NCT02736903

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

6 months

First QC Date

April 4, 2016

Last Update Submit

January 10, 2018

Conditions

Sedentary Lifestyle

Outcome Measures

Primary Outcomes (1)

  • Daily active exercise minutes

    Daily active exercise minutes are recorded by the Fitbit (zip) tracking device

    Intervention day 1 to day 90

Secondary Outcomes (3)

  • Daily steps

    Intervention day 1 to day 90

  • Daily active calories

    Intervention day 1 to day 90

  • Self-reported physical activity

    Past 7 days

Study Arms (2)

Individual intervention

ACTIVE COMPARATOR

Behavioral: PennFit mobile individual intervention. Participants were given a Fitbit (zip) to track their daily exercises. Participants used the PennFit app to track their own daily steps and the minutes for vigorous, moderate, and muscle-strengthening exercises that they completed for each day. Participants also received system-generated notifications that reminded them to wear their Fitbit in the morning and to log their activity minutes in the evening.

Behavioral: PennFit mobile individual intervention

Online network intervention

EXPERIMENTAL

Behavioral: PennFit mobile online network intervention. Participants were given a Fitbit (zip) to track their daily exercises. Participants used the PennFit app to track their exercises. Participants also received system-generated notifications that reminded them to wear their Fitbit in the morning and to log their activity minutes in the evening. Participants were randomly assigned to 4-person online networks in the PennFit app. Participants in the online networks could see both their own information and the profiles and activity logs of the three other people assigned to their network. In addition, they could send messages to the network through an instant chatting tool.

Behavioral: PennFit mobile online network intervention

Interventions

PennFit mobile individual interventionBEHAVIORAL

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.

Individual intervention
PennFit mobile online network interventionBEHAVIORAL

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.

Online network intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • African American women (self-identified)
  • Aged 18 to 35
  • Using an Android smartphone
  • Residing in Philadelphia

You may not qualify if:

  • Already participating in another physical activity study
  • Not able or willing to carry an Android smartphone
  • Being pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 26844132BACKGROUND

  • 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.

    PMID: 24736094BACKGROUND

  • Zhang J, Jemmott Iii JB. Mobile App-Based Small-Group Physical Activity Intervention for Young African American Women: a Pilot Randomized Controlled Trial. Prev Sci. 2019 Aug;20(6):863-872. doi: 10.1007/s11121-019-01006-4.

    PMID: 30788692DERIVED

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • John B Jemmott, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 13, 2016

Study Start

December 1, 2015

Primary Completion

May 30, 2016

Study Completion

September 30, 2017

Last Updated

January 12, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share