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Comparing Self-paced Versus Moderate Intensity Physical Activity Recommendation for Midlife Adults

Comparing a Recommendation for Self-paced Versus Moderate Intensity Physical Activity for Midlife Adults: an RCT

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05285748
Enrollment
258
Registered
2022-03-18
Start date
2022-03-15
Completion date
2026-05-31
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Inactivity

Keywords

Physical activity, Exercise, Self-pacing

Brief summary

We will randomly assign (blocked on Gender (female, male, other), body mass index (BMI; overweight \[25 \< BMI \< 30\]) or obese (30 \< BMI \<40) and pain status (chronic pain vs not)) adults ages 50-64 into either; (a) self-selected intensity (i.e., SELF-PACED) or (b) prescribed moderate intensity (i.e., PRESCRIBED) conditions. Prior to randomization, persons responding to our ads will participate in the following: (1) telephone screening with the study research assistant (RA) to establish eligibility; (2) an orientation session to obtain more information about the study; and, after providing informed consent (3) baseline assessment and screening (bodyweight, maximal fitness test, dietary intake, and questionnaires to assess potential covariates). Prior to randomization, the RA will give participants an accelerometer to assess baseline physical activity (PA) behavior over a one-week period. Participants will then be randomized to one of the two study conditions. Following randomization, all participants will receive our theory-based PA promotion intervention to help them overcome barriers to regular PA. All participants will be given chest strap heart rate (HR) monitors and instructions on wrist palpation. Follow-up assessments will consist of accelerometry for one-week periods at months 3, 6, 9, and 12, ecological momentary assessment (EMA) throughout the 12 months and bodyweight at 3-month intervals.

Interventions

BEHAVIORALSelf-Paced Intensity Physical Activity

Participants are given a prescription to engage in 150-300 minutes per week of structured exercise with an emphasis on walking. For this study arm, participants are given the explicit recommendation to engage in self-selected intensity PA.

BEHAVIORALPrescribed Moderate Intensity Physical Activity

Participants are given a prescription to engage in 150-300 minutes per week of structured exercise with an emphasis on walking. For this study arm, participants are given the explicit recommendation to engage in moderate intensity PA consistent with national guidelines.

Sponsors

Brown University
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* ages 50-64 * BMI 25-40 * Sedentary or low-active, defined as participating in \< 60 min/week of structured exercise * Has a smart phone that can connect to the internet at least once every few days and is compatible with smartphone app

Exclusion criteria

* Medical symptoms/conditions that may make unsupervised exercise unsafe (specific

Design outcomes

Primary

MeasureTime frameDescription
Change in total volume of structured PAMeasured at baseline, and months 3, 6, 9, and 12.Minutes of PA weighted by intensity, expressed in metabolic equivalent (MET) minutes as determined by accelerometers (Actigraph \[model wGT3x-BT\]) worn during one-week periods.
Minutes per week of PAMeasured daily from date of randomization for 52 weeks based on participant initiation of exerciseParticipants will be instructed to indicate, in real time, each time they begin and end a PA session via EMA.

Secondary

MeasureTime frameDescription
Changes in Body WeightMeasured at baseline, and months 3, 6, 9, and 12.Assessment of self-reported body weight by study-provided scales

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDavid M Williams, Ph.D.

Brown University School of Public Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026