UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000038080
Receipt No. R000043392
Scientific Title Effects of social network incentives and financial incentives on physical activity and social capital among elderly women: a randomized controlled trial
Date of disclosure of the study information 2019/10/01
Last modified on 2019/09/22 (Ver. 1)

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Basic information
Public title Effects of social network incentives and financial incentives on physical activity and social capital among elderly women: a randomized controlled trial
Acronym SNI walking in Kumamoto study
Scientific Title Effects of social network incentives and financial incentives on physical activity and social capital among elderly women: a randomized controlled trial
Scientific Title:Acronym SNI walking in Kumamoto study
Region
Japan

Condition
Condition No diseases
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The main goal of this study was to ascertain whether combining financial incentives with social network incentives could lead to more significant changes in physical activity and social capital among elderly women, compared to financial incentives alone, during and after the intervention.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Physical activity
Key secondary outcomes Social capital, Age, Body height, Body weight, Body mass index, Percentage of body fat

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 The financial incentive group (FI group) underwent a three-month intervention. Measurements of physical activity and social capital was performed before and after the intervention. Additionally, the effects of incentives on physical activity and social capital maintenance was measured six months post-intervention. FI group received a payment ranging from US$4.40 to US$6.20 per month depending on the number of steps taken during the intervention.
Interventions/Control_2 The social network incentive plus financial incentive group (SNI+FI group) underwent a three-month intervention. Measurements of physical activity and social capital was performed before and after the intervention. Additionally, the effects of incentives on physical activity and social capital maintenance was measured six months post-intervention. In SNI+FI group, we provided a social network incentive in addition to the financial incentive (US$4.40-US$6.20 per month). The SNI+FI group walked in three people to use the power of peer pressure. The participants was informed that they would walk in groups of three people about once a week. Furthermore, their rewards was designed to reflect the largest number of steps taken among buddies.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit
90 years-old >
Gender Female
Key inclusion criteria Elderly women over 65 years of age
Key exclusion criteria Women who have difficulty walking
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Ryo
Middle name
Last name Yamashita
Organization Kumamoto Institute of Total Fitness
Division name Department of Health Science
Zip code 860-8518
Address 6-8-1 Yamamuro, Kita-ku, Kumamoto
TEL 096-345-8113
Email ryo513@hotmail.co.jp

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Yamashita
Organization Kumamoto Institute of Total Fitness
Division name Department of Health Science
Zip code 860-8518
Address 6-8-1 Yamamuro, Kita-ku, Kumamoto
TEL 096-345-8113
Homepage URL
Email ryo513@hotmail.co.jp

Sponsor
Institute Kumamoto Institute of Total Fitness
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka sangyo univercity
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kumamoto Kinoh Hospital
Address 6-8-1 Yamamuro, Kita-ku, Kumamoto
Tel 096-345-8111
Email mcjhealth@juryo.or.jp

Secondary IDs
Secondary IDs YES
Study ID_1 2017-JINRIN-016
Org. issuing International ID_1 Osaka sangyo univercity
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 熊本健康・体力づくりセンター

Other administrative information
Date of disclosure of the study information
2019 Year 10 Month 01 Day

Related information
URL releasing protocol We presented the results of this study at ACSM. We are submmiting manuscriots to journals.
Publication of results Unpublished

Result
URL related to results and publications We presented the results of this study at ACSM. We are submmiting manuscriots to journals.
Number of participants that the trial has enrolled 39
Results 
There was a statistically significant interaction between group and time. The SNI+FI group increased significantly between the pre-intervention and the six-month post-intervention periods. However, the FI group showed no statistically significant improvement in physical activity during the observation period. In social capital, trust was close to significance. The SNI+FI group increased close to significantly between the pre-intervention and the three month, and the six-month post-intervention periods.
Results date posted
2019 Year 09 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
All: age average 71.9 (SD 5.7) years, BMI average 22.2 (SD 2.8), percentage of body fat average 37.3 (SD 4.0) %, FI group: age average 70.6 (SD 4.9) years, BMI average 22.6 (SD 2.4), percentage of body fat average 37.5 (SD 2.7)%, SNI+FIgroup: age average 73.5 (SD 6.3) years, BMI average 21.8 (SD 3.2), percentage of body fat average 37.1 (SD5.3)%.
Participant flow 
A participants of this study were recruited by handing out leaflets in several different regions in Kumamoto, Japan. Forty-four elderly women over 65 years of age were recruited between August 2017 and September 2017. Before starting the study, the participants were divided randomly into a financial incentive group (FI group) and an FI plus social network incentive group (SNI+FI group). The grouping methods was confidential to the participants. During the intervention, two participants in the FI group and three in the SNI+FI group dropped out. Eventually, the study groups comprised 21 participants in the FI group and 18 participants in the SNI+FI group.
Adverse events 
There were no adverse events.
Outcome measures 
Physical activity, Social capital, Age, Body height, Body weight, Body mass index, Percentage of body fat.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 08 Month 03 Day
Date of IRB
2017 Year 08 Month 03 Day
Anticipated trial start date
2017 Year 08 Month 07 Day
Last follow-up date
2017 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 09 Month 22 Day
Last modified on
2019 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043392