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| Name | Class |
|---|---|
| Our Lady of the Lake Hospital | OTHER |
| American Council on Exercise | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Pedometer | Active Comparator | Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals. |
|
| Pedometer Only | Active Comparator | 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 | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-based weight management | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 weeks |
| Body Weight Change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda E Staiano, PhD | Pennington Biomedical Research Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28440662 | Result | Staiano AE, Beyl RA, Hsia DS, Jarrell AR, Katzmarzyk PT, Mantzor S, Newton RL Jr, Tyson P. Step Tracking with Goals Increases Children's Weight Loss in Behavioral Intervention. Child Obes. 2017 Aug;13(4):283-290. doi: 10.1089/chi.2017.0047. Epub 2017 Apr 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Pedometer | Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals. |
| FG001 | 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. |
| FG002 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Pedometer | Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals. |
| BG001 | Pedometer Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | z score | 10 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Pedometer | Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amanda Staiano | Pennington Biomedical Research Center | 225-763-2729 | amanda.staiano@pbrc.edu |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000072936 | Fitness Trackers |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
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|
| Pedometer | Behavioral | 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. |
|
|
| Individualized step goals | Behavioral | 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). |
|
Weight was measured using a calibrated scale. Change was calculated as difference between baseline and end of 10-week study.
| 10 weeks |
| 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. | 10 weeks |
| 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. | 10 weeks |
| 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. | 10 weeks |
| 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. | 10 weeks |
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.
| BG002 | 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). |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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). |
|
|
| 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. | Posted | Mean | Standard Deviation | kg/m2 | 10 weeks |
|
|
|
| Secondary | Body Weight Change | Weight was measured using a calibrated scale. Change was calculated as difference between baseline and end of 10-week study. | Posted | Mean | Standard Deviation | kg | 10 weeks |
|
|
|
| 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. | Data were not collected for the ''No Pedometer'' cohorts. | Posted | Mean | Standard Deviation | units on a scale | 10 weeks |
|
|
|
| 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. | Data were not collected for the ''No Pedometer'' cohorts. | Posted | Mean | Standard Deviation | units on a scale | 10 weeks |
|
|
|
| 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. | Data were not collected for the ''No Pedometer'' cohorts. | Posted | Mean | Standard Deviation | units on a scale | 10 weeks |
|
|
|
| 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. | Pedometers were not worn in the "No Pedometer" cohorts and so data were not collected. | Posted | Mean | Standard Deviation | steps | 10 weeks |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | 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). | 0 | 56 | 0 | 56 | 0 | 56 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |