Feasibility Study on the Impact of Economic Incentives to Improve the Management of Type 2 Diabetes Mellitus
REDEEM-Pilot
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Jul 2016
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 31, 2016
CompletedFirst Posted
Study publicly available on registry
September 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedResults Posted
Study results publicly available
February 2, 2024
CompletedFebruary 2, 2024
January 1, 2022
7 months
August 31, 2016
January 4, 2022
May 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Glycated Hemoglobin
HbA1c change at 3 months from baseline
Baseline and 3 months
Secondary Outcomes (1)
Change in Weight
Baseline and 3 months
Study Arms (3)
Individual incentives - Arm 1
EXPERIMENTALThis arm receives diabetes education + goal setting + individual rewards
Mixed incentives (Altruism) - Arm 2
EXPERIMENTALThis arm receives diabetes education + goal setting + companion support + individual rewards
Mixed Incentives (Cooperation) - Arm 3
EXPERIMENTALThis arm receives diabetes education + goal setting + companion support + shared rewards
Interventions
Participants interact with a diabetes educator (DE), every two weeks.
Goals for weight loss and change in levels of HbA1c
Patient has a companion/team support partner to support achieving goals.
The cash reward is given to the patient with diabetes.
Patients with diabetes and their companion support will each receive 50% of the cash reward.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus
- Body mass index 25-39.9 kg/m2, irrespective of HbA1c status
- Able to give consent
You may not qualify if:
- 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
- Available and committed to supporting the participant in achieving their goals
- Able to provide consent
- Physical or mental condition that does not allow him to help the participant to achieve goals
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Nacional Arzobispo Loayza
Lima, Peru
Related Publications (2)
Pesantes MA, Del Valle A, Diez-Canseco F, Bernabe-Ortiz A, Portocarrero J, Trujillo A, Cornejo P, Manrique K, Miranda JJ. Family Support and Diabetes: Patient's Experiences From a Public Hospital in Peru. Qual Health Res. 2018 Oct;28(12):1871-1882. doi: 10.1177/1049732318784906. Epub 2018 Aug 1.
PMID: 30066604RESULTMiranda JJ, Lazo-Porras M, Bernabe-Ortiz A, Pesantes MA, Diez-Canseco F, Cornejo SDP, Trujillo AJ. The effect of individual and mixed rewards on diabetes management: A feasibility randomized controlled trial. Wellcome Open Res. 2019 Feb 5;3:139. doi: 10.12688/wellcomeopenres.14824.3. eCollection 2018.
PMID: 30662958DERIVED
Related Links
- REVISED A descriptive study of potential participant preferences for the design of an incentivised weight loss programme for people with type 2 diabetes mellitus attending a public hospital in Lima, Peru
- The effect of individual and mixed rewards on diabetes management: A feasibility randomized controlled trial
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. J Jaime Miranda
- Organization
- Universidad Peruana Cayetano Heredia
Study Officials
- PRINCIPAL INVESTIGATOR
Jaime Miranda, MD, PhD
Universidad Peruana Cayetano Heredia
- PRINCIPAL INVESTIGATOR
Antonio Trujillo, PhD
Johns Hopkins Bloomberg School of Public Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2016
First Posted
September 7, 2016
Study Start
July 1, 2016
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
February 2, 2024
Results First Posted
February 2, 2024
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, 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
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.