UMIN-CTR Clinical Trial

Public title

Exploratory study of motivational methods leading to habituation of exercise: "Walking for health, where each step taken helps to protect the lives and futures of children around the world"

Acronym

Effectiveness of charitable donations as a motivator for habituation of exercise

Scientific Title

Exploratory study of motivational methods leading to habituation of exercise: "Walking for health, where each step taken helps to protect the lives and futures of children around the world"-a randomized controlled trial to examine the effectiveness of charitable donations as a motivator for habituation of exercise

Scientific Title:Acronym

Exploratory study of the effectiveness of charitable donations as a motivator for regular physical activity

Region

Japan

Condition

Workers (university faculty and staff) with low daily levels of walking (number of steps) who desire to increase the amount they walk

Classification by specialty

Endocrinology and Metabolism	Orthopedics	Rehabilitation medicine
Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine the effectiveness of charitable donations as a motivator for regular physical activity.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. Increase in average number of steps walked per day compared with baseline (pre-intervention two-month average).
2. Degree of achievement of step targets.
(Measured at 3 time points: immediately after, 3 months after, and 1 year after completion of intervention)

Key secondary outcomes

A)Physical findings:
-Height
-Weight
-Blood pressure
-Waist circumference
-Visceral fat mass(dual scan)

B) Blood findings:
-Biochemical tests (AST, ALT, LDL-C, HDL-C, Triglyceride, uric acid)
-fasting blood glucose
-Hormonal tests (Leptin, corticotropin, cortisol, testosterone, insulin-like growth factor 1, fasting insulin, Amylin, C-Peptide, Ghrelin, GIP, Glucagon, MCP-1/CCL2, Pancreatic Polypeptide(PP), PYY, TNFa)
-Myokines (Apelin, BDNF, EPO, FABP-3, FGF-21, Fractalkine/CX3CL1, Follistatin-like Protein 1 (FSTL-1), IL-6, IL-15, Irisin, Leukemia Inhibitory Factor(LIF), Myostatin/GDF8, Oncostatin M(OSM), Osteocrin/Musclin, Osteonectin, SPARC)
-Adipokines (Adiponectin, Adipsin/Factor D, NGAL/Lipocalin-2, PAI-1, Resistin)
-Hormones and cytokines related to aging (CTACK/CCL27, GDF-11, GDF-15, GnRH, IL-10, IL-18, Jag1, Wnt-3a)

C) Mental health screening:
-Stress check (63 items, comprised of the 57-item Simple Occupational Stress Questionnaire and the 6-item K6 scale that measures psychological distress)
-Temperament and Character Inventory (TCI)
-Subjective happiness survey
-Degree of self-efficacy/self-affirmation (General Self-Efficacy Scale)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

YES

Concealment

Pseudo-randomization

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention group (charitable donationgroup)
Intervention consists of donations to the Japan Committee for UNICEF; donations are calculated based on the amount of increase in average number of steps walked per day during the 3-month intervention period, compared with baseline walking levels (pre-intervention two-month average).

1) If the increase in the daily average number of steps walked during the intervention period is at least 1 step/day above the baseline walking level, 1 Japanese yen is donated for each step over the average.

2) If the average number of steps walked during the intervention period is 9,000 steps/day (males), or 8,500 steps/day (females), 1,000 Japanese yen is donated.

Universal interventions:
i.Setting of step targets
ii.Self-monitoring of steps
iii.Twice-monthly notice (e-mail) from the health center to encourage increases in steps taken, and to inform participants of their average number of steps.

Interventions/Control_2

Control group (waitlist control)
Only the following interventions will be performed:
i.Setting of step targets
ii.Self-monitoring of steps
iii.Twice-monthly notice (e-mail) from the health center to encourage increases in steps taken, and to inform participants of their average number of steps.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

-Nagasaki University employees (faculty and staff, including part-time staff) who desire to increase the number of steps walked.
-Men and women aged 20 to 65 (participation by people up to 70 years old will be considered on an individual basis, upon request).
-Average number of steps per day fewer than 9,000 (men) or 8,500 (women).
-Individuals who are able to download the specified step-counting application to their smartphone and track the number of steps they take.
-Individuals who consent to participate in the study.

Key exclusion criteria

-Employees who have difficulty walking.
-Those people who, in a preliminary survey, are already walking more than the average daily step target (9,000 steps for men; 8,500 steps for women) established by the Ministry of Health, Labor and Welfare.

Target sample size

60

Name of lead principal investigator

1st name	Ikuko
Middle name
Last name	Sagara

Organization

Nagasaki University

Division name

Center for Health and Community Medicine

Zip code

852-8521

Address

1-14, Bunkyo-machi, Nagasaki, Japan

TEL

0958192214

Email

ueki-fko@umin.ac.jp

Name of contact person

1st name	Ikuko
Middle name
Last name	Sagara

Organization

Nagasaki University

Division name

Center for Health and Community Medicine

Zip code

852-8521

Address

1-14, Bunkyo-machi, Nagasaki, Japan

TEL

095-819-2214

Homepage URL

http://www.hc.nagasaki-u.ac.jp/healthbank/index

Email

ueki-fko@umin.ac.jp

Institute

Center for Health and Community Medicine Nagasaki University

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Meiji Yasuda Life Foundation of Health and Welfare

Organization

Graduate School of Biomedical Sciences, Health Science Courses, Ethics Committee.

Address

1-12-4, Sakamoto, Nagasaki, Japan

Tel

095-819-7198

Email

gakujutu_gakuji@ml.nagasaki-u.ac.jp

Secondary IDs

NO

Study ID_1

180507472

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

長崎大学保健・医療推進センター

Date of disclosure of the study information

2019

Year

10

Month

31

Day

URL releasing protocol

http://www.hc.nagasaki-u.ac.jp/healthbank/index

Publication of results

Partially published

URL related to results and publications

http://www.hc.nagasaki-u.ac.jp/healthbank/index

Number of participants that the trial has enrolled

54

Results

Results date posted

Results Delayed

Delay expected

Results Delay Reason

Because we were unable to collect data due to the corona crisis.

Date of the first journal publication of results

2020

Year

04

Month

30

Day

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2018

Year

04

Month

01

Day

Date of IRB

2018

Year

05

Month

17

Day

Anticipated trial start date

2019

Year

04

Month

26

Day

Last follow-up date

2020

Year

08

Month

31

Day

Date of closure to data entry

2021

Year

05

Month

31

Day

Date trial data considered complete

2021

Year

05

Month

31

Day

Date analysis concluded

2022

Year

03

Month

31

Day

Other related information

URL
http://www.hc.nagasaki-u.ac.jp/healthbank/index

Registered date

2019

Year

10

Month

31

Day

Last modified on

2022

Year

11

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043766