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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02736903
Other study ID # 823881
Secondary ID
Status Completed
Phase N/A
First received April 4, 2016
Last updated January 10, 2018
Start date December 2015
Est. completion date September 30, 2017

Study information

Verified date January 2018
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Despite the racial disparities in rates of chronic diseases and behaviors linked to chronic diseases, there have been relatively few RCTs of interventions to increase physical activity in African American women. Although some studies found significant improvement on physical activity, most focused on individuals and did not take into consideration the social contexts in which the participants' behaviors occurred. Understanding how online social networks facilitate behavior change can bridge important gaps in the way technology can be used to intervene on health among underserved populations. The primary objective of this study was to test the efficacy of a mobile app (PennFit) intervention in increasing participants' daily active minutes objectively recorded by a fitness tracking device (Fitbit zip). In the control group, participants used the PennFit app to record and monitor their own physical activity progress. In the online social network intervention, participants were randomized to 4-women networks and were able to see and compare their own recorded physical activities with activities of the other three women in their network. Participants in a network had access to an online chatting tool to chat with one another. The secondary objective was to understand the intervention's mechanisms through mediation analysis on theoretical variables.


Description:

Despite the racial disparities in rates of chronic diseases and behaviors linked to chronic diseases, there have been relatively few RCTs of interventions to increase physical activity in African American women. Although some studies found significant improvement on physical activity, most focused on individuals and did not take into consideration the social contexts in which the participants' behaviors occurred. A review of qualitative studies of physical-activity correlates in African American adults found that both men and women said group participation would increase their motivation to exercise, and women said that having a physically active partner or friend would facilitate their initiation and maintenance of a physical-activity program. For instance, focus groups with African American women suggested that having a friend or group to exercise with was motivating and should be considered to be an important component of physical activity programs.This finding is consistent with other studies identifying social support as encouraging African American women to engage in physical activity. While previous research emphasized the effects of social support on facilitating physical activity, it is also possible that a lack of social network members perceiving physical activity as a normative behavior may contribute to low rates of physical activity in African American women. Two correlational research found that social support and descriptive norms both predicted physical activity independently . Two experiments found that manipulating descriptive norms increased physical activity . The findings suggest creating physical activity as a normative behavior within African American women's social networks may be an effective way to establish, potentially sustaining physical activity in the long term.

Young African Americans are heavy users of social networking technologies. In 2013, 96% of African Americans aged 18 to 29 used a social networking site of some kind. Understanding how online social networks facilitate behavior change can bridge important gaps in the way technology can be used to intervene on health among underserved populations. The primary objective of this study was to test the efficacy of a mobile app (PennFit) intervention in increasing participants' daily active minutes objectively recorded by a fitness tracking device (Fitbit zip). In the control group, participants used the PennFit app to record and monitor their own physical activity progress. In the online social network intervention, participants were randomized to 4-women networks and were able to see and compare their own recorded physical activities with activities of the other three women in their network. Participants in a network had access to an online chatting tool to chat with one another. The secondary objective was to understand the intervention's mechanisms through mediation analysis on theoretical variables.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date September 30, 2017
Est. primary completion date May 30, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- African American women (self-identified)

- Aged 18 to 35

- Using an Android smartphone

- Residing in Philadelphia

Exclusion Criteria:

- Already participating in another physical activity study

- Not able or willing to carry an Android smartphone

- Being pregnant

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
PennFit mobile individual intervention
PennFit (individual) is a mobile app intervention. Participants received a Fitbit physical activity tracking device and an introductory physical activity promotion session emphasizing the health benefits of physical activity and building skills for daily exercises. Participants used the PennFit app (individual) to record and monitor their own physical activity progress.
PennFit mobile online network intervention
PennFit (online network) is a mobile app intervention. Participants received a Fitbit physical activity tracking device and an introductory physical activity promotion session emphasizing the health benefits of physical activity and building skills for daily exercises. Participants used the PennFit app (online network) to record and monitor their own physical activity progress. They could see both their own information and the profiles and activity logs of the three other women assigned to their network. In addition, they could send messages to the network through an instant chatting tool.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

References & Publications (2)

Jemmott JB 3rd, Jemmott LS, Ngwane Z, Zhang J, Heeren GA, Icard LD, O'Leary A, Mtose X, Teitelman A, Carty C. Theory-based behavioral intervention increases self-reported physical activity in South African men: a cluster-randomized controlled trial. Prev Med. 2014 Jul;64:114-20. doi: 10.1016/j.ypmed.2014.04.012. Epub 2014 Apr 13. — View Citation

Zhang J, Brackbill D, Yang S, Centola D. Efficacy and causal mechanism of an online social media intervention to increase physical activity: Results of a randomized controlled trial. Prev Med Rep. 2015 Aug 13;2:651-7. doi: 10.1016/j.pmedr.2015.08.005. eCollection 2015. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Daily active exercise minutes Daily active exercise minutes are recorded by the Fitbit (zip) tracking device Intervention day 1 to day 90
Secondary Daily steps Daily steps are recorded by the Fitbit (zip) tracking device Intervention day 1 to day 90
Secondary Daily active calories Daily active calories are recorded by the Fitbit (zip) tracking device Intervention day 1 to day 90
Secondary Self-reported physical activity The number of days on which participants reported engaging in 20 minutes of vigorous-intensity activity, 30 minutes of moderate-intensity activity, and strength-building activity, in the past 7 days. Past 7 days
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