Weight Loss and Physical Activity Lifestyle Interventions In Post Liver And Kidney Transplants
NCT ID: NCT06249477
Last Updated: 2024-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2022-02-28
2023-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Control group
Patients receive a wrist activity monitor and a scale. They are also followed with monthly calls ensuring adequate functioning of devices and receiving case-specific nutritional guidance.
Wrist activity tracker and scale
Wrist activity tracker used to evaluate number of steps, heart rate, and frequency of usage of the devices to monitor activity. Scale used to record a patient's weight value.
Group intervention group
In addition to receiving a wrist activity monitor, scale, and being followed with monthly calls, patients in this arm received every other month nutritional coaching group sessions on topics related to nutrition and physical activity to promote education and lifestyle changes
Wrist activity tracker and scale
Wrist activity tracker used to evaluate number of steps, heart rate, and frequency of usage of the devices to monitor activity. Scale used to record a patient's weight value.
Nutritional Coaching group sessions
Nutritional coaching group sessions held via zoom and performed by a certified clinical nutritionist regarding nutrition, and physical activity specific for weight loss.
Interventions
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Wrist activity tracker and scale
Wrist activity tracker used to evaluate number of steps, heart rate, and frequency of usage of the devices to monitor activity. Scale used to record a patient's weight value.
Nutritional Coaching group sessions
Nutritional coaching group sessions held via zoom and performed by a certified clinical nutritionist regarding nutrition, and physical activity specific for weight loss.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI \>=30
* 6 months to 10 years post-transplant
* Stable immunosuppression as defined by no treatment for rejection in the past 3 months
* Access to Smartphone or computer
* Able to provide informed consent
Exclusion Criteria
* Any type of other prior transplant
* Age \<= 18 years old
* Treatment for rejection within the last 3 months
* Major infection requiring hospitalization within the last 3 months
* Relisting for liver transplant or returned to dialysis for kidney transplant
* Physical inability to participate in lifestyle intervention activity recommendations
* Patients that are actively enrolled in a weight center program
18 Years
ALL
No
Sponsors
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American Society of Transplantation
UNKNOWN
Massachusetts General Hospital
OTHER
Responsible Party
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Leigh Anne Dageforde
Assistant Professor of Surgery
Principal Investigators
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Leigh A Dageforde, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts
Boston, Massachusetts, United States
Countries
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References
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Estes C, Razavi H, Loomba R, Younossi Z, Sanyal AJ. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology. 2018 Jan;67(1):123-133. doi: 10.1002/hep.29466. Epub 2017 Dec 1.
Saeed N, Glass L, Sharma P, Shannon C, Sonnenday CJ, Tincopa MA. Incidence and Risks for Nonalcoholic Fatty Liver Disease and Steatohepatitis Post-liver Transplant: Systematic Review and Meta-analysis. Transplantation. 2019 Nov;103(11):e345-e354. doi: 10.1097/TP.0000000000002916.
Germani G, Laryea M, Rubbia-Brandt L, Egawa H, Burra P, O'Grady J, Watt KD. Management of Recurrent and De Novo NAFLD/NASH After Liver Transplantation. Transplantation. 2019 Jan;103(1):57-67. doi: 10.1097/TP.0000000000002485.
Wang X, Li J, Riaz DR, Shi G, Liu C, Dai Y. Outcomes of liver transplantation for nonalcoholic steatohepatitis: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2014 Mar;12(3):394-402.e1. doi: 10.1016/j.cgh.2013.09.023. Epub 2013 Sep 25.
Cotter TG, Charlton M. Nonalcoholic Steatohepatitis After Liver Transplantation. Liver Transpl. 2020 Jan;26(1):141-159. doi: 10.1002/lt.25657. Epub 2019 Nov 25.
Wadden TA, Brownell KD, Foster GD. Obesity: responding to the global epidemic. J Consult Clin Psychol. 2002 Jun;70(3):510-25. doi: 10.1037//0022-006x.70.3.510.
O'Brien T, Russell CL, Tan A, Mion L, Rose K, Focht B, Daloul R, Hathaway D. A Pilot Randomized Controlled Trial Using SystemCHANGE Approach to Increase Physical Activity in Older Kidney Transplant Recipients. Prog Transplant. 2020 Dec;30(4):306-314. doi: 10.1177/1526924820958148. Epub 2020 Sep 10.
Neale J, Smith AC. Cardiovascular risk factors following renal transplant. World J Transplant. 2015 Dec 24;5(4):183-95. doi: 10.5500/wjt.v5.i4.183.
Chen G, Gao L, Li X. Effects of exercise training on cardiovascular risk factors in kidney transplant recipients: a systematic review and meta-analysis. Ren Fail. 2019 Nov;41(1):408-418. doi: 10.1080/0886022X.2019.1611602.
Andres A, Saldana C, Gomez-Benito J. The transtheoretical model in weight management: validation of the processes of change questionnaire. Obes Facts. 2011;4(6):433-42. doi: 10.1159/000335135. Epub 2011 Nov 25.
Andres A, Saldana C, Gomez-Benito J. Establishing the stages and processes of change for weight loss by consensus of experts. Obesity (Silver Spring). 2009 Sep;17(9):1717-23. doi: 10.1038/oby.2009.100. Epub 2009 Apr 9.
Steinberg DM, Bennett GG, Askew S, Tate DF. Weighing every day matters: daily weighing improves weight loss and adoption of weight control behaviors. J Acad Nutr Diet. 2015 Apr;115(4):511-8. doi: 10.1016/j.jand.2014.12.011. Epub 2015 Feb 12.
Palmeira AL, Teixeira PJ, Branco TL, Martins SS, Minderico CS, Barata JT, Serpa SO, Sardinha LB. Predicting short-term weight loss using four leading health behavior change theories. Int J Behav Nutr Phys Act. 2007 Apr 20;4:14. doi: 10.1186/1479-5868-4-14.
Takacs J, Pollock CL, Guenther JR, Bahar M, Napier C, Hunt MA. Validation of the Fitbit One activity monitor device during treadmill walking. J Sci Med Sport. 2014 Sep;17(5):496-500. doi: 10.1016/j.jsams.2013.10.241. Epub 2013 Oct 31.
Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
Related Links
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World Health Organization \[WHO\]. (2014). Obesity and Overweight. Fact Sheet N 311, Geneva: World Health Organization.
Other Identifiers
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2021P003412
Identifier Type: -
Identifier Source: org_study_id
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