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Trial record 67 of 1403 for:    Peru

Feasibility Study on the Impact of Economic Incentives to Improve the Management of Type 2 Diabetes Mellitus (REDEEM-Pilot)

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ClinicalTrials.gov Identifier: NCT02891382
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : January 19, 2018
Sponsor:
Collaborator:
Johns Hopkins Bloomberg School of Public Health
Information provided by (Responsible Party):
Universidad Peruana Cayetano Heredia

Brief Summary:

This feasibility study aims to compare the implementation process of three different interventions that use economic incentives to promote lifestyle behavioral changes in patients with type 2 diabetes mellitus, and to identify barriers and facilitators linked to the process of implementing each of the interventions. The interventions are based on economic incentives directed to the patient (individual incentives) or a team comprised by the patient and a partner (mixed incentives).

Design: Three-month randomized control feasibility study to test the feasibility of implementing three types of intervention with economic incentives in patients with diabetes mellitus.

Setting: Diabetes outpatient clinics from a public hospital in Peru.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Diabetes education Behavioral: Goal setting Behavioral: Companion Support Behavioral: Individual Reward Behavioral: Shared Reward Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Feasibility Study on the Impact of Economic Incentives for Weight Loss to Improve the Management of Type 2 Diabetes Mellitus: REDEEM Feasibility Study
Study Start Date : July 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arm Intervention/treatment
Experimental: Individual incentives - Arm 1
This arm receives diabetes education + goal setting + individual rewards
Behavioral: Diabetes education
Participants interact with a diabetes educator (DE), every two weeks.

Behavioral: Goal setting
Goals for weight loss and change in levels of HbA1c

Behavioral: Individual Reward
The cash reward is given to the patient with diabetes.

Experimental: Mixed incentives (Altruism) - Arm 2
This arm receives diabetes education + goal setting + companion support + individual rewards
Behavioral: Diabetes education
Participants interact with a diabetes educator (DE), every two weeks.

Behavioral: Goal setting
Goals for weight loss and change in levels of HbA1c

Behavioral: Companion Support
Patient has a companion/team support partner to support achieving goals.

Behavioral: Individual Reward
The cash reward is given to the patient with diabetes.

Experimental: Mixed Incentives (Cooperation) - Arm 3
This arm receives diabetes education + goal setting + companion support + shared rewards
Behavioral: Diabetes education
Participants interact with a diabetes educator (DE), every two weeks.

Behavioral: Goal setting
Goals for weight loss and change in levels of HbA1c

Behavioral: Companion Support
Patient has a companion/team support partner to support achieving goals.

Behavioral: Shared Reward
Patients with diabetes and their companion support will each receive 50% of the cash reward.




Primary Outcome Measures :
  1. Glycated hemoglobin [ Time Frame: 3 months ]
    HbA1c change at 3 months from baseline


Secondary Outcome Measures :
  1. Weight loss [ Time Frame: 3 months ]
    Weight and BMI change at 3 months from baseline


Other Outcome Measures:
  1. Feasibility [ Time Frame: 3 months ]
    Feasibility of conducting a three-arm incentives-based pilot study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for participants:

  • Type 2 diabetes mellitus
  • Body mass index 25-39.9 kg/m2, irrespective of HbA1c status
  • Able to give consent

Exclusion Criteria for participants:

  • Diagnosis of cancer or another serious comorbidity
  • Pharmacotherapy for weight loss or corticosteroids
  • Pregnant women
  • Blindness, amputation, foot ulcer or being on dialysis
  • Be companion/team support for another participant in the trial

Inclusion criteria for the companion/team support:

  • Available and committed to supporting the participant in achieving their goals
  • Able to provide consent

Exclusion criteria for the companion/team support:

  • Physical or mental condition that does not allow him to help the participant to achieve goals

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891382


Locations
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Peru
Hospital Nacional Arzobispo Loayza
Lima, Peru
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Johns Hopkins Bloomberg School of Public Health
Investigators
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Principal Investigator: Jaime Miranda, MD, PhD Universidad Peruana Cayetano Heredia
Principal Investigator: Antonio Trujillo, PhD Johns Hopkins Bloomberg School of Public Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT02891382     History of Changes
Other Study ID Numbers: MR/M007405/1
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Following on MRC's data sharing policy, we plan to make our quantitative datasets available in platforms for data sharing (e.g. Figshare, etc.). Qualitative data will be available upon request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Analytic Code
Time Frame: The dataset with quantitative information will be available within six months from the publication of the main manuscript.
Access Criteria: Contact cronicas@oficinas-upch.pe; maria.pesantes.v@upch.pe; maria.lazo@upch.pe; and/or jaime.miranda@upch.pe
URL: https://www.mrc.ac.uk/research/policies-and-guidance-for-researchers/data-sharing/
Keywords provided by Universidad Peruana Cayetano Heredia:
Diabetes Mellitus, Type 2
Weight Loss
Financial Incentives
Hemoglobin A, Glycosylated
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases