IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial

NCT01869348 | Completed Results

• 1 other identifier: 13-071
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

As individuals age, their physical activity decreases and sedentary time increases. Even small changes in these two behaviors can greatly decrease risks for several major health problems, including cardiovascular disease, diabetes, and many cancers. Studies that use pedometers to encourage walking have successfully increased physical activity, but do not address sedentary behaviors such as television watching. The investigators propose to use a novel pedometer-like device (Jawbone Up) that encourages both increased physical activity and decreased sedentary time. First, the investigators will recruit 10 adults to participate in a brief intervention for six weeks. They will wear the wrist-based activity monitor and use a mini-tablet device to see feedback on their activity and sedentary time. They will also receive brief counseling weekly. The investigators will use this first study to investigate the basic feasibility of the intervention materials. Next, the investigators will recruit 20 adults and randomize them to receive the intervention for 12 weeks or to a waiting list. Here, the investigators will test the intervention with refinements made based on participant responses from the first small study. Our primary outcomes will be measures of feasibility and acceptability across all parts of the study. The investigators hypothesize that the intervention will be feasible and acceptable to the participants. The investigators will also measure physical activity, sedentary behavior, fitness, body fat, and psychological feelings of motivation.

Conditions

Obesity; Cardiovascular Disease; Cancer; Diabetes; Sarcopenia

Keywords

Physical activity; Activity monitor; Technology; Obesity; Aging muscle

Outcome Measures

Primary Outcomes (1)

• Change in Physical Activity From Baseline to 12 Weeks

  Minutes of physical activity measured over a seven day period

  12 weeks

Secondary Outcomes (6)

• Change in Sedentary Behavior From Baseline to 12 Weeks

  12 weeks

• Change in Autonomous Motivation From Baseline to 12 Weeks

  12 weeks

• Change in Physical Fitness From Baseline to 12 Weeks

  12 weeks

• Change in Body Composition From Baseline to 12 Weeks

  12 weeks

• Change in Physical Function From Baseline to 12 Weeks

  12 weeks

Other Outcomes (2)

• Feasibility

  12 weeks

• Acceptability

  12 weeks

Study Arms (2)

Wait list control

NO INTERVENTION

This group will receive no intervention until after data collection for the randomized trial is completed. Then, they will receive the monitor intervention.

Monitor intervention

EXPERIMENTAL

This arm will receive the monitor intervention, including provision of a wristband activity monitor and mini-tablet as well as weekly counseling phone calls

Behavioral: Monitor intervention

Interventions

Monitor intervention BEHAVIORAL

Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide "idle alerts" that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior.

Monitor intervention

Eligibility Criteria

• Age: 55 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Willing to be randomized to either group

You may not qualify if:

• Age below 55 or above 79
• Unable to read and understand English
• Unable to read words in standard applications on a mobile device 5 - 10" large
• Unable to find transportation to the study location
• Investigator overseeing initial fitness test does not approve participation in the study
• Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q, items 1 - 4). Reporting taking medicine for blood pressure on this questionnaire will require a doctor's note to participate.
• Unable to walk for exercise (self-report)
• Report current symptoms of alcohol or substance dependence
• Plans to move away from the Galveston-Houston area or to be out of town for more than 1 week during the study period
• Unwillingness to report drugs taken for comorbidities such as hypertension or diabetes
• Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
• Participant is active (60 minutes of moderate-vigorous intensity activity per week or more)
• Participant watches little television (120 minutes per day or less)
• BMI is under 25 kg/m2 or over 35 kg/m2
• Another member of the household is a participant or staff member on this trial

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77550, United States

Location

Related Publications (2)

• Lewis ZH, Swartz MC, Martinez E, Lyons EJ. Social Support Patterns of Middle-Aged and Older Adults Within a Physical Activity App: Secondary Mixed Method Analysis. JMIR Aging. 2019 Aug 23;2(2):e12496. doi: 10.2196/12496.

  PMID: 31518281 DERIVED

• Lyons EJ, Swartz MC, Lewis ZH, Martinez E, Jennings K. Feasibility and Acceptability of a Wearable Technology Physical Activity Intervention With Telephone Counseling for Mid-Aged and Older Adults: A Randomized Controlled Pilot Trial. JMIR Mhealth Uhealth. 2017 Mar 6;5(3):e28. doi: 10.2196/mhealth.6967.

  PMID: 28264796 DERIVED

MeSH Terms

Conditions

Obesity; Cardiovascular Diseases; Neoplasms; Diabetes Mellitus; Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Behavior

Results Point of Contact

• Title: Eloisa Martinez
• Organization: The University of Texas Medical Branch

esmartin@utmb.edu

4092669643

Study Officials

• Elizabeth J Lyons, PhD, MPH

  The University of Texas Medical Branch

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: June 5, 2013
• Study Start: June 1, 2014
• Primary Completion: April 15, 2016
• Study Completion: April 15, 2016
• Last Updated: October 4, 2017
• Results First Posted: October 4, 2017

Record last verified: 2015-05

Locations

US (1)