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Behavioral Economics Framingham Incentive Trial (BE FIT) (BEFIT)

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ClinicalTrials.gov Identifier: NCT02531763
Recruitment Status : Completed
First Posted : August 24, 2015
Last Update Posted : August 30, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Physical Activity Behavioral: Social incentive intervention

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Behavioral Economics Framingham Incentive Trial: A Randomized Controlled Trial
Study Start Date : September 2015
Primary Completion Date : May 2016
Study Completion Date : August 2016
Arms and Interventions

Arm Intervention/treatment
No Intervention: Control
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.
Active Comparator: Intervention
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
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


Outcome Measures

Primary Outcome Measures :
  1. proportion of days achieving their step goals over intervention period. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Mean daily steps adjusted for baseline step count [ Time Frame: Weeks 1 to 12, and weeks 13 to 24 ]
  2. Proportion participant-days achieving step goals [ Time Frame: Weeks 13 to 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531763


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Boston University
University of Pennsylvania
Investigators
Principal Investigator: Caroline S Fox, MD MPH National Heart, Lung, and Blood Institute (NHLBI)
More Information

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT02531763     History of Changes
Other Study ID Numbers: 1ZIAHL006094-05 ( U.S. NIH Grant/Contract )
HHSN268201500056P ( Other Identifier: NHLBI )
First Posted: August 24, 2015    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
mHealth
behavioral economics
social incentives