Trial Outcomes & Findings for Girls on the Move Intervention to Increase Physical Activity Among Middle School Girls (NCT NCT01503333)

Results Overview

Minutes of MVPA were measured via ActiGraph GT3X+ accelerometers worn on an elastic belt at the right hip for 7 consecutive days, including 5 weekdays and 2 weekend days at post-intervention. Monitors were set to start collecting and storing data in raw format beginning 5:00 A.M. on the day after they were distributed to girls each school. Data were re-integrated to 15-second epochs and processed using established intensity cut-points. One week after distribution, data collectors returned to each school to collect the accelerometers. The majority (1386 \[post-intervention\] of 1519 girls \[baseline\], 91.24%) provided at least 8 hours of data on 3 weekdays and 1 weekend day. An imputation approach based on all available data in hour blocks on all 7 days was implemented. Wear time was standardized to 14 hours/weekday (one hour before each school's actual start time; 7 hours during school; 6 hours after school) and 10 hours/weekend day (later awake time from 11 a.m. to 9 p.m.).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1543 participants

Primary outcome timeframe

Minutes of moderate to vigorous physical activity per hour at post-intervention (after 17-week intervention)

Results posted on

2018-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	Control The control condition completed data collection activities and received their usual school offerings, such as physical education.	Physical Activity Intervention The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school. Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
Overall Study STARTED	777	766
Overall Study Completed Baseline	766	753
Overall Study Completed Post-intervention	680	706
Overall Study COMPLETED	437	461
Overall Study NOT COMPLETED	340	305

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

766 are in control group, and 753 are in intervention group.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=766 Participants The control condition completed data collection activities and received their usual school offerings, such as physical education.	Physical Activity Intervention n=753 Participants The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school. Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.	Total n=1519 Participants Total of all reporting groups
Age, Categorical <=18 years	766 Participants n=5 Participants	753 Participants n=7 Participants	1519 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	12.05 years STANDARD_DEVIATION 1.02 • n=5 Participants • 766 are in control group, and 753 are in intervention group.	12.05 years STANDARD_DEVIATION 0.99 • n=7 Participants • 766 are in control group, and 753 are in intervention group.	12.05 years STANDARD_DEVIATION 1.01 • n=5 Participants • 766 are in control group, and 753 are in intervention group.
Sex: Female, Male Female	766 Participants n=5 Participants	753 Participants n=7 Participants	1519 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	90 Participants n=5 Participants	111 Participants n=7 Participants	201 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	629 Participants n=5 Participants	603 Participants n=7 Participants	1232 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	47 Participants n=5 Participants	39 Participants n=7 Participants	86 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants	26 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	416 Participants n=5 Participants	340 Participants n=7 Participants	756 Participants n=5 Participants
Race (NIH/OMB) White	198 Participants n=5 Participants	214 Participants n=7 Participants	412 Participants n=5 Participants
Race (NIH/OMB) More than one race	94 Participants n=5 Participants	96 Participants n=7 Participants	190 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	34 Participants n=5 Participants	71 Participants n=7 Participants	105 Participants n=5 Participants

PRIMARY outcome

Timeframe: Minutes of moderate to vigorous physical activity per hour at post-intervention (after 17-week intervention)

Population: The majority (1386 \[post-intervention\] of 1519 girls \[baseline\], 91.24%) provided at least 8 hours of data on 3 weekdays and 1 weekend day.

Minutes of MVPA were measured via ActiGraph GT3X+ accelerometers worn on an elastic belt at the right hip for 7 consecutive days, including 5 weekdays and 2 weekend days at post-intervention. Monitors were set to start collecting and storing data in raw format beginning 5:00 A.M. on the day after they were distributed to girls each school. Data were re-integrated to 15-second epochs and processed using established intensity cut-points. One week after distribution, data collectors returned to each school to collect the accelerometers. The majority (1386 \[post-intervention\] of 1519 girls \[baseline\], 91.24%) provided at least 8 hours of data on 3 weekdays and 1 weekend day. An imputation approach based on all available data in hour blocks on all 7 days was implemented. Wear time was standardized to 14 hours/weekday (one hour before each school's actual start time; 7 hours during school; 6 hours after school) and 10 hours/weekend day (later awake time from 11 a.m. to 9 p.m.).

Outcome measures

Outcome measures
Measure	Control n=680 Participants The control condition completed data collection activities and received their usual school offerings, such as physical education.	Physical Activity Intervention n=706 Participants The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school. Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
Minutes of Moderate to Vigorous Physical Activity (MVPA) Post-intervention	3.27 mean minutes per hour Standard Deviation 1.49	3.27 mean minutes per hour Standard Deviation 1.49

SECONDARY outcome

Timeframe: Cardiovascular fitness after 17-week intervention (post-intervention)

Between group comparison measured by number of laps run in a progressive shuttle run test. CV fitness was assessed via estimation of maximal oxygen consumption.

Outcome measures

Outcome measures
Measure	Control n=680 Participants The control condition completed data collection activities and received their usual school offerings, such as physical education.	Physical Activity Intervention n=706 Participants The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school. Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
Cardiovascular Fitness (Aerobic Performance)	37.32 ml/kg/min Standard Deviation 5.28	37.51 ml/kg/min Standard Deviation 5.19

SECONDARY outcome

Timeframe: Body mass index z-score at post-intervention (after 17-week intervention)

To obtain BMI-z score, height and weight were assessed. Height was measured to nearest 0.1 cm using portable stadiometer. Weight was assessed to nearest 0.1 kg with foot-to-foot bioelectric impedance analysis scale. BMI was calculated and then converted into a percentile using age- and sex-specific reference values from the Centers for Disease Control and Prevention growth charts to determine BMI-z score.

Outcome measures

Outcome measures
Measure	Control n=680 Participants The control condition completed data collection activities and received their usual school offerings, such as physical education.	Physical Activity Intervention n=706 Participants The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school. Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
Body Mass Index (BMI) Z-score	1.01 z-score Standard Error 0.01	0.99 z-score Standard Error 0.01

SECONDARY outcome

Timeframe: Percent body fat at post-intervention (immediately after 17-week intervention)

Percent body fat estimated via a foot-to-foot body weight scale with bioelectrical impedance analysis capabilities.

Outcome measures

Outcome measures
Measure	Control n=680 Participants The control condition completed data collection activities and received their usual school offerings, such as physical education.	Physical Activity Intervention n=706 Participants The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school. Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
Percent Body Fat	30.67 percent body fat Standard Error 0.14	30.30 percent body fat Standard Error 0.14

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 months after the end of the 17-week intervention

Minutes of MVPA were measured via ActiGraph GT3X+ accelerometers worn on an elastic belt at the right hip for 7 consecutive days, including 5 weekdays and 2 weekend days at 9-month follow up. Monitors were set to start collecting and storing data in raw format beginning 5:00 A.M. on the day after they were distributed to girls each school. Data were re-integrated to 15-second epochs and processed using established intensity cut-points. One week after distribution, data collectors returned to each school to collect the accelerometers. An imputation approach based on all available data in hour blocks on all 7 days was implemented. Wear time was standardized to 14 hours/weekday (one hour before each school's actual start time; 7 hours during school; 6 hours after school) and 10 hours/weekend day (later awake time from 11 a.m. to 9 p.m.).

Outcome measures

Outcome measures
Measure	Control n=766 Participants The control condition completed data collection activities and received their usual school offerings, such as physical education.	Physical Activity Intervention n=753 Participants The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school. Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
Minutes of Moderate-to-Vigorous Physical Activity 9-month Follow up	2.64 mean minutes per hour Standard Deviation 1.15	2.59 mean minutes per hour Standard Deviation 1.19

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to post-intervention

To assess positive consequences of physical activity, girls completed 10-item Perceived Benefits Scale. Response choices ranged form (0) not at all true to (3) very true. Higher score means better outcome.

Outcome measures

Outcome measures
Measure	Control n=766 Participants The control condition completed data collection activities and received their usual school offerings, such as physical education.	Physical Activity Intervention n=753 Participants The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school. Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
Perceived Benefits of Physical Activity	2.22 score on a scale Standard Deviation 0.51	2.29 score on a scale Standard Deviation 0.53

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to post-intervention

To assess obstacles interfering with physical activity, girls completed a 16-item Perceived Barriers Scale. Response choices ranged from (0) not at all true to (3) very true. Higher score means worse outcome.

Outcome measures

Outcome measures
Measure	Control n=766 Participants The control condition completed data collection activities and received their usual school offerings, such as physical education.	Physical Activity Intervention n=753 Participants The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school. Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
Perceived Barriers to Physical Activity	1.14 score on a scale Standard Deviation 0.60	1.26 score on a scale Standard Deviation 0.63

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to post-intervention

To measure girls' confidence in their ability to attain physical activity during their free time when facing barriers or not, a 6-item Physical Activity Self-Efficacy scale was used. Response choices ranged from (0) disagree a lot to (3) agree a lot. Higher score means better outcome.

Outcome measures

Outcome measures
Measure	Control n=766 Participants The control condition completed data collection activities and received their usual school offerings, such as physical education.	Physical Activity Intervention n=753 Participants The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school. Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
Physical Activity Self-Efficacy	2.14 score on a scale Standard Deviation 0.60	2.12 score on a scale Standard Deviation 0.64

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to post-intervention

To measure assistance for physical activity received form others, an 8-item Social Support Scale was used. Response choices ranged form (0) never to (3) often. Higher score means better outcome.

Outcome measures

Outcome measures
Measure	Control n=766 Participants The control condition completed data collection activities and received their usual school offerings, such as physical education.	Physical Activity Intervention n=753 Participants The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school. Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
Social Support for Physical Activity	1.73 score on a scale Standard Deviation 0.86	1.87 score on a scale Standard Deviation 0.82

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to post-intervention

To assess feelings or fun regarding physical activity, a 6-item Physical Activity Enjoyment Scale was used. Response choices ranged form (0) not at all true to (3) very true. Higher score means better outcome.

Outcome measures

Outcome measures
Measure	Control n=766 Participants The control condition completed data collection activities and received their usual school offerings, such as physical education.	Physical Activity Intervention n=753 Participants The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school. Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
Enjoyment of Physical Activity	2.11 score on a scale Standard Deviation 0.72	2.11 score on a scale Standard Deviation 0.67

OTHER_PRE_SPECIFIED outcome

Timeframe: baseline to post-intervention

To assess feelings regarding physical activity, a 10-item scale was used. Response choices ranged from (0) not true to (4) very true. Higher score means better outcome.

Outcome measures

Outcome measures
Measure	Control n=766 Participants The control condition completed data collection activities and received their usual school offerings, such as physical education.	Physical Activity Intervention n=753 Participants The intervention group completed data collection activities and received the 17-week intervention which included 3 components to help the girls increase their physical activity: 1) two face-to-face motivational interviewing sessions (one at the beginning and the other near the end of the intervention period) with a school nurse/trained counselor; 2) motivational feedback tailored based on each girl's survey responses and delivered via an iPad shortly after the intervention midpoint; and 3) after-school physical activity club for 90 minutes 3 days per week at each girl's school. Physical activity intervention: Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
Motivation for Physical Activity	3.48 score on a scale Standard Deviation 0.69	3.48 score on a scale Standard Deviation 0.68

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Physical Activity Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lorraine Robbins

Michigan State University College of Nursing

Phone: 517-353-3011

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place