N/A
N=90
Feasibility Study on the Impact of Economic Incentives to Improve the Management of Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02891382 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Change in Glycated Hemoglobin — 1.4; 0.9; 1.1 "Percentage of glycated hemoglobin"
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diabetes education (Behavioral); Goal setting (Behavioral); Companion Support (Behavioral); Individual Reward (Behavioral); Shared Reward (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidad Peruana Cayetano Heredia
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycated Hemoglobin |
1.4; 0.9; 1.1 | — |
| SECONDARY Change in Weight |
2.9; 0.4; 0.4 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02891382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.