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

Phase 2

Recruiting

• Conditions: Physical Inactivity
• Interventions: Behavioral: Self-Paced Intensity Physical Activity; Behavioral: Prescribed Moderate Intensity Physical Activity

• Registration Number: NCT05285748
• Lead Sponsor: Brown University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-23
• Study Start: 2022-03-15
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Paced Intensity Physical Activity	Self-Paced Intensity Physical Activity	-
Prescribed Moderate Intensity Physical Activity	Prescribed Moderate Intensity Physical Activity	-

Primary Outcome Measures

Name	Time	Method
Change in total volume of structured PA	Measured 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 PA	Measured daily from date of randomization for 52 weeks based on participant initiation of exercise	Participants will be instructed to indicate, in real time, each time they begin and end a PA session via EMA.

Secondary Outcome Measures

Name	Time	Method
Changes in Body Weight	Measured at baseline, and months 3, 6, 9, and 12.	Assessment of self-reported body weight by study-provided scales

Trial Locations

Locations (1)

Brown University; 🇺🇸 Providence, Rhode Island, United States