Pediatric Obesity, Weight Loss
Conditions
Keywords
behavior goals, self-monitoring, pedometer, physical activity
Brief summary
The purpose of the study was to examine the influence of step goals with pedometers to improve children's weight loss, physical activity, and psychosocial health during behavioral treatment. Children with overweight or obesity were assigned to receive the behavioral treatment alone, plus pedometers, or plus pedometers with step goals.
Detailed description
A total of 105 overweight and obese children ages 8 to 17 years participated in a 10-week family-based weight management intervention focusing on physical activity, nutrition, and behavioral modification. A quasi-experimental design was used to group cohorts into three conditions: two cohorts had no pedometer (n=24); two cohorts had pedometer only (n=25); and four cohorts had pedometer with step goals (i.e. 500 steps/day weekly increase above baseline; n=56). Height and weight were measured at baseline and week 10 and used to calculate body mass index (BMI). Analysis of covariance was performed to examine difference by condition for change in weight, BMI, and BMI z-score, controlling for age and baseline value. Differences in steps/day and psychosocial health were compared between the two pedometer conditions.
Interventions
BEHAVIORALFamily-based weight management
The Our Lifestyles, Our Lives family-based weight management intervention consisted of 10 weekly 90-minute group sessions focused on physical activity, nutrition, and behavioral modification. Parents and siblings were encouraged to join the participant in these sessions. Sessions were interactive and included cooking demonstrations, light to moderate intensity physical activity that engaged all family members, and behavioral counseling sessions in both mixed (parent and child) and parent-only format.
BEHAVIORALPedometer
In addition to participating in the family-based weight management intervention, participants were given a pedometer (Omron HJ-324U, Omron Healthcare, Lake Forest, IL) 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.
BEHAVIORALIndividualized step goals
In addition to participating in the family-based weight management intervention, participants were given a step goal to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
Sponsors
Our Lady of the Lake Hospital
American Council on Exercise
Pennington Biomedical Research Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 8-17 years old * BMI ≥ 95th percentile or have a BMI ≥ 85th percentile with comorbidities (e.g. hypertension, heart disease, type 2 diabetes, insulin resistance, sleep apnea, orthopedic problems, or fatty liver disease)
Exclusion criteria
* None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI Z-score Change | 10 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI Change | 10 weeks | BMI 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. |
| Body Weight Change | 10 weeks | Weight was measured using a calibrated scale. Change was calculated as difference between baseline and end of 10-week study. |
| Subjective Health Change | 10 weeks | 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. |
| Physical Activity Enjoyment Change | 10 weeks | 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. |
| Physical Activity Change | 10 weeks | 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. |
| Quality of Life Kidscreen-10 Index Change | 10 weeks | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Pedometer Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals. | 24 |
| 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. | 25 |
| 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). | 56 |
| Total | 105 |
Baseline characteristics
| Characteristic | Pedometer Only | Pedometer Plus Step Goals | No Pedometer | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 25 Participants | 56 Participants | 24 Participants | 105 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 11.7 years STANDARD_DEVIATION 2.1 | 13.1 years STANDARD_DEVIATION 2.6 | 11.4 years STANDARD_DEVIATION 2.5 | 12.4 years STANDARD_DEVIATION 2.5 |
| Region of Enrollment United States | 25 participants | 56 participants | 24 participants | 105 participants |
| Sex: Female, Male Female | 16 Participants | 39 Participants | 18 Participants | 73 Participants |
| Sex: Female, Male Male | 9 Participants | 17 Participants | 6 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 25 | 0 / 56 |
| other Total, other adverse events | 0 / 24 | 0 / 25 | 0 / 56 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 | 0 / 56 |
Outcome results
Primary
BMI Z-score Change
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.
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Pedometer | BMI Z-score Change | 0.01 z score | Standard Deviation 0.04 |
| Pedometer Only | BMI Z-score Change | -0.03 z score | Standard Deviation 0.04 |
| Pedometer Plus Step Goals | BMI Z-score Change | -0.03 z score | Standard Deviation 0.05 |
Secondary
BMI Change
BMI 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.
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Pedometer | BMI Change | 0.43 kg/m2 | Standard Deviation 0.82 |
| Pedometer Only | BMI Change | -0.24 kg/m2 | Standard Deviation 0.78 |
| Pedometer Plus Step Goals | BMI Change | -0.37 kg/m2 | Standard Deviation 0.92 |
Secondary
Body Weight Change
Weight was measured using a calibrated scale. Change was calculated as difference between baseline and end of 10-week study.
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Pedometer | Body Weight Change | 1.12 kg | Standard Deviation 1.9 |
| Pedometer Only | Body Weight Change | 0.23 kg | Standard Deviation 1.87 |
| Pedometer Plus Step Goals | Body Weight Change | -0.49 kg | Standard Deviation 2.06 |
Secondary
Physical Activity Change
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.
Time frame: 10 weeks
Population: Pedometers were not worn in the No Pedometer cohorts and so data were not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pedometer Only | Physical Activity Change | -162 steps | Standard Deviation 620 |
| Pedometer Plus Step Goals | Physical Activity Change | 1185 steps | Standard Deviation 425 |
Secondary
Physical Activity Enjoyment Change
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.
Time frame: 10 weeks
Population: Data were not collected for the ''No Pedometer'' cohorts.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pedometer Only | Physical Activity Enjoyment Change | 0.02 units on a scale | Standard Deviation 8.25 |
| Pedometer Plus Step Goals | Physical Activity Enjoyment Change | 2.66 units on a scale | Standard Deviation 10.9 |
Secondary
Quality of Life Kidscreen-10 Index Change
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.
Time frame: 10 weeks
Population: Data were not collected for the ''No Pedometer'' cohorts.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pedometer Only | Quality of Life Kidscreen-10 Index Change | 2.2 units on a scale | Standard Deviation 4.5 |
| Pedometer Plus Step Goals | Quality of Life Kidscreen-10 Index Change | 0.9 units on a scale | Standard Deviation 5.3 |
Secondary
Subjective Health Change
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.
Time frame: 10 weeks
Population: Data were not collected for the ''No Pedometer'' cohorts.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pedometer Only | Subjective Health Change | 0.55 units on a scale | Standard Deviation 1.34 |
| Pedometer Plus Step Goals | Subjective Health Change | 0.66 units on a scale | Standard Deviation 1 |