wolfe BM. Type 2 Diabetes Remission Rates After Laparoscopic Gastric Bypass and Gastric Banding: Results of the Longitudinal Assessment of Bariatric Surgery Study. Diabetes Care. 2016 Jul;39(7):1101-7. doi: 10.2337/dc15-2138.
- Background: PubMed 25535639National Clinical Guideline Centre (UK). Obesity: Identification, Assessment and Management of Overweight and Obesity in Children, Young People and Adults: Partial Update of CG43. London: National Institute for Health and Care Excellence (NICE); 2014 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK264165/
- Background: PubMed 25239175Manning S, Pucci A, Carter NC, Elkalaawy M, Querci G, Magno S, Tamberi A, Finer N, Fiennes AG, Hashemi M, Jenkinson AD, Anselmino M, Santini F, Adamo M, Batterham RL. Early postoperative weight loss predicts maximal weight loss after sleeve gastrectomy and Roux-en-Y gastric bypass. Surg Endosc. 2015 Jun;29(6):1484-91. doi: 10.1007/s00464-014-3829-7. Epub 2014 Sep 20.
- Background: PubMed 20414197Tamboli RA, Hossain HA, Marks PA, Eckhauser AW, Rathmacher JA, Phillips SE, Buchowski MS, Chen KY, Abumrad NN. Body composition and energy metabolism following Roux-en-Y gastric bypass surgery. Obesity (Silver Spring). 2010 Sep;18(9):1718-24. doi: 10.1038/oby.2010.89. Epub 2010 Apr 22.
- Background: PubMed 26675775Giusti V, Theytaz F, Di Vetta V, Clarisse M, Suter M, Tappy L. Energy and macronutrient intake after gastric bypass for morbid obesity: a 3-y observational study focused on protein consumption. Am J Clin Nutr. 2016 Jan;103(1):18-24. doi: 10.3945/ajcn.115.111732. Epub 2015 Dec 16.
- Background: PubMed 11874926Janssen I, Fortier A, Hudson R, Ross R. Effects of an energy-restrictive diet with or without exercise on abdominal fat, intermuscular fat, and metabolic risk factors in obese women. Diabetes Care. 2002 Mar;25(3):431-8. doi: 10.2337/diacare.25.3.431.
- Background: PubMed 20393808Bond DS, Unick JL, Jakicic JM, Vithiananthan S, Pohl D, Roye GD, Ryder BA, Sax HC, Giovanni J, Wing RR. Objective assessment of time spent being sedentary in bariatric surgery candidates. Obes Surg. 2011 Jun;21(6):811-4. doi: 10.1007/s11695-010-0151-x.
- Background: PubMed 22038571Egberts K, Brown WA, Brennan L, O'Brien PE. Does exercise improve weight loss after bariatric surgery? A systematic review. Obes Surg. 2012 Feb;22(2):335-41. doi: 10.1007/s11695-011-0544-5.
- Background: PubMed 26199740Jassil FC, Manning S, Lewis N, Steinmo S, Kingett H, Lough F, Pucci AB, Cheung WH, Finer N, Walker J, Doyle J, Batterham RL. Feasibility and Impact of a Combined Supervised Exercise and Nutritional-Behavioral Intervention following Bariatric Surgery: A Pilot Study. J Obes. 2015;2015:693829. doi: 10.1155/2015/693829. Epub 2015 Jun 23.
- Background: PubMed 26293505Coen PM, Menshikova EV, Distefano G, Zheng D, Tanner CJ, Standley RA, Helbling NL, Dubis GS, Ritov VB, Xie H, Desimone ME, Smith SR, Stefanovic-Racic M, Toledo FG, Houmard JA, Goodpaster BH. Exercise and Weight Loss Improve Muscle Mitochondrial Respiration, Lipid Partitioning, and Insulin Sensitivity After Gastric Bypass Surgery. Diabetes. 2015 Nov;64(11):3737-50. doi: 10.2337/db15-0809. Epub 2015 Aug 20.
- Background: PubMed 28052539Sharman M, Hensher M, Wilkinson S, Williams D, Palmer A, Venn A, Ezzy D. What are the support experiences and needs of patients who have received bariatric surgery? Health Expect. 2017 Feb;20(1):35-46. doi: 10.1111/hex.12423. Epub 2015 Nov 2.
- Individual participant dataSharing planned: No. To be discussed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel L Batterham, PhD FRCP principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Obesity, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
%WL (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03214471, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.