Weight Loss and Physical Activity Lifestyle Interventions In Post Liver And Kidney Transplants

Weight Loss Clinical Trial

Official title:

Weight Loss and Physical Activity Lifestyle Interventions In Post Liver And Kidney Transplants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06249477
• Other study ID #: 2021P003412
• Status: Completed
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: January 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research project seeks to learn more about how lifestyle interventions can help liver and kidney transplant recipients achieve weight loss goals. The investigators want to evaluate if an intervention using weight and activity wrist monitors, as well as nutritional coaching group sessions is acceptable and useful for post-transplant patients aiming for weight loss. All participants will be given a wrist activity monitor, and a scale. Half of participants will be invited to participate in the nutritional coaching group sessions. The research team will look at weight loss, devices' usage, and satisfaction, and see if there are any difference among the two groups.

Description:

This project aims to understand feasibility, acceptability, and appropriateness of using connected health services (use of Fitbit and Scale), and nutritional coaching group sessions as a lifestyle intervention for post-transplant patients seeking weight loss. Secondarily, the investigators aim to assess effectiveness of the intervention to generate weight loss. Enrolled patients will receive a wrist activity tracker (Fitbit Charge 4) and a scale, of which information synchronizes to the electronic health record. Steps, usage, and weight values will be recorded and analyzed from the devices. All patients will be followed with monthly calls to assess issues with devices, and address case-specific questions. Simultaneously, half of the patients will be randomized to receive every other month nutritional coaching group sessions on topics related to nutrition and physical activity. Patients will have an in-person follow-up appointment where laboratory values, body measurements, and physical and mental readiness for weight loss surveys and scales will be applied at 6 and 12-months. Patients that don't accomplish weight loss goal at 6 months will be invited to cross over to the nutritional coaching group sessions intervention arm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prior liver or kidney transplant recipient

• 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:

• Dual and/or simultaneous organ kidney and liver transplant

• 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

Related Conditions & MeSH terms

• Body Weight
• Lifestyle Factors
• Weight Loss

Intervention

Device:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Society of Transplantation

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of intervention	The Feasibility of Intervention Measurement (FIM) is a previously-validated survey tool used in implementation science, and answered by participants, that uses a Likert scale from 1 to 5 to evaluate feasibility of the proposed intervention. A score greater than or equal to 4 is considered acceptable feasibility.	12 months (All study duration)
Primary	Acceptability of intervention	The Acceptability of Intervention Measurement (AIM) is a previously-validated survey tool used in implementation science, and answered by participants, that uses a Likert scale from 1 to 5 to evaluate acceptability of the proposed intervention. A score greater than or equal to 4 is considered adequate acceptability.	12 months (All study duration)
Primary	Rate of highly satisfied Patients	Patient-completed satisfaction questionnaires will be evaluated using a Likert scale from 1 to 5 with five being very satisfied and one being very unsatisfied. Satisfaction surveys were asked separately for the use of devices (Fitbit and smart scale), every other month follow-up calls, and every other month group sessions. An additional overall satisfaction score was also obtained for the entire intervention. High satisfaction will be considered the proportion of "somewhat satisfied" and "very satisfied" answers.	12 months (All study duration)
Primary	Wrist activity tracker usage rate	Usage rate will be calculated as the proportion of days in which steps are logged in relation to the number of days per month.	12 months (All study duration)
Secondary	Weight change percentage	Target Weight change percentage will be considered a greater than or equal to 2.5% loss at 6 months, and greater than or equal to 5% weight loss over the course of the 12-month period.	12 months (All study duration)

External Links

•   World Health Organization [WHO]. (2014). Obesity and Overweight. Fact Sheet N 311, Geneva: World Health Organization.