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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02891382 |
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Date of registration:
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31/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Feasibility Study on the Impact of Economic Incentives to Improve the Management of Type 2 Diabetes Mellitus
REDEEM-Pilot |
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Scientific title:
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Feasibility Study on the Impact of Economic Incentives for Weight Loss to Improve the Management of Type 2 Diabetes Mellitus: REDEEM Feasibility Study |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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54 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02891382 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
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Phase:
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N/A
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Countries of recruitment
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Peru
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Contacts
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Name:
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Antonio Trujillo, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Johns Hopkins Bloomberg School of Public Health |
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Name:
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Jaime Miranda, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad Peruana Cayetano Heredia |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Intervention(s)
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Behavioral: Individual Reward
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Behavioral: Companion Support
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Behavioral: Diabetes education
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Behavioral: Shared Reward
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Behavioral: Goal setting
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Primary Outcome(s)
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Glycated hemoglobin
[Time Frame: 3 months]
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Secondary Outcome(s)
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Weight loss
[Time Frame: 3 months]
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Secondary ID(s)
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MR/M007405/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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