Pediatric ObesityOLOLNCT02965729
Our Lifestyles Our Lives
A study testing Family-based weight management, Pedometer and Individualized step goals in people with Pediatric Obesity and Weight Loss, run by Pennington Biomedical Research Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Weight Loss
- What is being tested?
- Family-based weight management, Pedometer and Individualized step goals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- None.
About this study
Official title: Our Lifestyles, Our Lives: Obesity Treatment and Physical Activity Promotion for Underserved Children and Adolescents
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.
Read the 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.
- Conditions
- Pediatric Obesity, Weight Loss
- Being tested
- Family-based weight management, Pedometer, Individualized step goals
- Keywords
- behavior goals, self-monitoring, pedometer, physical activity
- Medical subject headings
- Pediatric Obesity, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based weight managementBehavioural
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.
PedometerBehavioural
Also called Activity monitor
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 goalsBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| No Pedometer | Active comparator | Participants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals. Receives: Behavioral: Family-based weight management |
| 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. Receives: Behavioral: Family-based weight management; Behavioral: Pedometer |
| 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). Receives: Behavioral: Family-based weight management; Behavioral: Pedometer; Behavioral: Individualized step goals |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (6)
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.
Measured: 10 weeks
Body Weight Change
Weight was measured using a calibrated scale. Change was calculated as difference between baseline and end of 10-week study.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startJul 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Our Lady of the Lake Hospital, American Council on Exercise
- Responsible party
- Principal investigator, Amanda Staiano, Pennington Biomedical Research Center
- Investigators
- Amanda E Staiano, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965729
- Sponsor's protocol ID
- PBRC 2014-012
- Acronym
- OLOL
- Status last verified
- Aug 2022
- First submitted
- 14 Nov 2016
- Last updated
- 29 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28440662
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Our Lifestyles, Our Lives: Obesity Treatment and Physical Activity Promotion for Underserved Children and Adolescents
- ClinicalTrials.gov ID
- NCT02965729
- Acronym / sponsor ID
- OLOL / PBRC 2014-012
- Conditions
- Pediatric Obesity, Weight Loss
- Keywords
- behavior goals, self-monitoring, pedometer, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Our Lady of the Lake Hospital, American Council on Exercise
- Study start
- Jul 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Posted 7 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Pedometer | Active comparator | Behavioral: Family-based weight managementParticipants only participated in the family-based weight management intervention. Participants were not given a pedometer or step goals. |
| Pedometer Only | Active comparator | Behavioral: Family-based weight management, Behavioral: PedometerIn 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 | Behavioral: Family-based weight management, Behavioral: Pedometer, Behavioral: Individualized step goalsIn 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). |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-based weight managementThe "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. | Behavioural | No Pedometer, Pedometer Only, Pedometer Plus Step Goals |
| PedometerAlso: Activity monitorIn 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. | Behavioural | Pedometer Only, Pedometer Plus Step Goals |
| Individualized step goalsIn 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). | Behavioural | Pedometer Plus Step Goals |
Primary outcome
BMI Z-score Change
Time frame: 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.
6 secondary outcomes
BMI Change
Time frame: 10 weeks
Body Weight Change
Time frame: 10 weeks
Quality of Life Kidscreen-10 Index Change
Time frame: 10 weeks
Physical Activity Enjoyment Change
Time frame: 10 weeks
Subjective Health Change
Time frame: 10 weeks
Physical Activity Change
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28440662Staiano 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.
- Individual participant dataSharing planned: No
Related trials for Pediatric Obesity
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
Not yet recruiting
Weight Gain in Pediatric Leukemia Survivors
Leukemia, Pediatric Acute Lymphoblastic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda E Staiano, PhD principal investigator
Pennington Biomedical Research Center
Questions about this trial
What is this clinical trial studying?
A study testing Family-based weight management, Pedometer and Individualized step goals in people with Pediatric Obesity and Weight Loss, run by Pennington Biomedical Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI Z-score Change (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02965729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.