The Sedentary to Active Rising to Thrive (START) Trial

Summary

The goal of this behavioral clinical trial is to compare two different ways of becoming less sedentary and more active in 60 older adults at elevated risk of becoming frail.

The main question this project aims to answer are whether participants in each intervention are able to gradually replace 30 minutes of sedentary (sitting-like) behavior with very light walking over 60 days.

There are other questions this project aims to answer that include:

1. whether it is easier to replace sedentary behavior with one 30-minute walking bout or three 10-minute walking bouts
2. whether becoming less sedentary and more active leads to feeling better, have less stress, pain, and fatigue and have more confidence in becoming more regularly active
3. whether becoming less sedentary and more active leads to better regulation of inflammation and metabolism

Participants will be randomized into one of two sedentary reduction behavior programs; one program that gradually replaces sedentary time with one 30-minute walking bout and the other program that gradually replaces sedentary time with three 10-minute walking bouts in the morning, afternoon, and evening. Researchers will compare both programs to see which one is easier to achieve and maintain over 60 days.

Conditions

• Sedentary Time
• Frailty

Interventions

BEHAVIORAL

Continuous sedentary reduction intervention

During Phase 1, one minute of sedentary time will be replaced with very light to light intensity walking at three different times during the day, every day for 10 days, reaching three separate 10-minute walking intervals (or bouts). During Phase 2, the three 10-minute walking bouts will be gradually combined into one 30-minute bout over the course of 20 days.

BEHAVIORAL

Bouted sedentary reduction intervention

During Phase 1, one minute of sedentary time will be replaced with very light to light intensity walking at three different times during the day, every day for 10 days, reaching three separate 10-minute walking intervals (or bouts). During Phase 2, the three 10-minute walking bouts will be maintained over the course of 20 days.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Amal Wanigatunga, PhD · Johns Hopkins Blomberg School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-11-28

Primary Completion

2025-11-04

Completion

2027-06-30

Countries

• United States

Study Locations