- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02965729
Our Lifestyles Our Lives (OLOL)
August 25, 2022 updated by: Amanda Staiano, Pennington Biomedical Research Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: No Pedometer
Participants only participated in the family-based weight management intervention.
Participants were not given a pedometer or step goals.
|
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.
|
Active Comparator: 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.
|
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.
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.
Other Names:
|
Active Comparator: 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).
|
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.
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.
Other Names:
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI Change
Time Frame: 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.
|
10 weeks
|
Body Weight Change
Time Frame: 10 weeks
|
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
Time Frame: 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.
|
10 weeks
|
Physical Activity Enjoyment Change
Time Frame: 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.
|
10 weeks
|
Subjective Health Change
Time Frame: 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.
|
10 weeks
|
Physical Activity Change
Time Frame: 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.
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Amanda E Staiano, PhD, Pennington Biomedical Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
November 14, 2016
First Submitted That Met QC Criteria
November 14, 2016
First Posted (Estimate)
November 17, 2016
Study Record Updates
Last Update Posted (Actual)
August 29, 2022
Last Update Submitted That Met QC Criteria
August 25, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 2014-012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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