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

NCT06249477 | Completed

• 1 other identifier: 2021P003412
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Weight Loss; Lifestyle Factors

Keywords

Transplant; Weight loss; Lifestyle intervention; Obesity management

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (1)

• Weight change percentage

  12 months (All study duration)

Study Arms (2)

Control group

OTHER

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.

Device: Wrist activity tracker and scale

Group intervention group

EXPERIMENTAL

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

Device: Wrist activity tracker and scale; Behavioral: Nutritional Coaching group sessions

Interventions

Wrist activity tracker and scale DEVICE

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.

Also known as: Fitbit Charge 4

Control group; Group intervention group

Nutritional Coaching group sessions BEHAVIORAL

Nutritional coaching group sessions held via zoom and performed by a certified clinical nutritionist regarding nutrition, and physical activity specific for weight loss.

Group intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior liver or kidney transplant recipient
• BMI \>=30
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Society of Transplantation: collaborator

Study Sites (1)

Massachusetts

Boston, Massachusetts, 02115, United States

Location

Related Publications (15)

• 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.

  PMID: 28802062 BACKGROUND

• 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.

  PMID: 31415032 BACKGROUND

• 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.

  PMID: 30335694 BACKGROUND

• 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.

  PMID: 24076414 BACKGROUND

• 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.

  PMID: 31610081 BACKGROUND

• 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.

  PMID: 12090366 BACKGROUND

• 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.

  PMID: 32912051 BACKGROUND

• 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.

  PMID: 26722646 BACKGROUND

• 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.

  PMID: 31106657 BACKGROUND

• 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.

  PMID: 22248993 BACKGROUND

• 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.

  PMID: 19360014 BACKGROUND

• 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.

  PMID: 25683820 BACKGROUND

• 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.

  PMID: 17448248 BACKGROUND

• 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.

  PMID: 24268570 BACKGROUND

• 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.

  PMID: 28851459 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Weight Loss

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Leigh A Dageforde, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 8, 2024
• Study Start: February 28, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 30, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)