Behavioural Economics-based Incentives in Adults With Type 2 Diabetes Pilot Study
17. maj 2022 opdateret af: The University of Hong Kong
Effectiveness of Behavioural Economics-based Incentives on Glycaemic Control and Lifestyle in Adults With Newly Diagnosed Type 2 Diabetes: a Feasibility Pilot Study
A feasibility pilot study of a randomised control trial of adults newly diagnosed with type 2 diabetes to compare the effectiveness of financial and social incentives on healthy lifestyle behaviour.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a pilot study of testing the feasibility of the interventions being implemented in our main trial in local settings.
Adults newly diagnosed with type 2 diabetes without receiving any anti-diabetic medication in Hong Kong are randomised to compare the effectiveness of financial and social incentives against a control group receiving standard care.
The investigators follow participants for 9-months (6-month intervention period and a 3-month post-intervention follow-up period) to assess glycemic control and other health indicators.
Participants will be randomly assigned to one of two groups (in ratio 3:1): arm A (financial and social incentives in addition to standard care), and arm B (control arm receiving standard care).
Financial incentives will be framed around loss aversion and the endowment effect.
Social incentives will include peer competition, and social support.
Financial and social incentives are to encourage increased physical activity and participants will use a pedometer to track activity.
Participants are followed for an additional 3-months after the cessation of incentives to assess the sustainability of lifestyle changes.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
11
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Hong Kong, Hong Kong
- School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
30 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Chinese adults aged 30-70 years
- Capable of providing informed consent
- Resident in Hong Kong
- Able to communicate in English or Chinese
- Newly diagnosed with type 2 diabetes within a year according to World Health Organization guidelines: HbA1c ≥ 48 mmol/mol (≥ 6.5%); fasting plasma glucose ≥ 7.0 mmol/l (≥ 126 mg/dl); oral glucose tolerance test (OGTT) ≥ 11.1 mmol/l (200 mg/dl) with symptoms, or on two separate occasions if asymptomatic
- HbA1c ≤ 7.5%
- Not taking any medication for glycaemic control
- Willing to take blood tests
- Access to a smart phone to track physical activity
- Physically mobile for duration of the trial
Exclusion Criteria:
- Already participating in another intervention study
- Any health condition prohibiting them from completing the 9-month trial, such as history of eating disorder, cancer, serious illness, breastfeeding
- Medical conditions that can affect HbA1c measurements including anaemia, haemoglobinopathies, haemodialysis, iron/B12 deficiency or supplements, chronic liver diseases, splenectomy, rheumatoid arthritis, use of anti-retroviral drugs, ribavirin, or aspirin
- Intend to receive medication for glycaemic control in the next 6 months
- Intend to seek private medical treatment for diabetes in the next 6 months
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Styring
Deltagerne vil modtage standardbehandling, herunder patientscreening og undervisning i kost, fysisk aktivitet og rygning udført af et tværfagligt team.
Deltagerne i kontrolgruppen vil hverken få at vide om deres baseline-skridttælling eller modtage feedback-beskeder.
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Eksperimentel: Intervention
Participants will receive the usual standard care (same as control group), loss-framed financial incentive, social incentives and weekly feedback on performance for 6 months.
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Participants will be credited with HK$1000 in their virtual accounts at the beginning of the trial. After baseline step counts are gathered in the second week, participants will lose HK$40 for each subsequent week that they do not meet their personal weekly step target. The social incentives are peer comparison and social support. Participants receive feedback of their physical activity performance by assessing whether they met or exceeded their step count target, followed by positive messages for encouragement. Nominated supporters will be informed of participants' performance for social support. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Glycemic control
Tidsramme: Baseline, 6 and 9 months
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Change in HbA1c levels
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Baseline, 6 and 9 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in physical activity (step count)
Tidsramme: Baseline, 6 and 9 months
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Step counts
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Baseline, 6 and 9 months
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Change in body weight
Tidsramme: Baseline, 6 and 9 months
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kg
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Baseline, 6 and 9 months
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Changes in lipid profile
Tidsramme: Baseline, 6 and 9 months
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Total, HDL- and LDL-cholesterol; Triglycerides
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Baseline, 6 and 9 months
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Change in physical activity level
Tidsramme: Baseline, 6 and 9 months
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International Physical Activity Questionnaires (IPAQ)
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Baseline, 6 and 9 months
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in health service utilisation
Tidsramme: Baseline, 6 and 9 months
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Number of attendances and hospital admission
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Baseline, 6 and 9 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Jianchao Quan, MPH, BM BCh, School of Public Health, The University of Hong Kong
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. november 2020
Primær færdiggørelse (Faktiske)
6. september 2021
Studieafslutning (Faktiske)
7. december 2021
Datoer for studieregistrering
Først indsendt
17. juni 2020
Først indsendt, der opfyldte QC-kriterier
21. juni 2020
Først opslået (Faktiske)
23. juni 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. maj 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. maj 2022
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BET2-v2-202005
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Information will shared in accordance with the University of Hong Kong Data Management Plan (DMP)
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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