NCT02531763

Brief Summary

BE FIT (Behavioral Economics Framingham Incentive Trial) is a pilot study to test the deployment of a social incentive intervention using the Framingham Heart Study (FHS) Offspring, Generation 3, and Omni cohorts to increase physical activity (PA). The investigators will leverage the strength of FHS by recruiting trios and nuclear families to test whether social connectedness increases PA. The investigators will utilize a randomized controlled trial design. The investigators will test a social incentive intervention strategy using a team-based design in which participants work together to jointly achieve their PA goals, and a social connectedness intervention.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

8 months

First QC Date

August 19, 2015

Last Update Submit

August 29, 2016

Conditions

Keywords

mHealthbehavioral economicssocial incentives

Outcome Measures

Primary Outcomes (1)

  • proportion of days achieving their step goals over intervention period.

    12 weeks

Secondary Outcomes (2)

  • Mean daily steps adjusted for baseline step count

    Weeks 1 to 12, and weeks 13 to 24

  • Proportion participant-days achieving step goals

    Weeks 13 to 24

Study Arms (2)

Control

NO INTERVENTION

FHS participants who enrolled with family member will not receive the social incentive intervention and will participate individually but will set a daily step goal and receive daily feedback on whether he or she achieved the goal or not.

Intervention

ACTIVE COMPARATOR

FHS participants who enrolled with a family member will be placed on a team as connected individuals (both in the same family) who will set a daily step goal, receive daily feedback on whether they achieved their goal, and receive the social incentive intervention.

Behavioral: Social incentive intervention

Interventions

Participant sign a pre-commitment pledge to try to achieve their goal. They are entered into a game with their teammate in which they have the chance to earn points and advance through levels (bronze, silver, gold, platinum). At the end, those in gold or platinum will receive a coffee mug as a reward

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • FHS study members from any of the existing cohorts (Offspring, Gen 3, Omni groups 1)
  • Must have active email address
  • Must have participated in the FHS Digital Connectedness Survey
  • Must have at least 2 family members in the FHS

You may not qualify if:

  • Not currently participating in any other physical activity studies.
  • Not told by a physician not to exercise.
  • Not currently pregnant.
  • Not had at least one fall with significant injury in the past year.
  • Not had any surgical procedures in the participants' legs that would prohibit physical activity.
  • Not have any other medical conditions or other reasons to prevent participation in a 6 month physical activity program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Patel MS, Benjamin EJ, Volpp KG, Fox CS, Small DS, Massaro JM, Lee JJ, Hilbert V, Valentino M, Taylor DH, Manders ES, Mutalik K, Zhu J, Wang W, Murabito JM. Effect of a Game-Based Intervention Designed to Enhance Social Incentives to Increase Physical Activity Among Families: The BE FIT Randomized Clinical Trial. JAMA Intern Med. 2017 Nov 1;177(11):1586-1593. doi: 10.1001/jamainternmed.2017.3458.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Caroline S Fox, MD MPH

    National Heart, Lung, and Blood Institute (NHLBI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2015

First Posted

August 24, 2015

Study Start

September 1, 2015

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08