Our Lifestyles Our Lives

Weight Loss Clinical Trial

— OLOL  

Official title:

Our Lifestyles, Our Lives: Obesity Treatment and Physical Activity Promotion for Underserved Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965729
• Other study ID #: PBRC 2014-012
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2022
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Children with overweight or obesity were assigned to receive the behavioral treatment alone, plus pedometers, or plus pedometers with step goals.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity
• Weight Loss

Intervention

Behavioral:
• Family-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.
• Pedometer
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
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).

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	American Council on Exercise, Our Lady of the Lake Regional Medical Center

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	10 weeks
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.	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.	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.	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.	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.	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.	10 weeks