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Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women

Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03558828
Enrollment
301
Registered
2018-06-15
Start date
2018-08-24
Completion date
2025-06-30
Last updated
2025-08-03

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

Conditions

Physical Activity

Keywords

physical activity, women, sedentary, accelerometer, text message, group meeting, personal call, workplace, cost-effectiveness, Sequential Multiple Assignment Randomized Trial, adaptive intervention, Actigraph, Fitbit, iCardia

Brief summary

This study employs a Sequential Multiple Assignment Randomized Trial (SMART) and aims to determine the most effective adaptive intervention combining four efficacious treatments (enhanced physical activity monitor, motivational text messages, motivational personal calls, group meetings) to increase physical activity and improve cardiovascular health among sedentary employed women.

Detailed description

The long-term goal of this research program is to develop cost-effective strategies to increase moderate- intensity physical activity among sedentary women. Fewer than half of U.S. women meet recommendations for moderate-intensity physical activity, and thereby are at increased risk for cardiovascular disease. When provided a physical activity program, between 25-60% of women either fail to adopt it or fail to adhere after six months. Physical activity health benefits are further negatively impacted by the fact that sedentary behavior at many worksites exacerbates low physical activity. Among efficacious treatments for increasing physical activity for women, four have had promising results: (1) enhanced physical activity monitor treatment (PA monitor with goal setting and a physical activity prescription); (2) motivational text messages; (3) motivational personal calls; and (4) group meetings. While each of these treatments has proven efficacy, they differ on resource use and cost, and there is heterogeneity in response. When treatments have heterogeneity of response, adaptive interventions can help close that gap. Adaptive interventions start with an initial treatment and then transition to an augmented treatment for non-responders. This study aims to determine the most effective adaptive intervention combining four efficacious treatments (enhanced physical activity monitor, motivational text messages, motivational personal calls, group meetings) to increase physical activity (step counts per day, minutes moderate/vigorous physical activity per week) and improve cardiovascular health (aerobic fitness, body composition) among sedentary employed women. The investigators will also assess treatment effects on intervention targets (physical activity benefits, physical activity barriers, physical activity self-efficacy, and social support). A Sequential Multiple Assignment Randomized Trial (SMART) design will address the following aims: 1) Among non-responders to the initial treatments (enhanced physical activity monitor and enhanced physical activity monitor+ motivational text messages), compare the two augmented treatments (motivational personal calls and group meetings); 2a) Compare the two initial treatments and; 2b) Compare the four adaptive interventions embedded in the SMART on physical activity and cardiovascular health; 3) Identify mediators and moderators of the initial and augmented treatments on physical activity and cardiovascular health; 4) Compare the cost-effectiveness of the four adaptive interventions from the societal perspective which includes both program costs and participant costs. The investigators will recruit 312 sedentary women, aged 18 to 70, who are employed at a large urban academic medical center. Data will be collected on physical activity (self- report, device), cardiovascular health, physical activity benefits, physical activity barriers, physical activity self-efficacy, social support, and program and participant costs. Data will be collected at baseline, weeks 9-10 (when response to initial treatment is assessed), weeks 35-36, and weeks 51-52. The investigators expect to identify an optimal adaptive intervention for improving physical activity and cardiovascular health that minimizes costs and burden to women who respond to less intensive treatments, while maximizing benefits for those who need a more intensive approach.

Interventions

BEHAVIORALStep 1: PA Monitor

The participant will receive an enhanced physical activity monitor treatment for weeks 1-8, which includes goal setting with a physical activity prescription, and self-monitoring with a physical activity monitor.

BEHAVIORALStep 1: PA Monitor + Text

The participant will receive an enhanced physical activity monitor treatment for weeks 1-8, which includes goal setting with a physical activity prescription, and self-monitoring with a physical activity monitor. In addition, these participants will receive motivational text messages. For participants who remain less than halfway to their daily step goal by a designated daily time, a motivational text message with a strategy to overcome barriers will be sent.

BEHAVIORALStep 2: PA Monitor with Calls

Nonresponders to the enhanced physical activity monitor, will receive an augmented treatment. The participant will continue to receive an enhanced physical activity monitor treatment for weeks 9-34. In addition they will receive ten brief motivational telephone calls, made by an interventionist, every two to three weeks during weeks 9-34.

BEHAVIORALStep 2: PA Monitor with Meetings

Nonresponders to the enhanced physical activity monitor, will receive an augmented treatment. The participant will continue to receive an enhanced physical activity monitor treatment for weeks 9-34. In addition, the participant will take part in five 45-minute group meetings held every four to six weeks during Weeks 9-34.

BEHAVIORALStep 2: PA Monitor + Texts with Calls

Nonresponders to the enhanced physical activity monitor plus text messaging, will receive an augmented treatment. The participant will continue to receive an enhanced physical activity monitor treatment for weeks 9-34. In addition, these participants will continue to receive motivational text messages. For participants who remain less than halfway to their daily step goal by a designated daily time, a motivational text message with a strategy to overcome barriers will be sent. In addition they will receive ten brief motivational telephone calls, made by an interventionist, every two to three weeks during weeks 9-34.

BEHAVIORALStep 2: PA Monitor + Texts with Meetings

Nonresponders to the enhanced physical activity monitor plus text messaging, will receive an augmented treatment. The participant will continue to receive an enhanced physical activity monitor treatment for weeks 9-34. In addition, these participants will continue to receive motivational text messages. For participants who remain less than halfway to their daily step goal by a designated daily time, a motivational text message with a strategy to overcome barriers will be sent. In addition, the participant will take part in five 45-minute group meetings held every four to six weeks during Weeks 9-34.

BEHAVIORALStep 3: PA Monitor

During Weeks 35-50, all women will receive enhanced physical activity monitors only.

Sponsors

University of Illinois at Chicago
CollaboratorOTHER
Michigan State University
CollaboratorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH
Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

A Sequential Multiple Assignment Randomized Trial (SMART) design is used for this study.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Female employee at study site * Aged 18 to 70 * Able to speak/read English * Owns a smartphone with text messaging capability * Willing to receive text messages at the proposed pace * We will include participants who have Type 1 diabetes, or Type 2 diabetes with an A1C ≥ 9.0%, or have an A1C of ≥ 6.5% without a prior diabetes diagnosis, only if they have been given clearance by their health care provider * Without a disability that inhibits walking as determined by the PAR-Q & You (Physical Activity Readiness Questionnaire)

Exclusion criteria

* Major signs/symptoms of pulmonary or cardiovascular disease * Systolic BP ≥ 160 and/or diastolic BP ≥ 100 * Sufficiently or overly active, as determined by a physical activity monitor worn for one week, indicating averaging ≥ 7,500 steps per day (somewhat active)

Design outcomes

Primary

MeasureTime frameDescription
Physical Activity-StepsBaseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for steps.Physical activity-Steps: Average daily steps were measured with ActiGraph worn on the right hip during waking hours for one week.
Physical Activity- Moderate to Vigorous Physical Activity (MVPA)Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for MVPA.Average daily minutes of Moderate to Vigorous Physical Activity (MVPA) were measured with ActiGraph worn on the right hip during waking hours for one week.

Secondary

MeasureTime frameDescription
Cardiovascular Health (1)Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for aerobic fitness.Aerobic fitness: participants step in place to a predesignated height for 2 minutes and the average number of steps taken in 2 minutes are counted.
Cardiovascular Health (2)Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for BMI.Body composition: Average BMI (weight measured in pounds; height measured in inches) was measured utilizing BMI calculation formula: BMI = Weight (kg) / Height (m)²
Cardiovascular Health (3)Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for waist measurement.Body composition: Average waist circumference was measured in inches.

Countries

United States

Participant flow

Recruitment details

Response to reviewer's comment #2- Each arm includes a specific title and time period. For Column #7 during the maintenance period, a total of 301 participants were analyzed. If we were to include 301 again in this column, the total would add up to 602, which would count the same participants twice. To avoid the double-counting and to keep the total participant number as 301, I've added column #7 but entered n as 0 in the maintenance period column. Comment #3. Response: footnote removed

Pre-assignment details

Excluded: 453 * Unable to be reached: 163 * Not Interested: 193 * Ineligible: 97 * failed phone screening: 14 * failed health screening: 33 * failed physical activity screening: 50

Participants by arm

ArmCount
Step1: Initial Treatment (Weeks 1-8) Enhanced Physical Activity Monitor Only
Step1: Initial Treatment (weeks 1-8) enhanced physical activity monitor only: In this group, participants were randomly assigned to an enhanced physical activity monitor only, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. For baseline characteristics, this step includes both responders and non-responders from the physical activity monitor-only treatment group.
149
Step1: Initial Treatment (Weeks 1-8) Enhanced Physical Activity Monitor + Text Messages
Step1: Initial Treatment (weeks 1-8) enhanced physical activity monitor +motivational text messaging: In this group, participants were randomly assigned to an enhanced physical activity monitor (Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps) + text messages. For baseline characteristics, this step includes both responders and non-responders from the physical activity monitor + text messages treatment group.
152
Total301

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Overall Studydropped before the intervention110000
Overall StudyLost to Follow-up433523

Baseline characteristics

CharacteristicStep1: Initial Treatment (Weeks 1-8) Enhanced Physical Activity Monitor OnlyStep1: Initial Treatment (Weeks 1-8) Enhanced Physical Activity Monitor + Text MessagesTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
149 Participants152 Participants301 Participants
Age, Continuous45.1 years
STANDARD_DEVIATION 11.6
46.1 years
STANDARD_DEVIATION 11.2
45.6 years
STANDARD_DEVIATION 11.4
Average daily minutes of moderate/vigorous PA (MVPA)13.5 Number pf MVPA minutes/day (M, 95% CI)13.7 Number pf MVPA minutes/day (M, 95% CI)13.6 Number pf MVPA minutes/day (M, 95% CI)
Average daily steps4913.95 Number of steps (M, 95% CI)5082.05 Number of steps (M, 95% CI)4998 Number of steps (M, 95% CI)
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
7 Participants16 Participants23 Participants
Race (NIH/OMB)
Black or African American
44 Participants48 Participants92 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
20 Participants14 Participants34 Participants
Race (NIH/OMB)
White
78 Participants74 Participants152 Participants
Region of Enrollment
United States
149 participants152 participants301 participants
Sex: Female, Male
Female
149 Participants152 Participants301 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 760 / 810 / 380 / 350 / 350 / 36
other
Total, other adverse events
3 / 760 / 810 / 380 / 350 / 350 / 36
serious
Total, serious adverse events
0 / 760 / 810 / 380 / 350 / 350 / 36

Outcome results

Primary

Physical Activity- Moderate to Vigorous Physical Activity (MVPA)

Average daily minutes of Moderate to Vigorous Physical Activity (MVPA) were measured with ActiGraph worn on the right hip during waking hours for one week.

Time frame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for MVPA.

Population: Total N=301 participants were analyzed.

ArmMeasureValue (MEAN)
Enhanced Physical Activity Monitor OnlyPhysical Activity- Moderate to Vigorous Physical Activity (MVPA)17.4 Number of MVPA minutes/day
Enhanced Physical Activity Monitor+ Motivational Text MessagesPhysical Activity- Moderate to Vigorous Physical Activity (MVPA)18.0 Number of MVPA minutes/day
Enhanced Physical Activity Monitor Only+ Personal CallsPhysical Activity- Moderate to Vigorous Physical Activity (MVPA)18.8 Number of MVPA minutes/day
Enhanced Physical Activity Monitor Only+ Group MeetingsPhysical Activity- Moderate to Vigorous Physical Activity (MVPA)17.9 Number of MVPA minutes/day
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal CallsPhysical Activity- Moderate to Vigorous Physical Activity (MVPA)18.6 Number of MVPA minutes/day
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group MeetingsPhysical Activity- Moderate to Vigorous Physical Activity (MVPA)17.7 Number of MVPA minutes/day
GEEs
Primary

Physical Activity-Steps

Physical activity-Steps: Average daily steps were measured with ActiGraph worn on the right hip during waking hours for one week.

Time frame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for steps.

Population: Total N=301 participants were analyzed.

ArmMeasureValue (MEAN)
Enhanced Physical Activity Monitor OnlyPhysical Activity-Steps5637.2 Number of steps/day
Enhanced Physical Activity Monitor+ Motivational Text MessagesPhysical Activity-Steps5863.3 Number of steps/day
Enhanced Physical Activity Monitor Only+ Personal CallsPhysical Activity-Steps5603.9 Number of steps/day
Enhanced Physical Activity Monitor Only+ Group MeetingsPhysical Activity-Steps5631.6 Number of steps/day
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal CallsPhysical Activity-Steps5636.7 Number of steps/day
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group MeetingsPhysical Activity-Steps5322.0 Number of steps/day
GEEs
Secondary

Cardiovascular Health (1)

Aerobic fitness: participants step in place to a predesignated height for 2 minutes and the average number of steps taken in 2 minutes are counted.

Time frame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for aerobic fitness.

Population: Total N=301 participants were analyzed.

ArmMeasureValue (MEAN)
Enhanced Physical Activity Monitor OnlyCardiovascular Health (1)85.7 Number of steps/2 minutes
Enhanced Physical Activity Monitor+ Motivational Text MessagesCardiovascular Health (1)87.1 Number of steps/2 minutes
Enhanced Physical Activity Monitor Only+ Personal CallsCardiovascular Health (1)86.3 Number of steps/2 minutes
Enhanced Physical Activity Monitor Only+ Group MeetingsCardiovascular Health (1)89.9 Number of steps/2 minutes
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal CallsCardiovascular Health (1)86 Number of steps/2 minutes
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group MeetingsCardiovascular Health (1)88.7 Number of steps/2 minutes
Secondary

Cardiovascular Health (2)

Body composition: Average BMI (weight measured in pounds; height measured in inches) was measured utilizing BMI calculation formula: BMI = Weight (kg) / Height (m)²

Time frame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for BMI.

Population: Total N=301 participants were analyzed.

ArmMeasureValue (MEAN)
Enhanced Physical Activity Monitor OnlyCardiovascular Health (2)31.8 weight (pounds)/height (Inches)^2x703
Enhanced Physical Activity Monitor+ Motivational Text MessagesCardiovascular Health (2)32.4 weight (pounds)/height (Inches)^2x703
Enhanced Physical Activity Monitor Only+ Personal CallsCardiovascular Health (2)31.3 weight (pounds)/height (Inches)^2x703
Enhanced Physical Activity Monitor Only+ Group MeetingsCardiovascular Health (2)31.6 weight (pounds)/height (Inches)^2x703
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal CallsCardiovascular Health (2)32.2 weight (pounds)/height (Inches)^2x703
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group MeetingsCardiovascular Health (2)32.1 weight (pounds)/height (Inches)^2x703
Secondary

Cardiovascular Health (3)

Body composition: Average waist circumference was measured in inches.

Time frame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for waist measurement.

Population: Total N=301 participants were analyzed.

ArmMeasureValue (MEAN)
Enhanced Physical Activity Monitor OnlyCardiovascular Health (3)38.1 Inches
Enhanced Physical Activity Monitor+ Motivational Text MessagesCardiovascular Health (3)38.7 Inches
Enhanced Physical Activity Monitor Only+ Personal CallsCardiovascular Health (3)38.4 Inches
Enhanced Physical Activity Monitor Only+ Group MeetingsCardiovascular Health (3)39 Inches
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal CallsCardiovascular Health (3)39.8 Inches
Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group MeetingsCardiovascular Health (3)38.7 Inches

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026