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. 2021 Jun 25;2021(6):CD012784. doi: 10.1002/14651858.CD012784.pub2

Lyons 2017.

Study characteristics
Methods Study design: Randomised controlled trial
Study grouping: Sedentary behaviour intervention and 1 control group (waiting list)
Assessment: Sedentary behaviour was measured using an activPAL device; fitness using the 6‐minute walk test; and body fat using dual‐energy x‐ray absorptiometry (DEXA).
Operational definition of sedentary time: Postural, as per activPAL
Randomisation method: Opaque envelopes randomly sorted by an independent individual then numbered sequentially. Randomisation stratified by the 2 cohorts for adequate numbers within each group.
Participants Baseline characteristics
Intervention
  • Age: 61.25 (5.00) years

  • Gender: 15% male

  • Race: 65% white

  • BMI: 30.00 (2.86) kg/m2

  • Education: 65% with college degree

  • N = 20


Control (waitlist)
  • Age: 61.70 (6.26) years

  • Gender: 15% male

  • Race: 65% white

  • BMI: 30.68 (4.01) kg/m2

  • Education: 70% with college degree

  • N = 20


Inclusion criteria: Aged between 55 and 79 years, BMI between 25 and 35. Ability to read and understand English. Ability to read words on a tablet‐sized device
Exclusion criteria: Self‐reported habitual physical activity more than 60 min per week. Health issues that might preclude safe walking. Psychological issues that might interfere with full participation. Current use of a wearable electronic activity monitoring system. Cardiovascular disease risk questions positive on the Physical activity readiness questionnaire ‐ PAR‐Q (doctor's consent if only about medications)
Interventions 12‐week e‐health intervention involving a wearable activity monitor (Up24, Jawbone Inc, San Francisco, CA) coupled with a tablet (Apple iPad Mini, Apple Inc, Cupertino, CA). Participants set goals for physical activity and sedentary behaviour with the help of the interventionist, monitored by the activity monitor. Participant could monitor progress through a simple interface on the tablet. Intervention was delivered through an initial consultation and weekly phone calls discussing goals and targets and other behaviour change strategies. In addition, the monitor delivered haptic prompts when the participant was inactive for extended periods (duration set by the participant). Interventionists provided training for self‐monitoring, viewing feedback, and using sedentary behaviour prompts in the app.
Outcomes Primary outcomes
Sedentary time (objective)
  • Outcome type: Continuous outcome

  • Reporting: Fully reported

  • Unit of measure: min/day

  • Direction: Lower is better


Secondary outcomes
Body fat
  • Outcome type: Continuous outcome

  • Reporting: Fully reported

  • Unit of measure: Percentage

  • Direction: Lower is better


Fitness
  • Outcome type: Continuous outcome

  • Reporting: Fully reported

  • Unit of measure: Feet

  • Direction: Higher is better

Identification Sponsorship source: This study was internally funded by the Claude D Pepper Older Americans Independence Center (P30AG024832) and Sealy Center on Aging. Additional salary support was provided by a Mentored Research Scholar Grant in Applied and Clinical Research (MRSG‐14‐165‐01‐CPPB) from the American Cancer Society, the American Heart Association (13BGIA17110021), and the Cancer Prevention Research Institute of Texas (RP140020).
Country: USA
Setting: Community
Comments: This is a feasibility study based on an RCT design (intervention/control) with N = 40 in 2 groups. Intervention based on wearable feedback over 12 weeks and telephone counselling. Shows low effect size on sedentary time (decrease) Cohen's d ~ −0.21 and slight increase in stepping activity (d ~ 0.26) and loss of body fat (−0.17), no effect on fitness
Author's name: Elizabeth J Lyons
Institution: Department of Nutrition and Metabolism, The University of Texas Medical Branch, Galveston, TX, USA
Email: ellyons@utmb.edu
Address: Elizabeth J Lyons, MPH, PhD, Department of Nutrition and Metabolism, The University of Texas Medical Branch, 301 University Blvd, Galveston, TX, 77555, USA
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was conducted using standard opaque envelopes with foil (to prevent seeing the group assignment inside the envelope) and carbon paper (to provide an audit trail). The envelopes were randomly sorted by an individual not involved in the randomisation visit process, then numbered sequentially. Randomisation was carried out using sequentially numbered, opaque, sealed envelopes according to standard protocols, with randomisation stratified by the 2 cohorts to promote adequate numbers of participants able to talk to one another through the app.
Allocation concealment (selection bias) Low risk Envelopes were randomly sorted by an individual not involved in the randomisation visit process, then numbered sequentially.
Blinding of participants and personnel (performance bias)
All outcomes High risk Intensive intervention with weekly telephone counselling, and participants encouraged to view their data at least twice per day. Control was a waitlist condition.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Use of device‐based measure, but resource limitations precluded using blinded assessors for all participants
Incomplete outcome data (attrition bias)
All outcomes Low risk Detailed description of missing data, and intention‐to‐treat analysis fully described
Selective reporting (reporting bias) Unclear risk No protocol available.
Other bias Low risk None