UMIN-CTR Clinical Trial

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

No diseases

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Physical activity

Key secondary outcomes

Social capital, Age, Body height, Body weight, Body mass index, Percentage of body fat

Study type

Interventional

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

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

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

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

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

Institute

Kumamoto Institute of Total Fitness

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Osaka sangyo univercity

Name of secondary funder(s)

Organization

Kumamoto Kinoh Hospital

Address

6-8-1 Yamamuro, Kita-ku, Kumamoto

Tel

096-345-8111

Email

mcjhealth@juryo.or.jp

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

熊本健康・体力づくりセンター

Date of disclosure of the study information

2019

Year

10

Month

01

Day

URL releasing protocol

We presented the results of this study at ACSM. We are submmiting manuscriots to journals.

Publication of results

Unpublished

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

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 related information

Registered date

2019

Year

09

Month

22

Day

Last modified on

2019

Year

09

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043392