Applying a Stress Framework to Health Behavior Change: A Fitbit Study

NCT03119220 | Completed

• 2 other identifiers: 15138P30AG048785
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

The current study aims to counteract perceived stress-related barriers to implementation and maintenance of positive health behavior change (i.e., increasing physical activity), by providing an individually tailored and comprehensive informational support program. This translates into an intervention that, in addition to behavior monitoring (low informational support), will provide comprehensive informational support by combining advice and suggestions on how to achieve positive physical activity change with information on the health effects of such a change (high informational support). The latter will be achieved by providing information on general health benefits of increasing physical activity as well as on how physical activity change is linked to individual changes in health-relevant outcomes (i.e., mood and sleep quality changes). Specifically, it is hypothesized that:

• Higher chronic stress levels in general as well as stress perceived by the anticipated task of improving physical activity will be negatively associated with physical activity changes.
• Participants receiving informational support will show decreases in task-related stress.
• Furthermore, participants who receive comprehensive informational support will show larger physical activity improvements than participants who do not receive informational support.
• Initial stress will act as a moderator of the effects of informational support on physical activity, such that higher initial stress will reduce the positive effects of informational support. Importantly, the proposed intervention is specifically designed to support the subsequent development of an intervention program that is not only feasible, but easy to implement by individuals motivated to achieve a positive health behavior change. A key factor will be the insights gained into stress as a mechanism that counteracts implementation and maintenance of behavior change. This is especially important given the central role of stress in negative health outcomes associated with lack of physical activity, such as poor sleep, negative mood, and chronic low-grade inflammation.

Conditions

Adult Disease

Outcome Measures

Primary Outcomes (1)

• daily steps

  daily physical activity measured in steps taken

  12 weeks

Study Arms (2)

Low informational support

OTHER

After the first week, informational support will be manipulated by providing one group with information in the form of physical activity monitoring only.

Device: Fitbit One

high informational support

OTHER

The second group will additionally receive individualized information on how to change behavior by providing maps of a participant's neighborhood with distances depicted in steps, lists with age- and health-status appropriate suggestions as to how to increase numbers of steps, as well as medical information linking changes in physical activity to change in health outcomes; and information on health effects of behavior change by monitoring changes in sleep in conjunction with physical activity changes.

Device: Fitbit One

Interventions

Fitbit One DEVICE

Participants will receive a Fitbit device and a detailed user manual as well as diary materials to record daily steps taken, miles walked, and flight of stairs walked for a total of 12 weeks. An in-person follow-up meeting will be scheduled 7 days after the initial meeting to establish the baseline activity level of the participant and to determine the target number of daily steps for the subsequent 5 blocks of 2 weeks.

Low informational support; high informational support

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• residents of Waltham and surrounding communities
• between the ages of 50 and 70+
• English and non-English speaking participants
• individuals who are sedentary and/or dealing with health issues and have been unsuccessful in implementing behavior change \*\*We will ask participants three questions that will be rated on a 1 to 10 scale. They will be asked 1) how concerned they are about their current level of exercise, 2) how much pressure they feel to exercise more, and 3) how difficult it feels to overcome obstacles to exercise. To be eligible, participants must rate the first question at a 6 or higher and the three questions together at 15.

You may not qualify if:

• Participants who have been told not to participate in physical activity or who have doubts about their ability to safely increase physical activity
• not able to walk or not able to walk continuously for several minutes without pain
• being very active and rate the question regarding how much they are in motion during the day at 8 or higher (on a scale of 1-10)

Sponsors & Collaborators

• Brandeis University: lead
• National Institute on Aging (NIA): collaborator

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The overall behavior change goal is defined as increasing physical activity by 15% every other week over 10 weeks based on an initial one week of activity recording establishing an individual's baseline. This will result in a doubling of the initial steps by weeks 10-11, while keeping the demands and goals comparable between individuals. After the first week, informational support will be manipulated by providing one group with information in the form of physical activity monitoring only. The second group will additionally receive individualized information on how to change behavior by providing maps of a participant's neighborhood with distances depicted in steps, lists with age- and health-status appropriate suggestions as to how to increase numbers of steps, as well as medical information linking changes in physical activity to change in health outcomes; and information on health effects of behavior change by monitoring changes in sleep in conjunction with physical activity changes.

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 18, 2017
• Study Start: May 8, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share