Trial Outcomes & Findings for Our Lifestyles Our Lives (NCT NCT02965729)
NCT ID: NCT02965729
Last Updated: 2022-08-29
Results Overview
Height was measured at sessions 1 and 10 using a stadiometer. Weight was measured at each session using a calibrated scale. BMI z-score was calculated from the Centers for Disease Control and Prevention macro program based on the sex, height, and age of the child. Change was calculated as difference between baseline and end of 10-week study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
10 weeks
Results posted on
2022-08-29
Participant Flow
Participant milestones
| Measure |
No Pedometer
Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.
|
Pedometer Only
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.
|
Pedometer Plus Step Goals
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
56
|
|
Overall Study
COMPLETED
|
17
|
22
|
45
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Our Lifestyles Our Lives
Baseline characteristics by cohort
| Measure |
No Pedometer
n=24 Participants
Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.
|
Pedometer Only
n=25 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.
|
Pedometer Plus Step Goals
n=56 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
11.4 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
11.7 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
13.1 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
12.4 years
STANDARD_DEVIATION 2.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
25 participants
n=7 Participants
|
56 participants
n=5 Participants
|
105 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 10 weeksHeight was measured at sessions 1 and 10 using a stadiometer. Weight was measured at each session using a calibrated scale. BMI z-score was calculated from the Centers for Disease Control and Prevention macro program based on the sex, height, and age of the child. Change was calculated as difference between baseline and end of 10-week study.
Outcome measures
| Measure |
No Pedometer
n=17 Participants
Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.
|
Pedometer Only
n=22 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.
|
Pedometer Plus Step Goals
n=45 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
|
|---|---|---|---|
|
BMI Z-score Change
|
0.01 z score
Standard Deviation 0.04
|
-0.03 z score
Standard Deviation 0.04
|
-0.03 z score
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: 10 weeksBMI was calculated as weight in kg divided by height in meters squared. Change was calculated as difference between baseline and end of 10-week study.
Outcome measures
| Measure |
No Pedometer
n=17 Participants
Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.
|
Pedometer Only
n=22 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.
|
Pedometer Plus Step Goals
n=45 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
|
|---|---|---|---|
|
BMI Change
|
0.43 kg/m2
Standard Deviation 0.82
|
-0.24 kg/m2
Standard Deviation 0.78
|
-0.37 kg/m2
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: 10 weeksWeight was measured using a calibrated scale. Change was calculated as difference between baseline and end of 10-week study.
Outcome measures
| Measure |
No Pedometer
n=17 Participants
Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.
|
Pedometer Only
n=22 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.
|
Pedometer Plus Step Goals
n=45 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
|
|---|---|---|---|
|
Body Weight Change
|
1.12 kg
Standard Deviation 1.9
|
0.23 kg
Standard Deviation 1.87
|
-0.49 kg
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Data were not collected for the ''No Pedometer'' cohorts.
Health-related quality of life was measured using the Kidscreen-10 Index. Change was calculated as difference between baseline and end of 10-week study. the scale ranged from 0 to 15, with higher values indicating a better outcome.
Outcome measures
| Measure |
No Pedometer
Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.
|
Pedometer Only
n=20 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.
|
Pedometer Plus Step Goals
n=39 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
|
|---|---|---|---|
|
Quality of Life Kidscreen-10 Index Change
|
—
|
2.2 units on a scale
Standard Deviation 4.5
|
0.9 units on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Data were not collected for the ''No Pedometer'' cohorts.
Physical activity enjoyment was measured using the Physical Activity Enjoyment Scale (PACES). Change was calculated as difference between baseline and end of 10-week study. The scale ranged from 0 to 32, with higher values indicating a better outcome.
Outcome measures
| Measure |
No Pedometer
Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.
|
Pedometer Only
n=20 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.
|
Pedometer Plus Step Goals
n=39 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
|
|---|---|---|---|
|
Physical Activity Enjoyment Change
|
—
|
0.02 units on a scale
Standard Deviation 8.25
|
2.66 units on a scale
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Data were not collected for the ''No Pedometer'' cohorts.
Subjective health was measured using a 1-item Likert scale ("In general, how would you say your health is?"). Change was calculated as difference between baseline and end of 10-week study. The scale ranged from 0 to 4, with higher values indicating a better outcome.
Outcome measures
| Measure |
No Pedometer
Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.
|
Pedometer Only
n=20 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.
|
Pedometer Plus Step Goals
n=39 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
|
|---|---|---|---|
|
Subjective Health Change
|
—
|
0.55 units on a scale
Standard Deviation 1.34
|
0.66 units on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: Pedometers were not worn in the "No Pedometer" cohorts and so data were not collected.
Physical activity was measured in the pedometer only and pedometer plus goals groups using an Omron pedometer (Omron HJ-324U, Omron Healthcare, Lake Forest, IL). Change was calculated as difference between baseline and end of 10-week study.
Outcome measures
| Measure |
No Pedometer
Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals.
|
Pedometer Only
n=22 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. No step goals were provided.
|
Pedometer Plus Step Goals
n=45 Participants
In addition to participating in the family-based weight management intervention, participants were given a pedometer and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10. Participants were given individualized step goals to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
|
|---|---|---|---|
|
Physical Activity Change
|
—
|
-162 steps
Standard Deviation 620
|
1185 steps
Standard Deviation 425
|
Adverse Events
No Pedometer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pedometer Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pedometer Plus Step Goals
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. Amanda Staiano
Pennington Biomedical Research Center
Phone: 225-763-2729
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place